Mesopic VisionPhase 3LYNX-2NCT06349759
Safety and Efficacy of 0.75% Phentolamine Ophthalmic Solution in Subjects With Post-refractive Surgery Visual Disturbances
A Phase 3 study testing phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist in people with Mesopic Vision and Night Vision Loss, run by Opus Genetics, Inc at 25 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mesopic Vision, Night Vision Loss
- What is being tested?
- phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 25 sitesUnited States
- Study dates
- 1 Apr 2024to 19 Feb 2026
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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
- Inclusion criteria #6, #7, and #8 must all be met in the same eye:
Show all 9Show fewer
- 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
Who cannot join
- Ophthalmic (in either eye):
- Prior unresolved dry eye diagnosis, taking prescription drops for dry eye, 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 28Show 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
- Pseudophakic subjects 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) 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 or herpes zoster keratitis at Screening). Subjects 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
- 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 (eg, chronic obstructive pulmonary disease or bronchial asthma; abnormally low BP or HR; second- or third-degree heart blockage or congestive heart failure; or severe diabetes as defined below)
- Predisposition to severe hypoglycemia (2 or more serious hypoglycemic episodes requiring assistance within 12 months prior to Screening)
- Any hospitalization or emergency room visit due to poor diabetic control within 6 months prior to Screening
- Currently untreated diabetes mellitus or previously untreated subjects who initiated oral anti-diabetic medication or insulin within 3 months prior to Screening
- Any sign of diabetic retinopathy in either eye
- Clinically significant systemic disease (eg, severe diabetes as previously defined, 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
- 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 (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 post-tubal ligation must have a negative urine pregnancy test result at each visit
- 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
25 sites in 1 country.
25 sites in 1 country
United States25 sites
United States
Bakersfield, California, 93309
United States Chattanooga
Chattanooga, Tennessee, 37411
United States Draper
Draper, Utah, 84020
United States Fargo
Fargo, North Dakota, 58103
United States
Fargo, North Dakota, 58103
United States Fraser
Fraser, Michigan, 48026
United States, North Carolina
Garner, North Carolina, 27529
United States, Glendale, CA
Glendale, California, 91204
United States, Jacksonville, FL
Jacksonville, Florida, 32256
United States Jacksonville
Jacksonville, Florida, 32257
United States, LaJolla, CA
La Jolla, California, 92903
United States Louisville
Louisville, Kentucky, 40206
United States Lynchburg
Lynchburg, Virginia, 24502
United States, Mt Pleasant, SC
Mt. Pleasant, South Carolina, 29464
United States
New York, New York, 10022
United States, California
Newport Beach, California, 92663
United States Overland Park
Overland Park, Kansas, 66210
United States Phoenix
Pheonix, Arizona, 85003
United States Rowland Heights
Rowland Heights, California, 91748
United States Scottsdale
Scottsdale, Arizona, 85260
United States Smithtown
Smithtown, New York, 11787
United States Smyrna
Smyrna, Tennessee, 37167
United States
Tampa, Florida, 33603
United States Torrance
Torrance, California, 90505
United States, Rhode Island
Warwick, Rhode Island, 02888
About this study
Official title: Randomized, Placebo-Controlled, Double-Masked Study of the Safety and Efficacy of POS (0.75% Phentolamine Ophthalmic Solution) in Subjects Who Have Previously Had Keratorefractive Surgery and Have Decreased Visual Acuity Under Mesopic Conditions
Safety and efficacy of 0.75% Phentolamine Ophthalmic Solution to improve mesopic low contrast visual acuity in subjects with post-refractive surgery visual disturbances.
