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Instilling Eye Drops

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181. Influence of Three Different Formulations of Lachrymal Substitutes on Tear Film Thickness and Other Signs and Symptoms in Patients With Moderate to Severe Dry Eye Syndrome

. The aim of the present study is to assess the influence on tear film thickness of three different formulations of topical lubricants, in particular Thealoz Duo® Eye Drops, Optive® Eye Drops and Systane Ultra® Eye Drops in patients with moderate to severe dry eye disease. In addition, standard tests for dry eye syndrome, such as the ocular surface disease index (OSDI©), Schirmer I test, corneal fluorescein staining and determination of tear break up time (BUT) will be performed to compare the product (...) : Allergan Pharmaceuticals, Ireland Active Comparator: Experimental: Patients with dry eye syndrome 3 40 Patients with dry eye syndrome Device: Systane Ultra Eye Drops Manufacturer: Alcon Pharma GmbH Outcome Measures Go to Primary Outcome Measures : Change in tear film thickness as measured with Optical Coherence Tomography (OCT) [ Time Frame: 10 weeks; at baseline, 10 minutes, 20 minutes, 40 minutes, 60 minutes, 120 minutes and 240 minutes after instillation of eye drops as well as 4 weeks and 8 weeks

2016 Clinical Trials

182. To Evaluate Eye Installation-Tear Free

information Ages Eligible for Study: 18 Years to 60 Years (Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: Yes Criteria Inclusion Criteria: Healthy males or females, 18 to 60 years with no medical conditions of the eyes as determined by the subject's medical history and confirmed by an ophthalmologist Subjects not under any doctor's care for ocular or peri orbital diseases The subject will refrain from using contact lenses, any topical facial products, any eye drops, false eyelashes, make (...) 091 Subjects were given the control article (standard shampoo mixture, X46 046) in one eye and one of the test articles in the other eye according to the randomization schedule. Drug: SPF 50 Y49 091 (BAY 987516) 5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye. Other: J & J baby shampoo, X46 046 (control) 5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye. Experimental: SPF 50 X15 158

2016 Clinical Trials

183. Safety and Efficacy of KPI-121 Compared to Placebo in Subjects With Dry Eye Disease

. Information provided by (Responsible Party): Kala Pharmaceuticals, Inc. Study Details Study Description Go to Brief Summary: The primary purpose of this study is to determine the efficacy and safety of KPI-121 0.25% ophthalmic suspension compared to vehicle (placebo) in subjects who have a documented clinical diagnosis of dry eye disease. The product will be studied over 14 days, with 1-2 drops instilled in each eye four times daily (QID). Condition or disease Intervention/treatment Phase Dry Eye (...) of the Investigator or study coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops. Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02819284 Sponsors and Collaborators Kala Pharmaceuticals, Inc. More

2016 Clinical Trials

184. Topical Ophthalmic AGN-195263 for the Treatment of Evaporative Dry Eye

Intervention/treatment Experimental: AGN-195263 Drug: AGN-195263 1 drop of AGN-195263 will be instilled in each eye twice daily. Placebo Comparator: Vehicle Drug: Vehicle 1 drop of AGN-195263 vehicle (placebo) will be instilled in each eye twice daily. Outcome Measures Go to Primary Outcome Measures : Overall Ocular Discomfort Score (0 to 4 Scale; 0=None, 4=Very Severe) [ Time Frame: 6 month visit ] The overall ocular discomfort will be assessed on a questionnaire using a 0 to 4 scale on which 0=none, 1 (...) Topical Ophthalmic AGN-195263 for the Treatment of Evaporative Dry Eye Topical Ophthalmic AGN-195263 for the Treatment of Evaporative Dry Eye - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Topical

2016 Clinical Trials

185. Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease

. Study Details Study Description Go to Brief Summary: The primary purpose of this study is to determine the efficacy and safety of KPI-121 0.25% ophthalmic suspension compared to vehicle (placebo) in subjects who have a documented clinical diagnosis of dry eye disease. The product will be studied over 14 days, with 1-2 drops instilled in each eye four times daily (QID). Condition or disease Intervention/treatment Phase Dry Eye Syndromes Keratoconjunctivitis Sicca Drug: KPI-121 0.25% Ophthalmic (...) to successfully instill eye drops. Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813265 Sponsors and Collaborators Kala Pharmaceuticals, Inc. More Information Go to Layout table for additonal information Responsible Party: Kala Pharmaceuticals, Inc

