Safety and Efficacy of PG101 for Dry Eye Syndrome

Study Overview
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Brief Summary
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To evaluate the safety and efficacy of 0.25% PG101 and 1.0% PG101 topical gel suspension compared to placebo when administered two times daily for 14 days in subjects diagnosed with dry eye syndrome

Detailed Description
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The topical product PG101 is expected to be efficacious in treating the symptoms of dry eye such as discomfort, dryness, grittiness, burning, stinging, photophobia, lid friction, mucus discharge and hyper-tearing. Two concentrations (0.25% and 1.0%) are included in the study to determine if there is a dose response effect.

Official Title
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A Single Center, Randomized, Double-Masked, Placebo Controlled Study Evaluating the Safety and Efficacy of 0.25% PG101 and 1.0% PG101 in Subjects With Dry Eye Syndrome

Conditions
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Dry Eye Syndrome

Intervention / Treatment
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* Drug: PG101


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be male or female of any race, at least 18 years of age Have provided verbal and written informed consent Be able and willing to follow instructions, including participation in all study assessments and visits Have a reported history of dry eye syndrome Have a history of use or desire to use eye drops for dry eye If a woman of childbearing potential, have a negative pregnancy test at Visit 1 and be using an adequate method of birth control throughout the study period Have a best corrected visual acuity of +0.70 logMAR or better in both eyes Exclusion Criteria: Have any clinically significant eye findings that require therapeutic treatment or may interfere with study parameters Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation (e.g. follicular conjunctivitis) at Visit 1 Be a woman who is pregnant, nursing or planning a pregnancy Have a known allergy and/or sensitivity to the test article or its components Have a condition or be in a situation which 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 study Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PG101 0.25%<br>Topical application of drug | Drug: PG101<br>* A topical gel containing either 1% or 0.25% PG101 active.<br>* Other names: Topical gel suspension;|
| Active Comparator: PG101 1.0%<br>Topical application of drug | Drug: PG101<br>* A topical gel containing either 1% or 0.25% PG101 active.<br>* Other names: Topical gel suspension;|
| Placebo Comparator: Placebo<br>Topical application of placebo | Drug: PG101<br>* A topical gel containing either 1% or 0.25% PG101 active.<br>* Other names: Topical gel suspension;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| At least one dry eye ocular symptom | Dry eye ocular symptoms measured are: Ocular discomfort, dryness, grittiness, burning, stinging, photophobia, lid friction, mucus discharge and hyper-tearing. | Up to 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| At least one dry eye ocular sign measure. | Dry eye ocular signs measured are: Corneal and conjunctival staining, tear break up time, OPI 2.0, Schirmer tear test, quality of life, and conjunctival redness | Up to 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Keratoconjunctivitis sicca, Dry eye