Safety and Efficacy of PG101 for Dry Eye Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-01-31

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

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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.

Conditions

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Dry Eye Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PG101 0.25%

Topical application of drug

Group Type ACTIVE_COMPARATOR

PG101

Intervention Type DRUG

A topical gel containing either 1% or 0.25% PG101 active.

PG101 1.0%

Topical application of drug

Group Type ACTIVE_COMPARATOR

PG101

Intervention Type DRUG

A topical gel containing either 1% or 0.25% PG101 active.

Placebo

Topical application of placebo

Group Type PLACEBO_COMPARATOR

PG101

Intervention Type DRUG

A topical gel containing either 1% or 0.25% PG101 active.

Interventions

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PG101

A topical gel containing either 1% or 0.25% PG101 active.

Intervention Type DRUG

Other Intervention Names

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Topical gel Topical gel suspension

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No