Dim Light Vision DisturbancesPhase 3NCT04638660
Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) in Subjects With Dim Light Vision Disturbances
A Phase 3 study testing Phentolamine Ophthalmic Solution 0.75% in people with Dim Light Vision Disturbances, run by Opus Genetics, Inc at 17 sites in United States.
Trial summary
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 Disturbances (DLD) To evaluate efficacy of Nyxol to improve visual performance To evaluate the safety of Nyxol Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dim Light Vision Disturbances
- What is being tested?
- Phentolamine Ophthalmic Solution 0.75%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 17 sitesUnited States
- Study dates
- 30 Dec 2020to 19 May 2022
- 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
- Subject-reported DLD (likely subjects with a history of multifocal IOLs, post-laser-assisted in situ keratomileusis [LASIK], corneal scars, and keratoconus)
- Ability to comply with all protocol-mandated procedures independently and to attend all
- Otherwise healthy and well-controlled subjects
- Able and willing to give written consent to participate in this study
- Able to self-administer study medication
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- PD ≥ 6 mm under mesopic conditions (prior to illumination) in at least one eye
- ≤ 20 (20/100 Snellen or worse) ETDRS letters in mLCVA score
- ≥10 ETDRS letters ( ≥2 lines) improvement in mLCVA in at least one eye during illumination of the contralateral eye with a BAT system on low setting
Who cannot join
- Ophthalmic:
- Prior history of dry eye diagnosis, taking prescription drops for dry eye, or taking artificial tear drops occasionally for dry eye
- Prior history of fluctuating vision
- Clinically significant ocular disease as deemed by the Investigator that might interfere with the study
- Known hypersensitivity to any topical alpha-adrenoceptor antagonists
- Known allergy or contraindication to any component of the vehicle formulation
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- History of cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal
- Ocular trauma, ocular surgery (e.g., IOLs) or laser procedure (e.g., LASIK, photorefractive keratectomy [PRK]) within 6 months prior to screening
- Use of any topical prescription or over-the-counter (OTC) ophthalmic medications of any kind within 7 days of screening
- Recent or current evidence of ocular infection or inflammation in either eye. Subjects must be symptom free for at least 7 days.
- 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
- Unwilling or unable to discontinue use of contact lenses at screening until study completion, except for keratoconus subjects who may wear contacts up to 24 hours prior to their scheduled visits
- Systemic:
- Known hypersensitivity or contraindication to alpha- and/or beta-adrenoceptor antagonists
- Clinically significant systemic disease 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 and during the conduct of the study
- Females of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control
- Resting HR outside the specified range (50-110 beats per minute)
- Hypertension with resting diastolic BP > 105 mmHg or systolic BP > 160 mmHg
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Clinical Site 20
Edgewood, Kentucky, 41017
Clinical Site 4
Elizabeth City, North Carolina, 27909
Clinical Site 2
Fargo, North Dakota, 58103
Clinical Site 22
High Point, North Carolina, 27262
Clinical Site 9
High Point, North Carolina, 27262
Clinical Site 3
Jacksonville, Florida, 32204
Clinical Site 18
Jacksonville, Florida, 32256
Clinical Site 14
Louisville, Kentucky, 41008
Clinical Site 11
Memphis, Tennessee, 38119
Clinical Site 6
Newport Beach, California, 92663
Clinical Site 19
Ogden, Utah, 84403
Clinical Site 10
Palisades Park, New Jersey, 07650
Clinical Site 8
Pennington, New Jersey, 08534
Clinical Site 1
Petaluma, California, 94954
Clinical Site 13
Pittsburg, Kansas, 66762
Clinical Site 5
San Antonio, Texas, 78240
Clinical Test 15
Warwick, Rhode Island, 57108
About this study
Official title: Randomized, Placebo-Controlled, Double-Masked Study of the Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) in Subjects With Dim Light Vision Disturbances
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 Disturbances (DLD)
- To evaluate efficacy of Nyxol to improve visual performance
- To evaluate the safety of Nyxol
Read the detailed description
Placebo-controlled, double-masked, multiple-dose, Phase 3 study in approximately 160 randomized subjects with DLD (approximately 136 that are evaluable for efficacy), evaluating safety and efficacy of Nyxol in subjects with DLD following administration of Nyxol once daily (QD) at or near bedtime (at 8PM to 10PM) in both eyes (OU) for 14 days.
