Vision Loss NightPhase 3LYNX-3NCT07140783
OPI-NXYDLD-303 Safety and Efficacy of Phentolamine Ophthalmic Solution in Keratorefractive Surgery Participants With Decreased Mesopic Visual Acuity
A Phase 3 study testing 0.75% Phentolamine Ophthalmic Solution in people with Vision Loss Night and Vision Disorders, run by Opus Genetics, Inc at 20 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vision Loss Night, Vision Disorders
- What is being tested?
- 0.75% Phentolamine Ophthalmic Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 580 participants
- Where
- 20 sitesUnited States
- Study dates
- 2 Sep 2025to Aug 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females ≥ 18 years of age
- 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
- Inclusion criteria #5, #6, #7, and #8 must all be met in the same eye:
- History of keratorefractive surgery (eg, PRK, LASIK, SMILE, and RK/astigmatic keratotomy [AK]/limbal-relaxing incisions [LRI]) prior to 2010 in at least 1 eye and have participant reported night vision disturbances (eg, glare, halos, and/or starbursts). Symptoms must have been first noted within 2 months following keratorefractive surgery.
Show all 9Show fewer
- 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
Who cannot join
- Ophthalmic (in either eye unless otherwise noted):
- Prior unresolved dry eye diagnosis, taking prescription medication for dry eye (eg, drops, nasal sprays [Tyrvaya®], etc.), or taking artificial tear drops routinely for dry eye
- Prior history of fluctuating vision
- Clinically significant ocular disease as deemed by the Investigator (eg, untreated visually significant cataract, glaucoma, corneal edema, uveitis, severe keratoconjunctivitis sicca, retina degeneration, loss of visual field due to glaucoma or stroke, branch retinal vein occlusion, retina flare) that might interfere with the study
- History or presence of corneal endothelial dystrophy (eg, Fuchs' dystrophy or presence of guttae)
- Known hypersensitivity to any topical alpha-adrenoceptor antagonists
Show all 25Show fewer
- Known allergy or contraindication to any component of the vehicle formulation
- History of cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal in the study eye
- Pseudophakic participants with extended depth-of-focus or multifocal intraocular lenses (IOLs)
- Ocular trauma, ocular surgery (eg, IOLs), or laser procedure (eg, LASIK, PRK, SMILE, and RK/AK/LRI) within 6 months prior to Screening
- Use of any topical prescription or over-the-counter (OTC) ophthalmic medications of any kind (including artificial tear drops) within 7 days prior to Screening until study completion, with the exception of lid scrubs with OTC products (eg, OCuSOFT® lid scrub, SteriLid®, baby shampoo, etc.)
- Recent or current evidence of ocular infection or inflammation (such as current evidence of clinically significant blepharitis, conjunctivitis, or a history of herpes simplex keratitis or herpes zoster keratitis at Screening). Participants must be symptom free for at least 7 days prior to Screening
- History of diabetic retinopathy, diabetic macular edema, or dry or wet macular degeneration in the study eye
- History of any traumatic (surgical or nonsurgical) or nontraumatic condition affecting the pupil or iris (eg, irregularly shaped pupil, neurogenic pupil disorder, iris atrophy, iridotomy, iridectomy, etc.)
- Unwilling or unable to discontinue use of contact lenses at least 1 hour prior to Screening for soft contact lenses or at least 8 hours prior to Screening for hard gas-permeable contact lenses, and at least 8 hours (for both types of lenses) prior to all other office visits
- Previously undiagnosed dry eye, at the determination of the Investigator. Dry eye diagnosis should be based on one of the following dry eye test results: tear break-up time < 5 seconds, or corneal fluorescein staining ≥ Grade 2 in the inferior zone or ≥ Grade 1 in the central zone using the National Eye Institute scale
- Systemic:
- Known hypersensitivity or contraindication to alpha- and/or beta-adrenoceptor antagonists
- Clinically significant systemic disease (eg, severe diabetes, myasthenia gravis, cancer, hepatic, renal, endocrine, or cardiovascular disorders) that might interfere with the study
- Initiation of treatment with or any changes to the current dosage, drug, or regimen of any systemic adrenergic or cholinergic drugs within 7 days prior to Screening or during the study
