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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
580
Once daily dosing
Once daily dosing
Arizona Eye Care
Chandler, Arizona, United States
RECRUITINGEye Doctors of Arizona
Phoenix, Arizona, United States
RECRUITINGMRB Eye Care Consultants
Scottsdale, Arizona, United States
RECRUITINGGlobal Research Management
Glendale, California, United States
RECRUITINGGordon Schanzlin New Vision
La Jolla, California, United States
RECRUITINGEye Research Foundation
Newport Beach, California, United States
RECRUITINGCalifornia Eye Specialists Medical Group
Pasadena, California, United States
RECRUITINGNVISION Clinical Research
San Diego, California, United States
RECRUITINGScripps Poway Eyecare and Optometry
San Diego, California, United States
RECRUITINGWolsten and Goldberg Eye Assoc.
Torrance, California, United States
RECRUITING...and 10 more locations
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
Time frame: Day 15
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
Time frame: 8 Days
Mean change from Baseline in Vision and Night Driving Questionnaire (VND-Q) composite score (interval scale) at Day 15
Time frame: 15 Days
Mean change from Baseline in VND-Q Item #4 (difficulty seeing the road because of oncoming headlights when driving at night) at Day 15
Time frame: 15 Days
Mean change from Baseline in VND-Q Item #5 (difficulty seeing because of glare when driving at dawn or dusk) at Day 15
Time frame: 15 Days
Mean change from Baseline in severity of halos at Day 15 on the Night-time Visual Disturbance Participant Questionnaire (NVDPQ)
Time frame: 15 Days
Mean change from Baseline in severity of starbursts at Day 15 on the NVDPQ
Time frame: 15 Days
Mean change from Baseline in overall severity of night-time visual disturbances at Day 15 on the NVDPQ
Time frame: 15 Days
Mean change from Baseline in severity of glare at Day 15 on the NVDPQ
Time frame: 15 Days
Mean and change from Baseline in study eye mLCVA at Day 15
Time frame: 15 Days
Mean and change from Baseline in study eye mesopic PD at Day 15
Time frame: 15 Days
Mean and change from Baseline (pre-dose) in study eye mLCVA at 0.5, 1, and 3 hours post dose on Day 1
Time frame: 1 Day
Mean and change from Baseline (pre-dose) in study eye mesopic PD at 0.5, 1, and 3 hours post-dose on Day 1
Time frame: 1 Day
Percentage of participants with ≥ 15 ETDRS letters improvement in study eye best corrected mHCVA compared to Baseline at Day 15
Time frame: 15 Days
Mean and change from Baseline in study eye best corrected mHCVA at Day 15
Time frame: 15 Days
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