Ocuphire Pharma, Inc.
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
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
Inclusion Criteria: 1. Males or females ≥ 18 years of age 2. Able to independently comply with all protocol-mandated procedures and to attend all scheduled office visits 3. Able and willing to give written consent to participate in this study 4. Able to self-administer study medication Inclusion criteria #5, #6, #7, and #8 must all be met in the same eye: 5. History of keratorefractive surgery (eg, PRK, LASIK, SMILE, and RK/astigmatic keratotomy \[AK\]/limbal-relaxing incisions \[LRI\]) prior to 2010 in at least 1 eye and have participant reported night vision disturbances (eg, glare, hal…
Once daily dosing
Once daily dosing