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

• ClinicalTrials.gov Identifier: NCT02078661
• Recruitment Status: Completed
• First Posted: March 5, 2014
• Last Update Posted: March 5, 2014
• Sponsor: Rhodes Pharmaceuticals, L.P.
• Collaborator: ORA, Inc.
• Information provided by (Responsible Party): Rhodes Pharmaceuticals, L.P.

Study Description

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

Condition or disease	Intervention/treatment	Phase
Dry Eye Syndrome	Drug: PG101	Phase 1; Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: December 2013
• Actual Primary Completion Date: January 2014
• Actual Study Completion Date: January 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. At least one dry eye ocular symptom [ Time Frame: 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 :

1. At least one dry eye ocular sign measure. [ Time Frame: 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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Massachusetts

Andover Eye

Andover, Massachusetts, United States, 01810

Sponsors and Collaborators

Rhodes Pharmaceuticals, L.P.

ORA, Inc.

Investigators

• Principal Investigator: Gail Torkildsen, M.D.; Andover Eye

More Information

• Responsible Party: Rhodes Pharmaceuticals, L.P.
• ClinicalTrials.gov Identifier: NCT02078661
• Other Study ID Numbers: RP-PG-EF001; 13-110-0002 ( Other Identifier: Rhodes Pharmaceuticals L.P. )
• First Posted: March 5, 2014
• Last Update Posted: March 5, 2014
• Last Verified: March 2014

Keywords provided by Rhodes Pharmaceuticals, L.P.:

Keratoconjunctivitis sicca; Dry eye

Additional relevant MeSH terms:

Dry Eye Syndromes; Keratoconjunctivitis Sicca; Syndrome; Disease; Pathologic Processes; Lacrimal Apparatus Diseases; Eye Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases