Safety and Efficacy of PG101 for Dry Eye Syndrome

NCT02078661 | Completed Phase 1

• 2 other identifiers: RP-PG-EF00113-110-0002
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Conditions

Dry Eye Syndrome

Keywords

Keratoconjunctivitis sicca; Dry eye

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• At least one dry eye ocular sign measure.

  Up to 2 weeks

Study Arms (3)

PG101 0.25%

ACTIVE COMPARATOR

Topical application of drug

Drug: PG101

PG101 1.0%

ACTIVE COMPARATOR

Topical application of drug

Drug: PG101

Placebo

PLACEBO COMPARATOR

Topical application of placebo

Drug: PG101

Interventions

PG101 DRUG

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

Also known as: Topical gel, Topical gel suspension

PG101 0.25%; PG101 1.0%; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rhodes Pharmaceuticals, L.P.: lead
• ORA, Inc.: collaborator

Study Sites (1)

Andover Eye

Andover, Massachusetts, 01810, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Keratoconjunctivitis Sicca

Interventions

Gels

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Gail Torkildsen, M.D.

  Andover Eye

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2013
• First Posted: March 5, 2014
• Study Start: December 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: March 5, 2014

Record last verified: 2014-03

Locations

US (1)