2016 Clinical Trials

186. Effect of different lubricant eye gels on tear film thickness as measured with ultrahigh-resolution optical coherence tomography. Full Text available with Trip Pro

unpreserved trehalose 3% + hyaluronic acid 0.15% (TH), hyaluronic acid 0.2% (HA) or polyethylene glycol 0.4% + propylene glycol 0.3% (PP) eye drops. In total, 60 patients were included and TFT was measured using a custom-built UHR-OCT system.The mean TFT at baseline was 3.5 ± 0.7 μm. There was a significant difference in the time-course of TFT between the three groups (p = 0.001 between groups). Ten minutes after instillation, TFT increased by 155.8 ± 86.6%, 65.7 ± 71.5% and 33.4 ± 19.6% in the PP, TH (...) Effect of different lubricant eye gels on tear film thickness as measured with ultrahigh-resolution optical coherence tomography. To compare the effect of a single drop of different lubricant eye gels on tear film thickness (TFT) as measured with ultrahigh-resolution optical coherence tomography (UHR-OCT) in patients with mild-to-moderate dry eye disease (DED).The study followed a randomized, single-masked, observer-blinded parallel group design. Patients received a single dose of either

2016 Acta ophthalmologica Controlled trial quality: uncertain

187. Immediate Effects of 3% Diquafosol and 0.1% Hyaluronic Acid Ophthalmic Solution on Tear Break-Up Time in Normal Human Eyes. (Abstract)

Immediate Effects of 3% Diquafosol and 0.1% Hyaluronic Acid Ophthalmic Solution on Tear Break-Up Time in Normal Human Eyes. The purpose of this study was to evaluate the immediate effect of 3% diquafosol ophthalmic solution on tear break-up time (TBUT) in normal human eyes, and to compare it with that of saline and 0.1% hyaluronate ophthalmic solution.Cross sectional comparative study in the first study, 10 healthy volunteers underwent topical application of 2 different ophthalmic solutions (...) in each eye. Saline was randomly applied to one eye and 3% diquafosol ophthalmic solution was added to the fellow eye. TBUT was measured and video recorded before application and at 5, 10, 15, and 20 min after. The TBUT in each eye was compared at each time point with regard to the 2 different ophthalmic solutions. In the second study, another 10 healthy volunteers were included. The same methods were used to compare the immediate effects of 0.1% hyaluronate and 3% diquafosol ophthalmic solution

2015 Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics Controlled trial quality: uncertain

188. Effects of Topical Fucosyl-Lactose, a Milk Oligosaccharide, on Dry Eye Model: An Example of Nutraceutical Candidate Full Text available with Trip Pro

test), tear film breakup time (TBUT), corneal staining and tear osmolarity were assessed. Fucosyl-lactose eye drops was instilled at different concentrations (0.01, 0.1, and, 1%).After 24 h from first atropine administration, tear volume and TBUT values were significantly improved in groups treated with 2-fucosyl-lactose in a dose-dependent manner. Tear volume increased from 5.25 to 10.75 mm and TBUT values from 8.75 to 34.5 s with 0.01% or 1% 2-fucosyl-lactose treatment, respectively. No changes (...) Effects of Topical Fucosyl-Lactose, a Milk Oligosaccharide, on Dry Eye Model: An Example of Nutraceutical Candidate Colostrum has been proposed to treat severe dryness and problematic eye lesions showing a beneficial effect. The aim of the study was to investigate the effect of 2-fucosyl-lactose, a natural sugar present in the human colostrum, in an experimental dry eye.Dry eye was induced in adult male New Zealand albino rabbits by topical administration of 1% atropine. Tear volume (Schirmer's

2015 Frontiers in pharmacology

189. Clinical Evaluation Following Use of SYSTANE® ULTRA in the Management of Dry Eye

Information provided by (Responsible Party): Alcon Research Study Details Study Description Go to Brief Summary: The purpose of this study is to evaluate the clinical benefits of SYSTANE® ULTRA Lubricant Eye Drops using total ocular surface staining scores in subjects with dry eye administering it either as a scheduled regimen or as-needed after 28 days of treatment. Condition or disease Intervention/treatment Phase Dry Eye Syndrome Drug: SYSTANE® ULTRA Lubricant Eye Drops Not Applicable Detailed (...) to Primary Outcome Measures : Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 28 [ Time Frame: Baseline (Day 0), Day 28 ] The TOSS score is a cumulative cornea and conjunctival staining score. After instilling ophthalmic dye in the eye, the investigator graded three areas of the ocular surface for dryness on a scale from 0 to 5, where 0 is "Absent" and 5 is "Severe." The three scores were summed for a resultant overall 0-15 score. The change from baseline was calculated

2015 Clinical Trials

190. Tear film thickness after treatment with artificial tears in patients with moderate dry eye disease. (Abstract)

Tear film thickness after treatment with artificial tears in patients with moderate dry eye disease. This study was designed to investigate the effect of a single-drop instillation of different lacrimal substitutes on tear film thickness (TFT) assessed with optical coherence tomography in patients with mild to moderate dry eye disease.The study was performed in a randomized, double-masked, controlled parallel group design. Patients received a single dose of either unpreserved trehalose 30 mg/mL (...) and sodium hyaluronate 1.5 mg/mL (TH-SH, Thealoz Duo), unpreserved sodium hyaluronate, 0.15% (HA, Hyabak) or sodium chloride, 0.9% (NaCl, Hydrabak) eye drops. Sixty patients finished the study according to the protocol. TFT was measured with a custom-built ultrahigh-resolution Fourier domain optical coherence tomography system providing a resolution of 1.2 μm.The mean TFT before treatment was 2.5 ± 0.4 μm. Ten minutes after instillation, TFT significantly increased in the TH-SH group from 2.4 ± 0.4

2015 Cornea Controlled trial quality: uncertain

191. Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-1

for the Treatment of Dry Eye: ARISE-1 Study Start Date : September 2015 Actual Primary Completion Date : June 2016 Actual Study Completion Date : July 2016 Arms and Interventions Go to Arm Intervention/treatment Experimental: High Dose RGN-259 High dose RGN-259: It is a preservative-free, sterile eye drop solution containing Tβ4 Drug: RGN-259 A preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into each eye, four times a day (QID) for 28 days Other Names: Tβ4 Thymosin Beta 4 (...) Placebo Comparator: Placebo It is composed of the same excipients as RGN-259 but does not contain Tβ4 Drug: Placebo It is composed of the same excipients as RGN-259 but does not contain Tβ4 Other Name: Vehicle Control Experimental: Low Dose RGN-259 Low dose RGN-259: It is a preservative-free, sterile eye drop solution containing Tβ4 Drug: RGN-259 A preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into each eye, four times a day (QID) for 28 days Other Names: Tβ4

2015 Clinical Trials

192. Added Benefits of Lachrymal Substitute Gel During the Night in Patients With Moderate to Severe Dry Eye Syndrome

by the use of artificial tears during the day. Nighttime relief is often achieved by substances known to be more adhesive to the ocular surface, such as gels. Condition or disease Intervention/treatment Phase Dry Eye Syndromes Device: Thealoz Duo Gel and Thealoz Duo eye drops Device: Thealoz Duo eye drops Not Applicable Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 45 participants Allocation: Randomized Intervention Model: Crossover (...) of drops of Thealoz Duo instilled during the day (patient diary) [ Time Frame: 4 weeks ] Tear break up time [ Time Frame: 4 weeks ] Conjunctival and corneal staining [ Time Frame: 4 weeks ] Schirmer 1 Test [ Time Frame: 4 weeks ] OSDI questionnaire [ Time Frame: 4 weeks ] Ocular Surface Disease Index Questionnaire Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members

