Safety and Efficacy of PG101 for Dry Eye Syndrome (PG101)

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

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

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndrome
• Intervention / Treatment: Drug: PG101

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 Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • Andover Eye

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rhodes Pharmaceuticals, L.P.
• Collaborators: ORA, Inc.
• Investigators: Principal Investigator: Gail Torkildsen, M.D., Andover Eye

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: December 20, 2013
• First Submitted That Met QC Criteria: March 3, 2014
• First Posted (Estimate): March 5, 2014

Study Record Updates

• Last Update Posted (Estimate): March 5, 2014
• Last Update Submitted That Met QC Criteria: March 3, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Dry eye; Keratoconjunctivitis sicca
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: RP-PG-EF001; 13-110-0002 (Other Identifier: Rhodes Pharmaceuticals L.P.)