Safety and Efficacy of PG101 for Dry Eye Syndrome

Rhodes Pharmaceuticals

Status and phase: Completed; Phase 2; Phase 1

Conditions: Dry Eye Syndrome

Treatments: Drug: PG101

Study type: Interventional

Funder types: Industry

Identifiers

NCT02078661

13-110-0002 (Other Identifier)

RP-PG-EF001

Details and patient eligibility

About

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

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 3 patient groups, including a placebo group

PG101 0.25%

Active Comparator group

Description:

Topical application of drug

Treatment:

Drug: PG101

PG101 1.0%

Active Comparator group

Description:

Topical application of drug

Treatment:

Drug: PG101

Placebo

Placebo Comparator group

Description:

Topical application of placebo

Treatment:

Drug: PG101