2015 Clinical Trials

193. Delivery of Topically Applied Calpain Inhibitory Peptide to the Posterior Segment of the Rat Eye Full Text available with Trip Pro

of the eye. Immunoactivities gradually diminished at 3 and 6 h after the final eye drop. Quantitative estimations of the amount of peptide in the retina were 15.3, 5.8 and 1.0 pg/μg protein at 1, 3 and 6 h after the final instillation, respectively. Current results suggest that while the topically applied Tat-μCL peptide reaches the posterior segment of the retina and the optic nerve, the sufficient concentration (> IC50) is maintained for at least 6 h in the rat retina. Our findings suggest (...) topical application in adult rats. Distribution of the peptide was determined by immunohistochemical analysis, and enzyme-linked immune-absorbent assay was used to quantify the accumulation in the retina. Peptides were prominently detected in both the anterior and posterior segments of the eye at 1 h after the final eye drop application. Immunohistochemically positive reactions were observed in the retina, optic nerve, choroid, sclera and the retrobulbar tissues, even in the posterior portion

2015 PloS one

194. An upright eyedrop bottle: accuracy, usage of excess drops, and contamination compared to a conventional bottle Full Text available with Trip Pro

usage, participants were observed instilling eyedrops. Participants were instructed to instill a single eyedrop in each eye with both a standard bottle and the UEB. They repeated this process three times. With each trial, the amount of time taken to instill drops was recorded, as well as whether a drop landed in the eye (accuracy), if excess drops were used, and if the bottle tip was contaminated.Forty participants were enrolled, with an average age of 72.4±8.9 years; the majority were females (24 (...) females). Thirty-four participants had been using eyedrops for at least 1 year. The time required to instill eyedrops was significantly less with the UEB in the second and third trials. There was no difference in accuracy between the conventional bottle and the UEB in the left or right eye in any trials. Significantly more participants used excess number of drops while using the conventional bottle in both the left and right eyes in all three trials. The bottle tip was never contaminated with the UEB

2016 Clinical ophthalmology (Auckland, N.Z.)

195. Evaluation of the Effectiveness of ST266 Ophthalmic Drops Compared to Placebo to Treat Allergic Conjunctivitis

: Group 2 Placebo dosed 4 times a day for 8 days Drug: Saline (0.9% NaCl) One (1) drop of saline ophthalmic eye drops will be administered to each eye 4 times a day for 8 days. Outcome Measures Go to Primary Outcome Measures : Ocular itching [ Time Frame: Day 8 ] Ocular itching evaluated by the subject. Conjunctival redness [ Time Frame: Day 8 ] Conjunctival redness evaluated by the investigator. Secondary Outcome Measures : Ocular itching [ Time Frame: Day 7 ] Ocular itching evaluated by the subject (...) ; have a positive post-CAC reaction; have a positive post-CAC reaction in two out of the first three time points; be able to self-administer eye drops satisfactorily or have a caregiver at home routinely available for this purpose. Exclusion Criteria: have known contraindications or sensitivities to the use of the investigational product or any of its components; have any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters (including

2016 Clinical Trials

196. Evaluation of Tear Osmolarity Over Time With Sustained Use of Thera Tears Lubricating Drops

Osmolarity Over Time With Sustained Use of Thera Tears Lubricating Study Start Date : October 2015 Actual Primary Completion Date : March 2016 Actual Study Completion Date : March 2016 Resource links provided by the National Library of Medicine related topics: available for: Arms and Interventions Go to Arm Intervention/treatment Experimental: TheraTears Lubrication Drop TheraTears Lubricating Eye Drops to be instilled 1 drop in both eyes 4 times per day over a period of 8 weeks. Drug: TheraTears (...) between the two eyes. Exclusion Criteria: Has taken part in another research study within the last 30 days; Planned contact lens wear during the course of the study; Staff at the investigational site or family member of site staff or family member of currently enrolled participant; Any subject that violates the washout period by using eye drops during the 72hrs washout period; Has any known ocular disease* including active ocular infection, inflammation or allergy, especially Salzmann's nodular