Read the detailed description
Randomized, placebo-controlled, double-masked study of the safety and efficacy of POS (0.75% Phentolamine Ophthalmic Solution) in subjects who have previously had keratorefractive surgery and have decreased visual acuity (VA) under mesopic conditions
- Conditions
- Mesopic Vision, Night Vision Loss
- Being tested
- phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist, Placebo
- Keywords
- Low light vision
- Medical subject headings
- Vitamin A Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonistDrug
Also called Nyxol
Once daily dosing
PlaceboDrug
Also called phentolamine ophthalmic solution vehicle
Once daily dosing
| Study group | Role | What they receive |
|---|---|---|
| 0.75% phentolamine ophthalmic solution | Active comparator | Daily dosing Receives: Drug: phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist |
| phentolamine ophthalmic solution vehicle | Placebo comparator | Daily dosing Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With ≥ 15 Letters (3 Lines) Improvement in mLCVA in the Study Eye at Day 15 Compared to Baseline
This outcome measure will investigate the 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 in an effort to evaluate the efficacy of POS to improve mLCVA in subjects with post-refractive surgery visual disturbances.
Measured: 15 Days
Secondary outcomes (6)
Percentage of Subjects With ≥ 10 and ≥ 15 ETDRS Letters Improvement in mLCVA Compared to Baseline (Day 1 Pre-dose) at Days 3, 8, and 15 (≥ 10 ETDRS Letters Only) and Week 6
This outcome measure will investigate the percentage of subjects with ≥ 10 and ≥ 15 ETDRS letters improvement in mLCVA compared to baseline at Days 3, 8, and 15 (≥ 10 ETDRS letters only) and Week 6.
Measured: 6 Weeks
Mean and Change From Baseline in mLCVA at 0.5, 1, and 3 Hours Post-dose on Day 1
This outcome measure will investigate the mean and change from baseline in mLCVA at 0.5, 1, and 3 hours post-dose on Day 1.
Measured: 3 hours
Percentage of Subjects With ≥ 10 and ≥ 15 ETDRS Letters Improvement in Mesopic High-contrast Best-corrected Distance Visual Acuity (mHCVA) Compared to Baseline (Day 1 Pre-Dose) at Days 3, 8, and 15 and Week 6
This outcome measure will investigate the percentage of subjects with ≥ 10 and ≥ 15 ETDRS letters improvement in mesopic high-contrast best-corrected distance visual acuity (mHCVA) compared to baseline at Days 3, 8, and 15 and Week 6.
Measured: 6 Weeks
Mean and Change From Baseline (Day 1 Pre-dose) in mLCVA and mHCVA at Days 3, 8, and 15 and Week 6
This outcome measure will investigate the mean and change from baseline in mLCVA and mHCVA at Days 3, 8, and 15 and Week 6.
Measured: 6 Weeks
Mean and Change From Baseline (Day 1 Pre-dose) in PD at Days 3, 8, and 15 and Week 6
This outcome measure will investigate the mean and change from baseline in PD at Days 3, 8, and 15 and Week 6.
Measured: 6 Weeks
Change in Subject Questionnaire Responses Compared to Baseline (Day 1 Pre-dose) at Days 3, 8, and 15 and Week 6
This outcome measure will investigate the change in subject questionnaire responses compared to baseline at Days 3, 8, and 15 and Week 6. The Vision and Night Driving Questionnaire (VND-Q) is comprised of 9 questions related to visual difficulties when driving at night. Subjects were asked to assess, on a 1 (no difficulty) to 5 (extreme difficulty) scale, how much difficulty they had or would have with certain tasks while wearing their normal glasses or contact lenses (if any) for night driving.
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start1 Apr 2024
- Primary completion17 Apr 2025
- Study completion19 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mesopic VisionStudies 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Opus Genetics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Viatris Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06349759
- Sponsor's protocol ID
- OPI-NYXDLD-302 (LYNX-2)
- Acronym
- LYNX-2
- Status last verified
- Jul 2026
- First submitted
- 1 Apr 2024
- Last updated
- 26 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 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 Subjects Who Have Previously Had Keratorefractive Surgery and Have Decreased Visual Acuity Under Mesopic Conditions
- ClinicalTrials.gov ID
- NCT06349759
- Acronym / sponsor ID
- LYNX-2 / OPI-NYXDLD-302 (LYNX-2)
- Conditions
- Mesopic Vision, Night Vision Loss
- Keywords
- Low light vision
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Opus Genetics, IncIndustry (pharma, biotech, devices)
- Collaborators
- Viatris Inc.
