ESBA105 in Patients With Severe Dry Eye

Study Overview
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Brief Summary
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The purpose of this study was to evaluate the efficacy of ESBA105 over vehicle in reducing the ocular symptoms of dry eye disease, as measured by a mean global Visual Analog Scale (VAS) discomfort score.

Detailed Description
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Following Run-In, patients qualifying for treatment were randomized 2:1 to receive ESBA105 (experimental group) or Vehicle (control group) for 4 weeks. Patients not qualifying for treatment (based on global VAS discomfort score), were discontinued from the study.

Official Title
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Evaluation of ESBA105 in the Persistent Relief of Ocular Discomfort in Patients With Severe Dry Eye

Conditions
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Eyes Dry Chronic

Intervention / Treatment
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* Biological: ESBA105 ophthalmic solution
* Other: ESBA105 vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ongoing physician diagnosis of dry eye for at least 6 months. Use of artificial tears, gels, lubricants, or re-wetting drops on a regular basis. Experience persistent ocular discomfort. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Contact lens wearers. Severe Sjogren's Syndrome. History of corneal surgery including refractive surgeries. Intraocular surgery within 6 months of Visit 1. Intraocular or periocular injection within 6 months of Visit 1. Lid function abnormalities. Use of steroids, tetracycline, doxycycline, etc., within 30 days of Visit 1. Any acute infectious or non-infectious ocular condition of the anterior or posterior segments in either eye within 30 days of Visit 1. Diseases/conditions of ocular surface associated with clinically significant scarring/destruction of conjunctiva/cornea. Other protocol-defined exclusion criteria may apply.

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESBA105<br>ESBA105 ophthalmic solution, 1 drop in each eye 3 times per day for 4 weeks | Biological: ESBA105 ophthalmic solution<br> <br> |
| Placebo Comparator: Vehicle<br>ESBA105 vehicle, 1 drop in each eye 3 times per day for 4 weeks | Other: ESBA105 vehicle<br>* Inactive ingredients used as Run-In and placebo comparator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) Global Ocular Discomfort Score, Area Under the Curve, Day 0 to Day 28 | An electronic Visual Analog Scale (eVAS) was used by the subject to assess ocular discomfort, both frequency and severity, at Day 0 (pre-treatment) and daily thereafter for 28 days. Assessments were entered into a LogPad® (handheld electronic device). The VAS frequency score ranged from 0 (rarely) to 100 (all the time), and the VAS severity score ranged from 0 (very mildly uncomfortable) to 100 (very severely uncomfortable). The Global Ocular Discomfort Score is a composite of the frequency and severity VAS scores (0-100). | Up to 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ocular discomfort