Safety and Efficacy of PG101 for Dry Eye Syndrome

Phase 1

Completed

• Conditions: Dry Eye Syndrome
• Interventions: Drug: PG101

• Registration Number: NCT02078661
• Lead Sponsor: Rhodes Pharmaceuticals, L.P.

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-20
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2014-03
• Study First Submitted QC: 2014-03-03
• Last Update Submitted: 2014-03-03
• Study First Posted: 2014-03-05
• Last Update Posted: 2014-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	PG101	Topical application of placebo
PG101 0.25%	PG101	Topical application of drug
PG101 1.0%	PG101	Topical application of drug

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
At least one dry eye ocular sign measure.	Up to 2 weeks	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

Trial Locations

Locations (1)

Andover Eye; 🇺🇸 Andover, Massachusetts, United States