OPI-NXYDLD-303 Safety and Efficacy of Phentolamine Ophthalmic Solution in Keratorefractive Surgery Participants With Decreased Mesopic Visual Acuity

Conditions

• Vision Disorders
• Vision Loss Night

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 0.75% Phentolamine Ophthalmic Solution — DRUG
  Once daily dosing
• Placebo — DRUG
  Once daily dosing

Study Details

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

Key Dates

First listed

Aug 26, 2025

Start date

Sep 2, 2025

Status verified

Sep 2026

Primary completion

Aug 31, 2027

Completion

Aug 31, 2027

Study Design

Enrollment

580 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 0.75% Phentolamine Ophthalmic Solution
  0.75% Phentolamine Ophthalmic Solution
• Placebo Comparator: Placebo - Phentolamine Ophthalmic Solution vehicle
  Placebo-phentolamine ophthalmic solution vehicle

Primary Outcome Measure

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 [ Time Frame: Day 15 ]

Central Contacts

• Study Director
  984-884-6030
  [email protected]

Locations (20)

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