Decrease in Night VisionPhase 2SNVNCT04004507
Single Dose Study of Phentolamine Mesylate Eye Drops in Patients With Severe Night Vision Disturbances
A Phase 2 study testing Phentolamine Mesylate Ophthalmic Solution 1% in people with Decrease in Night Vision and Disturbance; Vision, Loss, run by Opus Genetics, Inc at 1 site in United States.
Trial summary
The objectives of this study are: To assess the effect of ophthalmic phentolamine mesylate in mesopic conditions on the four endpoints: 1. Contrast sensitivity 2. Low contrast visual acuity 3. Wavefront aberrometry 4. Subjective questionnaire To assess the safety of ophthalmic phentolamine mesylate Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Decrease in Night Vision, Disturbance; Vision, Loss
- What is being tested?
- Phentolamine Mesylate Ophthalmic Solution 1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Feb 2008
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients ≥ 18 years of age
- Currently experiencing severe night vision difficulty as reported subjectively
- At least two patches below the normal range at any two frequencies in Contrast Sensitivity done under mesopic conditions with glare
- Improvement in low contrast visual acuity (LCVA) in dim light during illumination of contralateral eye
- Good general health
- Written informed consent to participate in this trial
- Ability to comply with all protocol mandated procedures and to attend all scheduled office visits
Who cannot join
- Patients with untreated cataracts grades 1-4
- Patients who wear contact lenses
- Less than 5 weeks post-refractive surgery (LASIK or PRK)
- Less than 5 weeks post intraocular lens insertion
- Low blood pressure (systolic <120 mm Hg or diastolic <80 mm Hg)
- A history of heart rate abnormalities
Show all 11Show fewer
- Administration of any investigational drug within 30 days of study initiation
- Use of any eye drops with a pharmacologic effect on the pupil within 7 days of Visit 1
- Use of any systemic alpha adrenergic antagonists (Appendix 1)
- Known local or systemic hypersensitivity to adrenergic antagonists
- For women of childbearing potential: currently pregnant or lactating, or unwilling to use birth control during the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Ophthalmic Consultants of Long Island, NY
Lynbrook, New York, 11563
About this study
The objectives of this study are:
- To assess the effect of ophthalmic phentolamine mesylate in mesopic conditions on the four endpoints:
- Contrast sensitivity
- Low contrast visual acuity
- Wavefront aberrometry
- Subjective questionnaire
- To assess the safety of ophthalmic phentolamine mesylate
Read the detailed description
Double-masked, placebo-controlled, single-dose Phase 2 study in 24 patients experiencing severe night vision difficulties to evaluate ocular and systemic safety and efficacy following administration of one drop of phentolamine mesylate 1.0% QD in each eye for 1 day.
- Being tested
- Phentolamine Mesylate Ophthalmic Solution 1%, Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)
- Keywords
- Night Vision Disturbances, NVD, Glare, Halos, Starbursts, Nyxol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phentolamine Mesylate Ophthalmic Solution 1%Drug
Topical Sterile Ophthalmic Solution
Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)Other
Topical Sterile Ophthalmic Solution
| Study group | Role | What they receive |
|---|---|---|
| Phentolamine Mesylate Ophthalmic Solution 1% | Experimental | 1 drop in each eye (QD) for one day. Receives: Drug: Phentolamine Mesylate Ophthalmic Solution 1% |
| Phentolamine Mesylate Ophthalmic Solution Vehicle | Placebo comparator | 1 drop in each eye (QD) for one day. Receives: Other: Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast Sensitivity
Average change in monocular contrast sensitivity scores under mesopic conditions at each of five spatial frequencies with and without glare.
The tests were performed in a darkened room using the Optec 6500 instrument (Stereo Optical) using Slides 5-9 (spatial frequencies 1.5 - 18 cycles per degree), with the distance setting at "far", and with the light setting at "night". Subjects were asked to read each slide from left to right indicating if the lines were tilted to the left, the right or straight up and down until they provided 2 consecutive incorrect responses. The total number of correct responses for each slide was recorded.
Measured: 1 day
Secondary outcomes (3)
Visual Acuity
Average number of letters of improvement in the following parameters:
- Distance high-contrast visual acuity under mesopic conditions (monocular, measured at 4 meters)
- Distance high-contrast visual acuity under photopic conditions (monocular, measured at 4 meters)
- Distance low-contrast visual acuity under mesopic conditions (monocular, measured at 4 meters)
- Distance low-contrast visual acuity under photopic conditions (monocular, measured at 4 meters)
Measured: 1 day
Self-Reported Vision Quality
Subjective patient evaluations of vision quality at night (% rating their vision as improved)
Measured: 1 day
Pupil Diameter
Average change in pupil diameter
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study startAug 2007
- Primary completionOct 2007
- Study completionFeb 2008
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Decrease in Night 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Opus Genetics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ophthalmic Consultants of Long Island
- Responsible party
- Sponsor
- Investigators
- Marguerite McDonald, MD, FACS, Principal investigator, Ophthalmic Consultants of Long Island, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04004507
- Sponsor's protocol ID
- NYX-SNV
- Acronym
- SNV
- Status last verified
- May 2022
- First submitted
- 28 Jun 2019
- Last updated
- 30 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Pepose J, Brigell M, Lazar E, Heisel C, Yousif J, Rahmani K, Kolli A, Hwang M, Mitrano C, Lazar A, Charizanis K, Sooch M, McDonald M. A randomized phase 2 clinical trial of phentolamine mesylate eye drops in patients with severe night vision disturbances. BMC Ophthalmol. 2022 Oct 8;22(1):402. doi: 10.1186/s12886-022-02621-6.
