Safety and Efficacy of PG101 for Dry Eye Syndrome
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Dry Eye Syndrome
In brief
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
Key facts
- Study ID
- NCT02078661
- Run by
- Rhodes Pharmaceuticals, L.P.
- People needed
- 72
- Starts
- 2013-12-01
- Expected to finish
- 2014-01-01
- Last updated by the study team
- 2014-03-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Andover Eye — Andover, Massachusetts, United States
Full record on ClinicalTrials.gov
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