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

Study acronym: LYNX-3
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 1 month later Jun 2026 → Aug 2027
See other at-risk trials from Opus Genetics, Inc

Record History

See every version on ClinicalTrials.gov ↗

  1. Lead sponsor: Ocuphire Pharma, Inc. to Opus Genetics, Inc
    • Primary endpoints: details revised at 1 of 1 entry
    • Eligibility criteria expanded, about 31 words
    • Site details revised at 1 of 20 sites
  2. Primary and study completion pushed from Jun 2026 to Aug 2027v6 Show 5 more changesShow less
    • Enrollment reopened
    • Enrollment increased: 200 → 580 participants
    • Trial sites reduced: 23 → 20 locations
    • Secondary endpoints expanded, about 256 words
    • Eligibility criteria shortened, about 5 words
  3. Primary completion moved earlier from Aug 2027 to Jun 2026
    • Trial status changed: Recruiting → Active, Not Recruiting
    • Study completion moved earlier from Sep 2027 to Jun 2026
    • Site details revised at 23 of 23 sites
    v5
  4. Primary completion date: Mar 2026 to Aug 2027
    • Study completion date: Mar 2026 to Sep 2027
    • Site details revised at 1 of 23 sites
    v4
  5. Re-verified, no change to tracked fieldsv3
  6. Start date changed from estimate of Aug 2025 to Sep 2, 2025
    • Site details revised at 16 of 23 sites
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT07140783
Lead Sponsor Opus Genetics, Inc
Conditions
(from sponsor)		 Vision Loss Night, Vision Disorders
Related terms Vision Disorders, Vitamin A Deficiency
Enrollment 580 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov