Evaluation of the Tolerability and Efficacy of CWT-f-002 Lubricant Eye Drops

Study Overview
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Brief Summary
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The primary objective is to evaluate the tolerability and efficacy of CWT-f-002 lubricant eye drops in the treatment of the signs and symptoms of dry eye disease.

Detailed Description
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In this study CWT-f-002 lubricant eye drop is being evaluated in subjects with dry eye. This OTC eye drop has previously shown promising results in multiple preclinical and clinical settings. The active comparator for this study is Systane (R). Ingredient lists as follows. CWT-f-002: Active Ingredients are glycerin 0.7% and polyethylene glycol 400 0.4%. Inactive ingredients are mannitol, polylysine-graft-polyethylene glycol, sterile water for injection, and sodium phosphate buffer. Systane: Active ingredients are polyethylene glycol 400 0.4% and propylene glycol 0.3%. Inactive ingredients are boric acid, calcium chloride, hydroxypropyl guar, magnesium chloride, potassium chloride, purified water, sodium chloride, zinc chloride. Systane (R) may contain hydrochloric acid and/or sodium hydroxide to adjust pH. Both products are preservative free and supplied in unit dosers.

Official Title
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A Single-Center, Double-Masked, Randomized Study Evaluating the Tolerability and Efficacy of CWT-f-002 Lubricant Eye Drops Compared to Systane® Preservative-Free Eye Drops in the Treatment of the Signs and Symptoms of Dry Eye Disease (DED)

Conditions
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Dry Eye Disease

Intervention / Treatment
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* Drug: glycerin 0.7%/PEG 400 0.3%
* Drug: polyethylene glycol 400 0.4%/propylene glycol 0.3%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be at least 18 years of age Have a reported history of dry eye for at least 6 months Have a Tear Film Breakup Time (TFBUT) measurement of >1 and <7 seconds at Visit 1 Exclusion Criteria: Known contraindications or sensitivities to the use of the study treatment or any of its components Have a clinically significant slit lamp finding at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters Have a condition (ocular or systemic) that the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the trial

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
Interventional Model Description: Randomized, double-masked, single-center, interventional trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: glycerin 0.7%/PEG 400 0.3%<br>20 patients will receive glycerin 0.7%/PEG 400 0.3% lubricant eye drops three times per day for 28 days. | Drug: glycerin 0.7%/PEG 400 0.3%<br>* Eye drop with active agents from the OTC Monograph.<br>* Other names: CWT-f-002;|
| Active Comparator: polyethylene glycol 400 0.4%/propylene glycol 0.3%<br>10 patients will receive polyethylene glycol 400 0.4%/propylene glycol 0.3% lubricant eye drops three times per day for 28 days. | Drug: polyethylene glycol 400 0.4%/propylene glycol 0.3%<br>* Eye drop with active agents from the OTC Monograph.<br>* Other names: Systane (R);|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Corneal Epitheliopathy, Tear Film Stability