Actively Recruiting
Randomized, Placebo-Controlled Study of 0.75% Phentolamine Ophthalmic Solution for Adults With Decreased Vision After Keratorefractive Surgery
Led by Ocuphire Pharma, Inc. · Updated on 2025-10-01
200
Participants Needed
23
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying adults who have had keratorefractive surgery and experience decreased vision in low light (mesopic) conditions. The main goal is to find out if Phentolamine Ophthalmic Solution can improve vision under these conditions and to evaluate its safety. This is a phase 3, randomized, placebo-controlled, double-masked clinical trial comparing the study drug to a placebo. Participants will receive either 0.75% Phentolamine Ophthalmic Solution or a placebo eye drop once daily for 2 weeks. The study includes two groups: one using the active drug and the other using a placebo solution. Participants will visit the clinic weekly during this treatment period for checkups and tests, and they will keep a diary to record when they apply the drops each evening. During the study, participants will undergo vision tests to measure improvements in low-light visual acuity, including the primary outcome of the percentage of participants with significant improvement in letter reading ability at day 15. Safety will be monitored throughout the trial. The total participation time for each participant is about two weeks, with regular assessments and adherence monitoring to the medication schedule.
CONDITIONS
Brief Title
OPI-NXYDLD-303 Safety and Efficacy of Phentolamine Ophthalmic Solution in Keratorefractive Surgery Participants With Decreased Mesopic Visual Acuity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 18 years or older
- Previous keratorefractive surgery performed more than 6 months before screening
- Participant-reported night vision disturbances starting within 2 months after surgery
- Able to independently follow study procedures and attend scheduled visits
- Able and willing to provide written consent
- Able to self-administer study medication
- Pupil diameter 5 mm or greater under mesopic conditions in at least one eye
- Mesopic low-contrast visual acuity of 30 or fewer ETDRS letters in at least one eye
- At least 10 ETDRS letters improvement in vision under specific light conditions in at least one eye
You will not qualify if you...
- Unresolved dry eye diagnosis or current use of prescription dry eye medication or artificial tears
- History of fluctuating vision
- Significant eye diseases that could interfere with the study (eg, cataract, glaucoma, corneal edema, uveitis, retina degeneration)
- Corneal endothelial dystrophy such as Fuchs' dystrophy
- Known allergy to alpha-adrenoceptor antagonists or study vehicle components
- History of punctal cauterization or plug insertion/removal in the study eye
- Use of multifocal or extended depth-of-focus intraocular lenses
- Eye surgery or laser procedure within 6 months before screening
- Use of topical ophthalmic medications within 7 days before screening (except lid scrubs)
- Recent or current eye infection or inflammation
- History of diabetic retinopathy, macular edema, or macular degeneration in the study eye
- Traumatic or nontraumatic pupil or iris conditions
- Inability or unwillingness to stop wearing contact lenses before visits
- Newly diagnosed dry eye by investigator criteria
- Known hypersensitivity to alpha- or beta-adrenoceptor antagonists
- Significant systemic diseases that could interfere with the study
- Changes in systemic adrenergic or cholinergic drug treatments within 7 days prior to screening or during the study
- Participation in other investigational studies within 30 days before screening or during this study
- Previous participation in investigational studies using Phentolamine Ophthalmic Solution
- Pregnant or nursing females or those not using medically acceptable birth control
- Resting heart rate outside 50 to 110 beats per minute at screening
- Hypertension with blood pressure above specified limits at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 15 days
Participants receive once daily dosing of 0.75% Phentolamine Ophthalmic Solution or placebo.
Baseline visit and 1 follow-up visit
Trial Site Locations
Total: 23 locations
1
Arizona Eye Care
Chandler, Arizona, United States, 85224
Actively Recruiting
2
Carrot Eye Center
Mesa, Arizona, United States, 85202
Actively Recruiting
3
Eye Doctors of Arizona
Phoenix, Arizona, United States, 85028
Actively Recruiting
4
MRB Eye Care Consultants
Scottsdale, Arizona, United States, 85254
Actively Recruiting
5
Global Research Management
Glendale, California, United States, 91204
Actively Recruiting
6
Gordon Schanzlin New Vision
La Jolla, California, United States, 92037
Actively Recruiting
7
Eye Research Foundation
Newport Beach, California, United States, 92663
Actively Recruiting
8
California Eye Specialists Medical Group
Pasadena, California, United States, 91107
Actively Recruiting
9
NVISION Clinical Research
San Diego, California, United States, 92117
Actively Recruiting
10
Scripps Poway Eyecare and Optometry
San Diego, California, United States, 92130
Actively Recruiting
11
Wolsten and Goldberg Eye Assoc.
Torrance, California, United States, 90505
Actively Recruiting
12
Glaucoma Specialist of South Florida
Delray Beach, Florida, United States, 33484
Actively Recruiting
13
Segal Drug Trials
Delray Beach, Florida, United States, 33484
Actively Recruiting
14
Wyse Eyecare
Northbrook, Illinois, United States, 60062
Actively Recruiting
15
Virdi Eye Clinic
Rock Island, Illinois, United States, 61201
Actively Recruiting
16
Durrie Vision
Overland Park, Kansas, United States, 66210
Actively Recruiting
17
Kannarr Eye Care
Pittsburg, Kansas, United States, 66762
Actively Recruiting
18
Eye Health Vision Center
South Dartmouth, Massachusetts, United States, 02747
Actively Recruiting
19
Northeast Eye Research Associates
Woburn, Massachusetts, United States, 01801
Actively Recruiting
20
Oculus Research
Garner, North Carolina, United States, 27529
Actively Recruiting
21
West Bay Eye Assoc.
Warwick, Rhode Island, United States, 02888
Actively Recruiting
22
Zillan Clinical Research
Houston, Texas, United States, 77082
Actively Recruiting
23
Hoopes Vision
Draper, Utah, United States, 84020
Actively Recruiting
Research Team
S
Study Director
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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