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
Males or females ≥ 18 years of age
Able to independently comply with all protocol-mandated procedures and to attend all scheduled office visits
Able and willing to give written consent to participate in this study
Able to self-administer study medication
Prior unresolved dry eye diagnosis, taking prescription medication for dry eye (eg, drops, nasal sprays [Tyrvaya®], etc.), or taking artificial tear drops routinely for dry eye
Prior history of fluctuating vision
Clinically significant ocular disease as deemed by the Investigator (eg, untreated visually significant cataract, glaucoma, corneal edema, uveitis, severe keratoconjunctivitis sicca, retina degeneration, loss of visual field due to glaucoma or stroke, branch retinal vein occlusion, retina flare) that might interfere with the study
History or presence of corneal endothelial dystrophy (eg, Fuchs' dystrophy or presence of guttae)
Parallel
0.75% Phentolamine Ophthalmic Solution
DrugOnce daily dosing
Placebo
DrugOnce daily dosing
Percent of participants with >= 15 ETDRS letters (>= 3 lines) improvement in the study eye in mLCVA compared to Baseline (Day1 pre-dose) at Day 15
To evaluate the efficacy of POS to improve mLCVA in subjects with previous keratorefractive surgery
Percentage of participants with ≥ 15 ETDRS letters (≥ 3 lines) improvement in the study eye in mLCVA compared to Baseline (Day 1 pre-dose) at Day 8
Mean change from Baseline in Vision and Night Driving Questionnaire (VND-Q) composite score (interval scale) at Day 15
Mean change from Baseline in VND-Q Item #4 (difficulty seeing the road because of oncoming headlights when driving at night) at Day 15
Mean change from Baseline in VND-Q Item #5 (difficulty seeing because of glare when driving at dawn or dusk) at Day 15
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