Actively Recruiting
OPI-NXYDLD-303 Safety and Efficacy of Phentolamine Ophthalmic Solution in Keratorefractive Surgery Participants With Decreased Mesopic Visual Acuity
Led by Ocuphire Pharma, Inc. · Updated on 2025-10-01
200
Participants Needed
23
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official 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...
- Male or female 18 years of age or older
- History of keratorefractive surgery more than 6 months before screening with night vision disturbances
- Symptoms of night vision problems started within 2 months after surgery
- Ability to follow study procedures and attend all visits
- Ability and willingness to provide written consent
- Ability to self-administer study medication
- Pupil diameter of at least 5 mm under low light conditions in at least one eye
- Mesopic low-contrast visual acuity (mLCVA) of 30 ETDRS letters or less in at least one eye
- At least 10 ETDRS letters improvement in mLCVA in one eye when the other eye is illuminated with low light during testing
You will not qualify if you...
- Unresolved dry eye diagnosis or ongoing treatment for dry eye
- History of fluctuating vision
- Significant eye diseases that affect vision or study participation
- Corneal endothelial dystrophy or presence of guttae
- Known allergy to alpha-adrenoceptor antagonists or vehicle components
- History of punctum cauterization or plug use in the study eye
- Use of extended depth-of-focus or multifocal intraocular lenses
- Eye surgery or laser procedure within 6 months before screening
- Use of any topical eye medications within 7 days before screening except certain lid scrubs
- Recent or ongoing eye infections or inflammation
- History of diabetic retinopathy, macular edema, or macular degeneration in the study eye
- History of pupil or iris conditions affecting the study eye
- Inability or unwillingness to stop wearing contact lenses as required
- Undiagnosed dry eye based on specific clinical tests
- Known allergy or contraindication to alpha- or beta-adrenoceptor antagonists systemically
- Significant systemic diseases that could interfere with the study
- Recent changes to systemic adrenergic or cholinergic drugs
- Participation in other investigational studies recently or during this study
- Pregnant, nursing, or women planning pregnancy without acceptable birth control
- Resting heart rate outside 50 to 110 beats per minute at screening
- High blood pressure above specified limits at screening
AI-Screening
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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
CONTACT
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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