Following the successful completion of screening, each subject will be stratified by iris color (light/dark irides) and will then be randomized to treatment (masked) 1:1, Nyxol or placebo (vehicle).
Treatment (Nyxol or placebo) will be administered in both eyes (OU) by the subjects at or near bedtime each day.
At the first visit subjects will be screened for study eligibility.
Treatment visits will occur 2 times: Day 8 (+1 day)/Visit 2 and Day 15 (+1 day)/Visit 3. mLCVA evaluations shall be performed on each of these days.
A follow-up visit (Visit 4) phone call will occur 1 to 3 days after Visit 3.
At select sites OPD Scan measurements will be made using wavefront abhermettry.
- Conditions
- Dim Light Vision Disturbances
- Being tested
- Phentolamine Ophthalmic Solution 0.75%, Phentolamine Ophthalmic Solution Vehicle (Placebo)
- Keywords
- Nyxol, Night Vision Disturbances, Glare, Halos, Starbursts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phentolamine Ophthalmic Solution 0.75%Drug
Also called Nyxol, Nyxol®
0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
Phentolamine Ophthalmic Solution Vehicle (Placebo)Drug
Topical sterile ophthalmic solution
| Study group | Role | What they receive |
|---|---|---|
| Phentolamine Ophthalmic Solution 0.75% | Experimental | One drop in both eyes at or near bedtime (8PM to 10PM) Receives: Drug: Phentolamine Ophthalmic Solution 0.75% |
| Phentolamine Ophthalmic Solution Vehicle | Placebo comparator | One drop in both eyes at or near bedtime (8PM to 10PM) Receives: Drug: Phentolamine Ophthalmic Solution Vehicle (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Subjects With 3 Lines mLCVA Improvement in Study Eye
Percent of subjects with ≥ 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (≥3 lines) of improvement in the study eye compared to baseline in monocular mLCVA at Day 8
Measured: 8 days
Secondary outcomes (4)
Percent of Subjects With mLCVA Improvement in Study Eye
Percent of subjects with ≥ 5, ≥ 10, and ≥ 15 ETDRS letters (≥ 1, ≥ 2, and ≥ 3 lines, respectively) improvement compared to baseline in mLCVA at Day 8 (excluding the primary endpoint)
Measured: up to 15 days
Percent of Subjects With Photopic Low Contrast Visual Acuity (pLCVA) and mHCVA Improvement in Study Eye
Percent of subjects with ≥ 5, ≥ 10, and ≥ 15 ETDRS letters (≥ 1, ≥ 2, and ≥ 3 lines, respectively) improvement compared to baseline in pLCVA and mHCVA at Day 8 and Day 15
Measured: up to 15 days
Change From Baseline in Study Eye Mesopic Pupil Diameter (PD)
Change from baseline in study eye mesopic PD
Measured: up to 15 days
Percent Change From Baseline in Study Eye Mesopic Pupil Diameter (PD)
Percent change from baseline in study eye mesopic PD
Measured: up to 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start30 Dec 2020
- Primary completion19 May 2022
- Study completion19 May 2022
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 Dim Light Vision DisturbancesStudies 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
- Model description
- All subjects will be randomized into the study in a 1:1 ratio to one of the treatment arms (Nyxol or placebo), with a stratification by light/dark irides.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Opus Genetics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04638660
- Sponsor's protocol ID
- OPI-NYXDLD-301 (LYNX-1)
- Status last verified
- Aug 2023
- First submitted
- 16 Nov 2020
- Last updated
- 30 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 30 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 Nyxol (0.75% Phentolamine Ophthalmic Solution) in Subjects With Dim Light Vision Disturbances
- ClinicalTrials.gov ID
- NCT04638660
- Acronym / sponsor ID
- OPI-NYXDLD-301 (LYNX-1)
- Conditions
- Dim Light Vision Disturbances
- Keywords
- Nyxol, Night Vision Disturbances, Glare, Halos, Starbursts
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Opus Genetics, IncIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2020 (actual)
- Primary completion
- 19 May 2022 (actual)
- Study completion
- 19 May 2022 (actual)
- First posted
- 20 Nov 2020 (actual)
- Results
- Posted 9 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 Disturbances (DLD)
- To evaluate efficacy of Nyxol to improve visual performance
- To evaluate the safety of Nyxol
Detailed description
Placebo-controlled, double-masked, multiple-dose, Phase 3 study in approximately 160 randomized subjects with DLD (approximately 136 that are evaluable for efficacy), evaluating safety and efficacy of Nyxol in subjects with DLD following administration of Nyxol once daily (QD) at or near bedtime (at 8PM to 10PM) in both eyes (OU) for 14 days.