PubMed 36209072
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
- Single Dose Study of Phentolamine Mesylate Eye Drops in Patients With Severe Night Vision Disturbances
- ClinicalTrials.gov ID
- NCT04004507
- Acronym / sponsor ID
- SNV / NYX-SNV
- Keywords
- Night Vision Disturbances, NVD, Glare, Halos, Starbursts, Nyxol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Opus Genetics, IncIndustry (pharma, biotech, devices)
- Collaborators
- Ophthalmic Consultants of Long Island
- Study start
- Aug 2007 (actual)
- Primary completion
- Oct 2007 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 2 Jul 2019 (actual)
- Results
- Posted 15 Feb 2024
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 assess the effect of ophthalmic phentolamine mesylate in mesopic conditions on the four endpoints:
- Contrast sensitivity
- Low contrast visual acuity
- Wavefront aberrometry
- Subjective questionnaire
- To assess the safety of ophthalmic phentolamine mesylate
Detailed description
Double-masked, placebo-controlled, single-dose Phase 2 study in 24 patients experiencing severe night vision difficulties to evaluate ocular and systemic safety and efficacy following administration of one drop of phentolamine mesylate 1.0% QD in each eye for 1 day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phentolamine Mesylate Ophthalmic Solution 1% | Experimental | Drug: Phentolamine Mesylate Ophthalmic Solution 1%1 drop in each eye (QD) for one day. |
| Phentolamine Mesylate Ophthalmic Solution Vehicle | Placebo comparator | Other: Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)1 drop in each eye (QD) for one day. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female patients ≥ 18 years of age
- Currently experiencing severe night vision difficulty as reported subjectively
- At least two patches below the normal range at any two frequencies in Contrast Sensitivity done under mesopic conditions with glare
- Improvement in low contrast visual acuity (LCVA) in dim light during illumination of contralateral eye
- Good general health
Key exclusion criteria (11 listed)
- Patients with untreated cataracts grades 1-4
- Patients who wear contact lenses
- Less than 5 weeks post-refractive surgery (LASIK or PRK)
- Less than 5 weeks post intraocular lens insertion
- Low blood pressure (systolic <120 mm Hg or diastolic <80 mm Hg)
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 Mesylate Ophthalmic Solution 1%Topical Sterile Ophthalmic Solution | Drug | Phentolamine Mesylate Ophthalmic Solution 1% |
| Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)Topical Sterile Ophthalmic Solution | Other | Phentolamine Mesylate Ophthalmic Solution Vehicle |
Primary outcome
Contrast Sensitivity
Time frame: 1 day
Average change in monocular contrast sensitivity scores under mesopic conditions at each of five spatial frequencies with and without glare. The tests were performed in a darkened room using the Optec 6500 instrument (Stereo Optical) using Slides 5-9 (spatial frequencies 1.5 - 18 cycles per degree), with the distance setting at "far", and with the light setting at "night". Subjects were asked to read each slide from left to right indicating if the lines were tilted to the left, the right or straight up and down until they provided 2 consecutive incorrect responses. The total number of correct responses for each slide was recorded.
3 secondary outcomes
Visual Acuity
Time frame: 1 day
Self-Reported Vision Quality
Time frame: 1 day
Pupil Diameter
Time frame: 1 day
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.
- Derived from this study: PubMed 36209072Pepose J, Brigell M, Lazar E, Heisel C, Yousif J, Rahmani K, Kolli A, Hwang M, Mitrano C, Lazar A, Charizanis K, Sooch M, McDonald M. A randomized phase 2 clinical trial of phentolamine mesylate eye drops in patients with severe night vision disturbances. BMC Ophthalmol. 2022 Oct 8;22(1):402. doi: 10.1186/s12886-022-02621-6.
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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.
Marguerite McDonald, MD, FACS principal investigator
Ophthalmic Consultants of Long Island, NY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Phentolamine Mesylate Ophthalmic Solution 1% in people with Decrease in Night Vision and Disturbance; Vision, Loss, run by Opus Genetics, Inc at 1 site 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 7 inclusion and 11 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 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 15 Feb 2024). 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?
Contrast Sensitivity (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04004507, which also lists 1 linked publication.
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.