- Participation in any investigational study within 30 days prior to Screening or during the study
- Participation in any other investigational study using POS
- Females of childbearing potential who are pregnant, nursing, planning a pregnancy during the study, or not using a medically acceptable form of birth control. Acceptable methods include the use of at least one of the following: intrauterine device, hormonal contraception (oral, injection, patch, implant, ring), barrier with spermicide (condom, diaphragm), or abstinence. A female is considered to be of childbearing potential unless she is 1 year postmenopausal or 3 months post-surgical sterilization. All females of childbearing potential, including those < 3 months post-tubal ligation, must have a negative urine pregnancy test result at Screening to enroll in the study
- Resting HR outside 50 to 110 beats per min at Screening. HR may be repeated only once if outside the specified range, following at least a 5-min rest period in the sitting position
- Hypertension with resting diastolic BP > 105 mmHg or systolic BP > 160 mmHg at Screening. BP may be repeated only once if outside the specified range, following at least a 5-min rest period in the sitting position
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
United States20 sites, 20 recruiting
- Recruiting
Arizona Eye Care
Chandler, Arizona, 85224
Erin Fox, 480-999-5458, erin.fox@doctrials.com
Michael Depenbusch, MD
- Recruiting
Scott & Christie EyeCare Associates
Cranberry Township, Pennsylvania, 16066
- Recruiting
Segal Drug Trials
Delray Beach, Florida, 33484
Charmi Gohil, 561-498-3664, charmi.research@gmail.com
Bruce Segal, MD
- Recruiting
Hoopes Vision
Draper, Utah, 84020
Shea Peterson, 801-988-7347, speterson@hoopesvision.com
Majid Moshirfar, md
- Recruiting
Oculus Research
Garner, North Carolina, 27529
Angel Garcia, 919-346-6945 ext. 104, angel.garcia@oculusresearch.com
Aune Carol, OD
- Recruiting
Global Research Management
Glendale, California, 91204
Logi El-Harazi, 818-246-2560, logi@grmclinical.com
Sherif El-Harazi, MD
- Recruiting
Zillan Clinical Research
Houston, Texas, 77082
Ike Abana, 310-404-3370, ik@zillanclinicalresearch.com
Emilike Agomo
- Recruiting
Gordon Schanzlin New Vision
La Jolla, California, 92037
Rylee Owen, rowen@gwsvision.com
Gordon Shanzlin, MD
- Recruiting
Eye Research Foundation
Newport Beach, California, 92663
Linda Wirta, 949-650-1863, linda.wirta@drwirta.com
David Wirta, MD
- Recruiting
Wyse Eyecare
Northbrook, Illinois, 60062
Maggie Sawa, 847- 497-2021, maggie@wyseyecare.com
Tamara Wyse, MD
- Recruiting
California Eye Specialists Medical Group
Pasadena, California, 91107
Kaci Taylor, 656-792-1074, ktayor@azulvision.com
Jay Patel, MD
- Recruiting
Eye Doctors of Arizona
Phoenix, Arizona, 85028
Charlsie Welch, 602-405-3424, charlsieresearch@eyedraz.com
Matthew Heller, DO
- Recruiting
Kannarr Eye Care
Pittsburg, Kansas, 66762
Megan Compton, 620-235-1737, mcompton@kannarreyecare.com
Shane Kannarr, OD
- Recruiting
Virdi Eye Clinic
Rock Island, Illinois, 61201
Mackensie Hook, 309-751-4847, mackensie@virdieyemd.com
Navaneet Borisuth, MD
- Recruiting
NVISION Clinical Research
San Diego, California, 92117
Christopher Bugawan, 949-866-4036, christopher.bugawan@nvisioncenters.com
Ellie Samadani
- Recruiting
Scripps Poway Eyecare and Optometry
San Diego, California, 92130
Leslie Shan, 858-530-2800, lshanod@gmail.com
Keith Wan, MD
- Recruiting
MRB Eye Care Consultants
Scottsdale, Arizona, 85254
Jill Froberg, 480-483-3937, jillfrobergsc@gmail.com
Marc Bloomenstein, OD
- Recruiting
Wolsten and Goldberg Eye Assoc.
Torrance, California, 90505
Cynthia Hernandez-Montes, 310-602-5640, cynthia@wgeye.com
Damien Goldberg, MD
- Recruiting
West Bay Eye Assoc.
Warwick, Rhode Island, 02888
George Patsiopoulos, 401-732-2350, drpatsiopoulos@westbayeye.com
Stephen Montaquila, OD
- Recruiting
Northeast Eye Research Associates
Woburn, Massachusetts, 01801
Deep Soni, 781-778-8559, deep@neeraeye.com
Ioanis Panagiotopoulos, OD
About this study
Official title: RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-MASKED STUDY OF THE SAFETY AND EFFICACY OF POS (0.75% PHENTOLAMINE OPHTHALMIC SOLUTION) IN PARTICIPANTS WITH PREVIOUS KERATOREFRACTIVE SURGERY WITH DECREASED VISUAL ACUITY UNDER MESOPIC CONDITIONS
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.
