Safety and Efficacy of PG101 for Dry Eye Syndrome

Dry Eye Syndrome Clinical Trial

— PG101  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02078661
• Other study ID #: RP-PG-EF001
• Secondary ID: 13-110-0002
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 20, 2013
• Last updated: March 3, 2014
• Start date: December 2013
• Est. completion date: January 2014

Study information

• Verified date: March 2014
• Source: Rhodes Pharmaceuticals, L.P.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	Andover Eye	Andover	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Rhodes Pharmaceuticals, L.P.	ORA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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