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 17 Apr 2025 (actual)
- Study completion
- 19 Feb 2026 (actual)
- First posted
- 5 Apr 2024 (actual)
- Results
- Posted 18 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety and efficacy of 0.75% Phentolamine Ophthalmic Solution to improve mesopic low contrast visual acuity in subjects with post-refractive surgery visual disturbances.
Detailed description
Randomized, placebo-controlled, double-masked study of the safety and efficacy of POS (0.75% Phentolamine Ophthalmic Solution) in subjects who have previously had keratorefractive surgery and have decreased visual acuity (VA) 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 | Active comparator | Drug: phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonistDaily dosing |
| phentolamine ophthalmic solution vehicle | Placebo comparator | Drug: PlaceboDaily dosing |
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
- 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
Key exclusion criteria (28 listed)
- Prior unresolved dry eye diagnosis, taking prescription drops for dry eye, 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 |
|---|---|---|
| phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonistAlso: NyxolOnce daily dosing | Drug | 0.75% phentolamine ophthalmic solution |
| PlaceboAlso: phentolamine ophthalmic solution vehicleOnce daily dosing | Drug | phentolamine ophthalmic solution vehicle |
Primary outcome
Percentage of Subjects With ≥ 15 Letters (3 Lines) Improvement in mLCVA in the Study Eye at Day 15 Compared to Baseline
Time frame: 15 Days
This outcome measure will investigate the 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 in an effort to evaluate the efficacy of POS to improve mLCVA in subjects with post-refractive surgery visual disturbances.
6 secondary outcomes
Percentage of Subjects With ≥ 10 and ≥ 15 ETDRS Letters Improvement in mLCVA Compared to Baseline (Day 1 Pre-dose) at Days 3, 8, and 15 (≥ 10 ETDRS Letters Only) and Week 6
Time frame: 6 Weeks
Mean and Change From Baseline in mLCVA at 0.5, 1, and 3 Hours Post-dose on Day 1
Time frame: 3 hours
Percentage of Subjects With ≥ 10 and ≥ 15 ETDRS Letters Improvement in Mesopic High-contrast Best-corrected Distance Visual Acuity (mHCVA) Compared to Baseline (Day 1 Pre-Dose) at Days 3, 8, and 15 and Week 6
Time frame: 6 Weeks
Mean and Change From Baseline (Day 1 Pre-dose) in mLCVA and mHCVA at Days 3, 8, and 15 and Week 6
Time frame: 6 Weeks
Mean and Change From Baseline (Day 1 Pre-dose) in PD at Days 3, 8, and 15 and Week 6
Time frame: 6 Weeks
Change in Subject Questionnaire Responses Compared to Baseline (Day 1 Pre-dose) at Days 3, 8, and 15 and Week 6
Time frame: 6 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Mesopic Vision
RecruitingPhase 3
OPI-NXYDLD-303 Safety and Efficacy of Phentolamine Ophthalmic Solution in Keratorefractive Surgery Participants With Decreased Mesopic Visual Acuity
Vision Loss Night, Vision Disorders
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
25 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 phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist in people with Mesopic Vision and Night Vision Loss, run by Opus Genetics, Inc at 25 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 28 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: finished, as of the sponsor's last update on 26 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 25 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?
Yes. Results are posted in the registry (first posted 18 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects With ≥ 15 Letters (3 Lines) Improvement in mLCVA in the Study Eye at Day 15 Compared to Baseline (time frame: 15 Days). 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 26 Oct 2026.