RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-MASKED STUDY OF THE SAFETY AND EFFICACY OF POS (0.75% PHENTOLAMINE OPHTHALMIC SOLUTION) IN PARTICIPANTS WITH PREVIOUS KERATOREFRACTIVE SURGERY WITH DECREASED VISUAL ACUITY UNDER MESOPIC CONDITIONS
Ocuphire Pharma, Inc.
Summary
The goal of this clinical trial is to learn if Phentolamine Ophthalmic Solution works to treat adults that have had keratorefractive surgery and have decreased visual acuity under mesopic conditions. It will also learn about the safety of Phentolamine Ophthalmic Solution. The main questions it aims to answer are: Researchers will compare Phentolamine Ophthalmic Solution to a placebo (a look-alike substance that contains no drug) to see if Phentolamine Ophthalmic Solution works to improve vision in low light conditions. Participants will: Take Phentolamine Ophthalmic Solution or a placebo drop every day for 2 weeks Visit the clinic once every week for 2 weeks for checkups and tests Keep a diary of when they instill the study medication each evening
Description
OPI-NXYDLD-303 RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-MASKED STUDY OF THE SAFETY AND EFFICACY OF POS (0.75% PHENTOLAMINE OPHTHALMIC SOLUTION) IN PARTICIPANTS WHO HAVE PREVIOUSLY HAD KERATOREFRACTIVE SURGERY AND HAVE DECREASED VISUAL ACUITY UNDER MESOPIC CONDITIONS
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Males or females ≥ 18 years of age 2. Previous history (\>6 months prior to Screening) of keratorefractive surgery (eg, PRK, LASIK, SMILE, and RK/astigmatic keratotomy \[AK\]/limbal-relaxing incisions \[LRI\]) in one or both eyes and have participant-reported night vision disturbances (eg, glare, halos, and/or starbursts). Symptoms must have been first noted within 2 months following keratorefractive surgery 3. Able to independently comply with all protocol-mandated procedures and to attend all scheduled office visits 4. Able and willing to give written consent to parti…
Interventions
- Drug0.75% Phentolamine Ophthalmic Solution
Once daily dosing
- DrugPlacebo
Once daily dosing
Locations (23)
- Arizona Eye CareChandler, Arizona
- Carrot Eye CenterMesa, Arizona
- Eye Doctors of ArizonaPhoenix, Arizona
- MRB Eye Care ConsultantsScottsdale, Arizona
- Global Research ManagementGlendale, California
- Gordon Schanzlin New VisionLa Jolla, California