Read more
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
Read the detailed description
OPI-NXYDLD-303 RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-MASKED STUDY OF THE SAFETY AND EFFICACY OF POS (0.75% PHENTOLAMINE OPHTHALMIC SOLUTION) IN PARTICIPANTS WHO HAVE PREVIOUSLY HAD KERATOREFRACTIVE SURGERY AND HAVE DECREASED VISUAL ACUITY UNDER MESOPIC CONDITIONS
- Conditions
- Vision Loss Night, Vision Disorders
- Being tested
- 0.75% Phentolamine Ophthalmic Solution, Placebo
- Keywords
- keratorefractive surgery, decreased visual acuity, vision disorder, mesopic lighting, night vision
- Medical subject headings
- Vitamin A Deficiency, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.75% Phentolamine Ophthalmic SolutionDrug
Also called phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist
Once daily dosing
PlaceboDrug
Also called POS vehicle placebo
Once daily dosing
| Study group | Role | What they receive |
|---|---|---|
| 0.75% Phentolamine Ophthalmic Solution | Experimental | 0.75% Phentolamine Ophthalmic Solution Receives: Drug: 0.75% Phentolamine Ophthalmic Solution |
| Placebo - Phentolamine Ophthalmic Solution vehicle | Placebo comparator | Placebo-phentolamine ophthalmic solution vehicle Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
To evaluate the efficacy of POS to improve mLCVA in subjects with previous keratorefractive surgery
Measured: Day 15
Secondary outcomes (14)
Percentage of participants with ≥ 15 ETDRS letters (≥ 3 lines) improvement in the study eye in mLCVA compared to Baseline (Day 1 pre-dose) at Day 8
Measured: 8 Days
Mean change from Baseline in Vision and Night Driving Questionnaire (VND-Q) composite score (interval scale) at Day 15
Measured: 15 Days
Mean change from Baseline in VND-Q Item #4 (difficulty seeing the road because of oncoming headlights when driving at night) at Day 15
Measured: 15 Days
Mean change from Baseline in VND-Q Item #5 (difficulty seeing because of glare when driving at dawn or dusk) at Day 15
Measured: 15 Days
Mean change from Baseline in severity of halos at Day 15 on the Night-time Visual Disturbance Participant Questionnaire (NVDPQ)
Measured: 15 Days
Mean change from Baseline in severity of starbursts at Day 15 on the NVDPQ
Measured: 15 Days
Mean change from Baseline in overall severity of night-time visual disturbances at Day 15 on the NVDPQ
Measured: 15 Days
Mean change from Baseline in severity of glare at Day 15 on the NVDPQ
Measured: 15 Days
Mean and change from Baseline in study eye mLCVA at Day 15
Measured: 15 Days
Mean and change from Baseline in study eye mesopic PD at Day 15
Measured: 15 Days
Mean and change from Baseline (pre-dose) in study eye mLCVA at 0.5, 1, and 3 hours post dose on Day 1
Measured: 1 Day
Mean and change from Baseline (pre-dose) in study eye mesopic PD at 0.5, 1, and 3 hours post-dose on Day 1
Measured: 1 Day
Percentage of participants with ≥ 15 ETDRS letters improvement in study eye best corrected mHCVA compared to Baseline at Day 15
Measured: 15 Days
Mean and change from Baseline in study eye best corrected mHCVA at Day 15
Measured: 15 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start2 Sep 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vision Loss NightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 580 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Opus Genetics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140783
- Sponsor's protocol ID
- OPI-NYXDLD-303 (LYNX-3)
- Acronym
- LYNX-3
- Status last verified
- Oct 2026
- First submitted
- 22 Aug 2025
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-MASKED STUDY OF THE SAFETY AND EFFICACY OF POS (0.75% PHENTOLAMINE OPHTHALMIC SOLUTION) IN PARTICIPANTS WITH PREVIOUS KERATOREFRACTIVE SURGERY WITH DECREASED VISUAL ACUITY UNDER MESOPIC CONDITIONS
- ClinicalTrials.gov ID
- NCT07140783
- Acronym / sponsor ID
- LYNX-3 / OPI-NYXDLD-303 (LYNX-3)
- Conditions
- Vision Loss Night, Vision Disorders
- Keywords
- keratorefractive surgery, decreased visual acuity, vision disorder, mesopic lighting, night vision
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 580 participants (estimated)
- Lead sponsor
- Opus Genetics, IncIndustry (pharma, biotech, devices)
- Study start
- 2 Sep 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 26 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
OPI-NXYDLD-303 RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-MASKED STUDY OF THE SAFETY AND EFFICACY OF POS (0.75% PHENTOLAMINE OPHTHALMIC SOLUTION) IN PARTICIPANTS WHO HAVE PREVIOUSLY HAD KERATOREFRACTIVE SURGERY AND HAVE DECREASED VISUAL ACUITY UNDER MESOPIC CONDITIONS
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.75% Phentolamine Ophthalmic Solution | Experimental | Drug: 0.75% Phentolamine Ophthalmic Solution0.75% Phentolamine Ophthalmic Solution |
| Placebo - Phentolamine Ophthalmic Solution vehicle | Placebo comparator | Drug: PlaceboPlacebo-phentolamine ophthalmic solution vehicle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males or females ≥ 18 years of age
- 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
- History of keratorefractive surgery (eg, PRK, LASIK, SMILE, and RK/astigmatic keratotomy [AK]/limbal-relaxing incisions [LRI]) prior to 2010 in at least 1 eye and have participant reported night vision disturbances (eg, glare, halos, and/or starbursts). Symptoms must have been first noted within 2 months following keratorefractive surgery.
