Residence Time Evaluation of Marketed OTC Ophthalmic Products

Study Overview
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Brief Summary
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The objective of this study is to measure ocular surface residence time (in minutes) of two marketed OTC ophthalmic products in dry eye patients.

Conditions
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Dry Eye

Intervention / Treatment
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* Other: Systane Ultra Lubricant Eye Drops
* Other: Unisol 4 Saline Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent and HIPAA read, signed and dated before conducting any procedures. Adult volunteers diagnosed with mild to moderate dry eye. Criteria for diagnosis must include 2 of the 3 following characteristics: composite symptom score > or = to 5 on modified Schein questionnaire; NaFl TFBUT < or = to 7 seconds in either eye; or NaFl corneal staining sum score > or = to 3 (using 0-15 point grading system). Able and willing to follow study instructions. 4) Best-corrected V.A. of 0.6 logMAR or better OU. Exclusion Criteria: History or evidence of ocular or intraocular surgery in either eye w/i the past 6 months. History or evidence of serious ocular trauma in either eye w/i the past 6 months. History of intolerance or hypersensitivity to any component of the study medications. History or evidence of epithelial herpes simplex keratitis, vaccinia, active or recent varicella viral disease of the cornea and/or conjunctiva and/or eyelids, mycobacterial infection of the eye, and/or fungal disease of the eye. Use of concomitant topical ocular medications during the study period. Patients using systemic medications that may contribute to dry eye may not be enrolled unless they have been on a stable dosing regimen for a minimum of 30 days prior to Visit 1, and the dosing regimen must remain stable throughout the study period. Ocular conditions such as conjunctival infections, iritis, or any other ocular condition that may preclude the safe admininstration of the test article. Individuals unwilling to d/c contact lens wear during the study period. CL wear must have been d/c at least one week prior to Visit 1. Participation in an investigational drug or device study w/i 30 days of entering this study. Additionally, any subject may be declared ineligible for a valid medical reason.

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Systane<br>One drop dispensed into each eye | Other: Systane Ultra Lubricant Eye Drops<br>* artificial tears solution for lubricating the cornea<br>|
| Active Comparator: Unisol<br>One drop dispensed into each eye | Other: Unisol 4 Saline Solution<br>* saline solution for irrigating the cornea<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Surface Residence Time | Ocular surface residence time is the time for fluorescent intensity of the cornea to return to baseline measurement after installation of test article. | After 8 minutes, then every 2 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dry eye, autofluorescence, residence time