2016 Clinical Trials

197. A Clinical Randomized Trial Comparing the Cycloplegic Effect of Cyclopentolate Drops Applied to Closed Eyelids Versus Open Eyelids. (Abstract)

for annual refraction were enrolled. Three were excluded as they did not finish the testing. One drop of Alcaine® and one drop of cyclopentolate HCL 1% were used in each eye. Cyclopentolate drops were placed on the inner canthus near the lid margin on the closed eye and directly onto the conjunctiva of the fellow eye.Overall, 145/174 eyes (83%) were fully cyclopleged with one drop. The methods of instillation were equally successful (seventy-two indirect vs. seventy-three direct). Age, eye color (...) A Clinical Randomized Trial Comparing the Cycloplegic Effect of Cyclopentolate Drops Applied to Closed Eyelids Versus Open Eyelids. Adequate cycloplegia and dilation are required for refraction and fundus exam in children. Standard practice is to instill cycloplegic drops in the inferior cul-de-sac, and this is often traumatic for children. Our study assesses the use of cyclopentolate on closed lids as a method of instillation for ensuring complete cycloplegia.Ninety children presenting

2016 The American orthoptic journal Controlled trial quality: uncertain

198. Pupil dilation using drops vs gel: a comparative study Full Text available with Trip Pro

Pupil dilation using drops vs gel: a comparative study To compare the efficacy in pupil dilation and degree of discomfort between topical instillation of mydriatic drops and gel.The study included 60 patients with no previous ocular history of trauma and surgery. One eye was dilated with two drops (tropicamide 0.5% and phenylephrine 10%), and the other with one drop of gel (tropicamide 0.5%+phenylephrine 5%). Pupil size was measured by a Colvard pupillometer at baseline and 5, 15, 30, and 45 (...)  min following instillation. Pain upon instillation was measured by visual analog scale (VAS).There was no difference in pupil size at baseline. Use of the gel achieved greater mydriasis than drops (P=0.01), and was also associated with lower pain scores (P=0.003). In diabetic patients, pupil size was smaller at baseline and following instillation of drops and gel. Use of the gel achieved an even greater degree of pupil dilation in this subset of patients than drops (P=0.019).Gel formulation

2015 Eye

199. A preliminary investigation into the effects of ocular lubricants on higher order aberrations in normal and dry eye subjects. Full Text available with Trip Pro

A preliminary investigation into the effects of ocular lubricants on higher order aberrations in normal and dry eye subjects. To study the effects of ocular lubricants on higher order aberrations in normal and self-diagnosed dry eyes.Unpreserved hypromellose drops, Tears Again™ liposome spray and a combination of both were administered to the right eye of 24 normal and 24 dry eye subjects following classification according to a 5 point questionnaire. Total ocular higher order aberrations, coma (...) intervention.Hypromellose drops caused an increase in total higher order aberrations (p=<0.01 in normal and dry eyes) and a reduction in Strehl ratio (normal eyes: p=<0.01, dry eyes p=0.01) immediately after instillation. There were no significant differences between normal and self-diagnosed dry eyes for response to intervention and no improvement in visual quality or reduction in higher order aberrations after 60 min. Differences in comfort levels failed to reach statistical significance.Combining treatments does

2014 Contact lens & anterior eye : the journal of the British Contact Lens Association Controlled trial quality: uncertain

200. Ocular tolerability and efficacy of a cationic emulsion in patients with mild to moderate dry eye disease - A randomised comparative study. (Abstract)

] and for the Van Bijsterveld score [CE: -1.4 ± 1.2; PVA-P: -0.9 ± 1.2; P=0.046] in the CE group. The same applied for the palpebral erythema score (P=0.023), overall efficacy assessed by the investigators (P<0.001), and symptoms not related to eye drop instillation (P=0.021). Improvement was observed from D7. No difference was observed between the two treatments with regard to ocular safety.These results suggest that in patients with mild to moderate dry eye, Cationorm, in addition to its moisturizing (...) objective criteria were assessed to compare the two eye drops: tear Break-up Time (TBUT), Schirmer's test, lissamine green staining (Van Bijsterveld score), corneal fluorescein staining (Oxford scale) and oculopalpebral examination, on D7 and D28 (end of study). At these visits, ocular symptoms and safety were also assessed.Seventy-nine patients were randomised: CE: 44 patients; PVA-P: 35 patients. At D28, improvement was significantly better for TBUT [CE: 1.7 ± 2.4 s; PVA-P: 0.6 ± 1.8 s; P=0.015

2014 Journal français d'ophtalmologie Controlled trial quality: uncertain

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