Key exclusion criteria (25 listed)
- Prior unresolved dry eye diagnosis, taking prescription medication for dry eye (eg, drops, nasal sprays [Tyrvaya®], etc.), or taking artificial tear drops routinely for dry eye
- Prior history of fluctuating vision
- Clinically significant ocular disease as deemed by the Investigator (eg, untreated visually significant cataract, glaucoma, corneal edema, uveitis, severe keratoconjunctivitis sicca, retina degeneration, loss of visual field due to glaucoma or stroke, branch retinal vein occlusion, retina flare) that might interfere with the study
- History or presence of corneal endothelial dystrophy (eg, Fuchs' dystrophy or presence of guttae)
- Known hypersensitivity to any topical alpha-adrenoceptor antagonists
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.75% Phentolamine Ophthalmic SolutionAlso: phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonistOnce daily dosing | Drug | 0.75% Phentolamine Ophthalmic Solution |
| PlaceboAlso: POS vehicle placeboOnce daily dosing | Drug | Placebo - Phentolamine Ophthalmic Solution vehicle |
Primary outcome
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
To evaluate the efficacy of POS to improve mLCVA in subjects with previous keratorefractive surgery
14 secondary outcomes
Percentage of participants with ≥ 15 ETDRS letters (≥ 3 lines) improvement in the study eye in mLCVA compared to Baseline (Day 1 pre-dose) at Day 8
Time frame: 8 Days
Mean change from Baseline in Vision and Night Driving Questionnaire (VND-Q) composite score (interval scale) at Day 15
Time frame: 15 Days
Mean change from Baseline in VND-Q Item #4 (difficulty seeing the road because of oncoming headlights when driving at night) at Day 15
Time frame: 15 Days
Mean change from Baseline in VND-Q Item #5 (difficulty seeing because of glare when driving at dawn or dusk) at Day 15
Time frame: 15 Days
Mean change from Baseline in severity of halos at Day 15 on the Night-time Visual Disturbance Participant Questionnaire (NVDPQ)
Time frame: 15 Days
Mean change from Baseline in severity of starbursts at Day 15 on the NVDPQ
Time frame: 15 Days
Mean change from Baseline in overall severity of night-time visual disturbances at Day 15 on the NVDPQ
Time frame: 15 Days
Mean change from Baseline in severity of glare at Day 15 on the NVDPQ
Time frame: 15 Days
Mean and change from Baseline in study eye mLCVA at Day 15
Time frame: 15 Days
Mean and change from Baseline in study eye mesopic PD at Day 15
Time frame: 15 Days
Mean and change from Baseline (pre-dose) in study eye mLCVA at 0.5, 1, and 3 hours post dose on Day 1
Time frame: 1 Day
Mean and change from Baseline (pre-dose) in study eye mesopic PD at 0.5, 1, and 3 hours post-dose on Day 1
Time frame: 1 Day
Percentage of participants with ≥ 15 ETDRS letters improvement in study eye best corrected mHCVA compared to Baseline at Day 15
Time frame: 15 Days
Mean and change from Baseline in study eye best corrected mHCVA at Day 15
Time frame: 15 Days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Vision Loss Night
Active, not recruitingPhase 1/2
Study to Assess the Safety and Efficacy of OCU400 for Retinitis Pigmentosa and Leber Congenital Amaurosis
Retinitis Pigmentosa, Leber Congenital Amaurosis
Recruiting
Stem Cell Ophthalmology Treatment Study II
Retinal Disease, Age-Related Macular Degeneration
RecruitingObservational study
Inherited Retinal Degenerative Disease Registry
Eye Diseases Hereditary, Retinal Disease
Active, not recruitingObservational study
Natural History Study in Patients With PDE6A-, PDE6B- and RHO-linked Retinitis Pigmentosa
Retinitis Pigmentosa
RecruitingPhase 1/2
GVB-2001 Gene Therapy Via Intracameral Injection for the Treatment of Primary Open Angle Glaucoma
Primary Open-Angle Glaucoma (POAG)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 0.75% Phentolamine Ophthalmic Solution in people with Vision Loss Night and Vision Disorders, run by Opus Genetics, Inc at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Director (984-884-6030, ct.gov_inquiries@opusgtx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.