Tear Film Break-up Time After Instillation of Artificial Tears

Study Overview
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Brief Summary
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This study is an exploratory trial evaluating the tear film break-up time after a single eye drop instillation of over-the-counter artificial tears. The primary hypothesis is that tear film break up time will be greater for test than control eye.

Detailed Description
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Subjects with varying degrees of dry eye syndrome were enrolled in a randomized, controlled, double masked, single site study. A new formulation of an artificial tear containing glycerin 1% as an active with polylysine-graft-polyethylene glycol as an excipient was compared against a leading commercial product with propylene glycol (0.3%) and polyethylene glycol (0.4%) as active ingredients with hydroxypropyl-guar as a gelling agent. The primary outcome was a comparison of tear film stability after eye drop instillation.

Official Title
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A Randomized, Masked Exploratory Trial Comparing the Effect of Two Different Over-the-Counter Artificial Tear Preparations on Tear Film Break-up Time

Conditions
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Keratoconjunctivitis Sicca

Intervention / Treatment
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* Drug: glycerin
* Drug: polyethylene glycol 400/propylene glycol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years symptoms of dry eye no other history of ophthalmic problems Exclusion Criteria: Use of any ocular lubricant or ointment in the past 36 hours use of contact lenses or excessive eye lid cosmetics on the study day

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: glycerin<br>One eye will randomly receive a single instillation of one drop of a new formulation of an artificial tear containing glycerin 1% as an active with polylysine-graft-polyethylene glycol as an excipient. | Drug: glycerin<br>* Eye drop with active agent glycerin 1%, new topical ophthalmic formulation with polylysine-graft-polyethylene glycol as an excipient, single instillation.<br>* Other names: Eyeon Protect(TM);|
| Active Comparator: polyethylene glycol 400/propylene glycol<br>The other eye will receive a single instillation of one drop of an artificial tear with propylene glycol (0.3%) and polyethylene glycol (0.4%) as active ingredients with hydroxypropyl-guar as a gelling agent. | Drug: polyethylene glycol 400/propylene glycol<br>* Eye drop with the active agents polyethylene glycol 400 0.4% /propylene glycol 0.3%, topical ophthalmic formulation, single instillation<br>* Other names: Systane(R);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Noninvasive Tear Film Break-up Time | State-of-the-art methodology to assess tear stability. | 15 minutes after eye drop instillation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluorescein Tear Film Break-up Time | Standard clinical assessment methodology for assessing tear stability. | 120 minutes after eye drops instillation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ocular lubricants