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0.75% phentolamine ophthalmic solution for Night vision (LYNX-2 Trial)

Phase 3

Recruiting

Research Sponsored by Ocuphire Pharma, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 15

Awards & highlights

LYNX-2 Trial Summary

This trial tests if using a specific eye drop can help people who have vision problems after eye surgery.

Who is the study for?

This trial is for individuals experiencing night vision problems after refractive eye surgery. Participants should have stable post-surgery vision and no other ongoing eye conditions that could affect the study results.Check my eligibility

What is being tested?

The trial tests if a special eye drop solution, Phentolamine Ophthalmic Solution at 0.75%, can improve low-light visual sharpness in people with night vision issues post-eye surgery, compared to a placebo (a substance with no active drug).See study design

What are the potential side effects?

Potential side effects of Phentolamine may include brief stinging or burning sensation in the eyes upon application, possible headache, or uncommonly, an allergic reaction.

LYNX-2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 15

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 15

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 15 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent of subjects with an increase of at least 15 ETDRS letters read (≥ 3 lines) in the study eye in mLCVA compared to Baseline (Day 1 pre-dose) at Day 15

LYNX-2 Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: 0.75% phentolamine ophthalmic solutionActive Control1 Intervention

Daily dosing

Group II: phentolamine ophthalmic solution vehiclePlacebo Group1 Intervention

Daily dosing

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Ocuphire Pharma, Inc.Lead Sponsor

11 Previous Clinical Trials

1,461 Total Patients Enrolled

Viatris Inc.Industry Sponsor

7 Previous Clinical Trials

4,698 Total Patients Enrolled

Jay Pepose, MDStudy ChairOcuphire Pharma

1 Previous Clinical Trials

40 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies for potential participants in this research study?

"According to details on clinicaltrials.gov, this trial is presently enrolling subjects. It was first made available on April 1st, 2024 and last updated on the same date."

Answered by AI

What is the current number of individuals participating in this clinical investigation?

"Affirmative. Information available on clinicaltrials.gov confirms that recruitment for this trial is ongoing. Originally listed on April 1st, 2024, the study was last modified on the same day. The aim is to enroll a total of 200 participants across three designated sites."

Answered by AI

Has the 0.75% phentolamine eye drop been officially sanctioned by the FDA?

"Our team at Power has assessed the safety of 0.75% phentolamine ophthalmic solution to be a grade 3 on our scale due to its Phase III status, indicating existing efficacy data and robust safety profiles from various evaluations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Efficacy of 0.75% Phentolamine Ophthalmic Solution in Subjects With Post-refractive Surgery Visual Disturbances

2024. "Safety and Efficacy of 0.75% Phentolamine Ophthalmic Solution in Subjects With Post-refractive Surgery Visual Disturbances". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06349759.

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