CompletedPhase 3

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

United States200 participantsStarted 2024-04-01

Plain-language summary

Safety and efficacy of 0.75% Phentolamine Ophthalmic Solution to improve mesopic low contrast visual acuity in subjects with post-refractive surgery visual disturbances.

Who can participate

Age range

18 Years

Sex

ALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Males or females ≥ 18 years of age
. Previous history of refractive surgery (eg, PRK, LASIK, SMILE, and RK) and have subject-reported night vision disturbances (eg, glare, halos, and/or starbursts). Symptoms must have been first noted within 2 months following refractive surgery
. Able to independently comply with all protocol-mandated procedures and to attend all scheduled office visits
. Able and willing to give written consent to participate in this study
. Able to self-administer study medication
. PD ≥ 5 mm under mesopic conditions in at least 1 eye. This test may be repeated once, following an additional 5 min of dark adaptation to the mesopic light conditions if the initial results do not meet this criterion
. mLCVA ≤ 30 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (20/63 Snellen or worse) in at least 1 eye using the Precision Vision Illuminator Cabinet with 5% translucent contrast chart and a mesopic filter at 4 m
. ≥ 10 ETDRS letters improvement in mLCVA in at least 1 eye during illumination of the contralateral eye with a Brightness Acuity Tester (BAT) system on the low setting using the Precision Vision Illuminator Cabinet with 5% translucent contrast chart and a mesopic filter at 4 m

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Day 15

Trial details

NCT IDNCT06349759

SponsorOcuphire Pharma, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-04-17

View on ClinicalTrials.gov More Mesopic Vision trials