Phentolamine Ophthalmic Solution for Night Blindness

(LYNX-3 Trial)

Recruiting at 22 trial locations

Overseen By Roselyn Judd

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Ocuphire Pharma, Inc.

Must not be taking: Alpha antagonists, Beta antagonists

Disqualifiers: Dry eye, Fluctuating vision, Cataract, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Phentolamine Ophthalmic Solution (an eye drop) can improve night vision in individuals who have undergone keratorefractive surgery (such as LASIK or PRK) and now experience night vision issues like glare or halos. Participants will use either the eye drop or a placebo daily for two weeks to assess improvement in low-light conditions. The study also evaluates the treatment's safety. Ideal candidates are those who had surgery at least six months ago and continue to report night vision disturbances. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial requires that you stop using any topical prescription or over-the-counter eye medications, including artificial tear drops, at least 7 days before the screening and throughout the study. If you are taking systemic adrenergic or cholinergic drugs, you should not start or change the dosage within 7 days before the screening or during the study.

Is there any evidence suggesting that Phentolamine Ophthalmic Solution is likely to be safe for humans?

Research has shown that Phentolamine Ophthalmic Solution is generally safe for people. In earlier studies, most participants experienced only mild side effects, such as slight eye irritation or redness. Importantly, no serious health problems were linked to the treatment.

The treatment's late stage of testing indicates that it has been safe enough in earlier trials to warrant continued study. Additionally, the FDA has recognized its potential benefits by granting it Fast Track status, which is often given to treatments that show promise for serious conditions and have a good safety record.

Overall, Phentolamine Ophthalmic Solution appears to be a safe option for those considering joining the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for night blindness?

Unlike most treatments for night blindness that focus on dietary changes or vitamin A supplements, Phentolamine Ophthalmic Solution offers a novel approach by using a topical application directly to the eyes. This solution contains phentolamine, which is known to improve blood flow and potentially enhance night vision more quickly than existing treatments. Researchers are excited about its potential to provide a faster, more direct improvement in night vision, offering hope for those who haven't found relief with traditional methods.

What evidence suggests that Phentolamine Ophthalmic Solution might be an effective treatment for night blindness?

Research has shown that Phentolamine Eye Drops can enhance night vision after certain types of eye surgery for vision correction. In earlier studies, 27.2% of participants using the drops experienced noticeable improvement in low-light vision. Another study found that 17.3% of participants saw significant improvement, enabling them to read 15 or more additional letters on a vision test. This trial will compare the effectiveness of 0.75% Phentolamine Ophthalmic Solution to a placebo. These findings suggest that Phentolamine Eye Drops might improve night vision for those struggling to see clearly in dim light. ^{5 6 7 8 9}

Who Is on the Research Team?

Jay Pepose, MD

Principal Investigator

Opus Genetics/Ocuphire Pharma

Are You a Good Fit for This Trial?

Adults who've had keratorefractive surgery (like LASIK) and now have trouble seeing in low light can join this trial. Specific details about eligibility criteria are not provided, but typically participants must meet certain health standards.

Inclusion Criteria

Able and willing to give written consent to participate in this study

PD ≥ 5 mm under mesopic conditions in at least 1 eye

mLCVA ≤ 30 Early Treatment Diabetic Retinopathy Study (ETDRS) letters in at least 1 eye

Exclusion Criteria

I have a history of corneal endothelial dystrophy.

Known hypersensitivity to any topical alpha-adrenoceptor antagonists

Known allergy or contraindication to any component of the vehicle formulation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take Phentolamine Ophthalmic Solution or a placebo drop every day for 2 weeks

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Phentolamine Ophthalmic Solution

Trial Overview The trial is testing Phentolamine Ophthalmic Solution against a placebo to see if it improves night vision after eye surgery. Participants will use the drops daily for two weeks and attend weekly clinic visits for checkups and tests.

How Is the Trial Designed?

Group I: 0.75% Phentolamine Ophthalmic Solution Experimental Treatment 1 Intervention

0.75% Phentolamine Ophthalmic Solution

Group II: Placebo - Phentolamine Ophthalmic Solution vehicle Placebo Group 1 Intervention

Placebo-phentolamine ophthalmic solution vehicle

Who Is Running the Clinical Trial?

Ocuphire Pharma, Inc.

Lead Sponsor

Trials

13

Recruited

2,200+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9548101/

A randomized phase 2 clinical trial of phentolamine ... Key efficacy outcomes were change from baseline in pupil diameter, contrast sensitivity, and visual acuity. Safety measures including ...

2. ir.opusgtx.com ir.opusgtx.com/press-releases/detail/488/opus-genetics-announces-lynx-2-phase-3-trial-met-its-primary-endpoint-for-phentolamine-ophthalmic-solution-0-75-in-keratorefractive-patients-with-visual-disturbances-under-mesopic-low-contrast-conditions

Opus Genetics Announces LYNX-2 Phase 3 Trial Met its ... In the study, 17.3% of patients treated with Phentolamine Ophthalmic Solution 0.75% achieved a ≥15-letter Early Treatment Diabetic Retinopathy ...

3. ophthalmologytimes.com ophthalmologytimes.com/view/opus-genetics-reports-positive-phase-3-results-for-phentolamine-ophthalmic-solution-0-75-

Opus Genetics reports positive phase 3 results for ... Results showed a statistically significant number of participants (27.2%) treated with phentolamine ophthalmic solution 0.75% met this endpoint, ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04638660

Safety and Efficacy of Nyxol (0.75% Phentolamine ... The objectives of this study are: To evaluate the efficacy of Nyxol to improve mesopic low contrast visual acuity (mLCVA) in subjects with Dim Light Vision ...

5. modernod.com modernod.com/news/opus-genetics-phase-3-trial-for-phentolamine-ophthalmic-solution-meets-primary-endpoint-for-night-vision/2482828/

Opus Genetics Phase 3 Trial for Phentolamine Ophthalmic ... In the study, 17.3% of patients treated with phentolamine ophthalmic solution 0.75% achieved a ≥15-letter Early Treatment Diabetic Retinopathy ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01703559

Study Details | NCT01703559 | The Safety and Efficacy of ... The Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution in Subjects With Severe Night Vision Disturbances. ClinicalTrials.gov ID NCT01703559.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36209072/

A randomized phase 2 clinical trial of phentolamine ... A randomized phase 2 clinical trial of phentolamine mesylate eye drops in patients with severe night vision disturbances.

8. ir.opusgtx.com ir.opusgtx.com/press-releases/detail/475/opus-genetics-announces-fda-fast-track-and-enrollment-updates-for-phentolamine-ophthalmic-solution-0-75-programs

Opus Genetics Announces FDA Fast Track and Enrollment ... The FDA has granted Fast Track designation for Phentolamine Ophthalmic Solution 0.75% as treatment of significant chronic night driving impairment.

9. ophthalmologyadvisor.com ophthalmologyadvisor.com/news/fda-fast-tracks-phentolamine-eyedrop-to-improve-night-vision-after-keratorefractive-surgery/

FDA Fast Tracks Phentolamine Eyedrop to Improve Night ... The FDA has granted Fast Track designation to phentolamine ophthalmic solution 0.75% for chronic night driving impairment.