Efficacy and Safety of PL9643 Ophthalmic Solution in Subjects With Dry Eye
Completed · Phase 2 · Has a placebo group
Conditions studied: Dry Eye Disease
In brief
Evaluation of safety and efficacy of PL9643 Ophthalmic Solution compared to placebo for the treatment of the signs and symptoms of dry eye.
Key facts
- Study ID
- NCT04268069
- Run by
- ORA, Inc.
- People needed
- 160
- Starts
- 2020-02-14
- Expected to finish
- 2020-10-05
- Last updated by the study team
- 2020-11-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Be at least 18 years of age.
- Provided written informed consent.
- Have a reported history of dry eye
- Have a history of use or desire to use eye drops for dry eye symptoms
- Have corrected visual acuity greater than or equal to +0.7 in both eyes
You may not qualify if…
- Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal)
- Have any planned ocular and/or lid surgeries over the study period.
- Have an uncontrolled systemic disease.
- Be a woman who is pregnant, nursing or planning a pregnancy.
- Be a woman of childbearing potential who is not using an acceptable means of birth control
- 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
- Have used an investigational drug or device within 30 days of Visit 1
- Be unable or unwilling to follow instructions, including participation in all study assessments and visits
Where it is running
- Andover Eye Associates — Andover, Massachusetts, United States
- Andover Eye Associates — Raynham, Massachusetts, United States
- Vita Eye Clinc — Shelby, North Carolina, United States
- Total Eye Care, P.A. — Memphis, Tennessee, United States
Full record on ClinicalTrials.gov
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