Following the successful completion of screening, each subject will be stratified by iris color (light/dark irides) and will then be randomized to treatment (masked) 1:1, Nyxol or placebo (vehicle).
Treatment (Nyxol or placebo) will be administered in both eyes (OU) by the subjects at or near bedtime each day.
At the first visit subjects will be screened for study eligibility.
Treatment visits will occur 2 times: Day 8 (+1 day)/Visit 2 and Day 15 (+1 day)/Visit 3. mLCVA evaluations shall be performed on each of these days.
A follow-up visit (Visit 4) phone call will occur 1 to 3 days after Visit 3.
At select sites OPD Scan measurements will be made using wavefront abhermettry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- All subjects will be randomized into the study in a 1:1 ratio to one of the treatment arms (Nyxol or placebo), with a stratification by light/dark irides.
| Arm | Type | Receives |
|---|---|---|
| Phentolamine Ophthalmic Solution 0.75% | Experimental | Drug: Phentolamine Ophthalmic Solution 0.75%One drop in both eyes at or near bedtime (8PM to 10PM) |
| Phentolamine Ophthalmic Solution Vehicle | Placebo comparator | Drug: Phentolamine Ophthalmic Solution Vehicle (Placebo)One drop in both eyes at or near bedtime (8PM to 10PM) |
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
- Subject-reported DLD (likely subjects with a history of multifocal IOLs, post-laser-assisted in situ keratomileusis [LASIK], corneal scars, and keratoconus)
- Ability to comply with all protocol-mandated procedures independently and to attend all
- Otherwise healthy and well-controlled subjects
- Able and willing to give written consent to participate in this study
Key exclusion criteria (21 listed)
- Prior history of dry eye diagnosis, taking prescription drops for dry eye, or taking artificial tear drops occasionally for dry eye
- Prior history of fluctuating vision
- Clinically significant ocular disease as deemed by the Investigator that might interfere with the study
- Known hypersensitivity to any topical alpha-adrenoceptor antagonists
- Known allergy or contraindication to any component of the vehicle formulation
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%Also: Nyxol, Nyxol®0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist | Drug | Phentolamine Ophthalmic Solution 0.75% |
| Phentolamine Ophthalmic Solution Vehicle (Placebo)Topical sterile ophthalmic solution | Drug | Phentolamine Ophthalmic Solution Vehicle |
Primary outcome
Percent of Subjects With 3 Lines mLCVA Improvement in Study Eye
Time frame: 8 days
Percent of subjects with ≥ 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (≥3 lines) of improvement in the study eye compared to baseline in monocular mLCVA at Day 8
4 secondary outcomes
Percent of Subjects With mLCVA Improvement in Study Eye
Time frame: up to 15 days
Percent of Subjects With Photopic Low Contrast Visual Acuity (pLCVA) and mHCVA Improvement in Study Eye
Time frame: up to 15 days
Change From Baseline in Study Eye Mesopic Pupil Diameter (PD)
Time frame: up to 15 days
Percent Change From Baseline in Study Eye Mesopic Pupil Diameter (PD)
Time frame: up to 15 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
17 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% in people with Dim Light Vision Disturbances, run by Opus Genetics, Inc at 17 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 21 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 30 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 17 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 9 Aug 2023). 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?
Percent of Subjects With 3 Lines mLCVA Improvement in Study Eye (time frame: 8 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 30 Oct 2026.