Open Angle GlaucomaPhase 2NCT03960866
Safety and Efficacy of Ophthalmic Phentolamine Mesylate in Glaucoma
A Phase 2 study testing Phentolamine Mesylate Ophthalmic Solution 1% in people with Open Angle Glaucoma and Ocular Hypertension, run by Opus Genetics, Inc at 5 sites in United States.
Trial summary
The objectives of this study are: To evaluate the efficacy of Phentolamine Mesylate to lower intra-ocular pressure (IOP) in the treatment of Open-Angle Glaucoma (OAG) and Ocular Hypertension (OHT). To evaluate the ocular and systemic safety of Phentolamine Mesylate compared to its vehicle. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Angle Glaucoma, Ocular Hypertension
- What is being tested?
- Phentolamine Mesylate Ophthalmic Solution 1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 5 sitesUnited States
- Study dates
- 28 May 2019to 11 Sep 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or greater
- Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT). A reported history of untreated OHT with IOP ≥22mmHg and ≤ 30mmHg is preferred.
- Untreated or treated OAG/OHT with 2 or fewer ocular hypotensive medications.
- Untreated (post-washout) mean IOP ≥ 22mmHg and ≤30mmHg in the study eye at the Qualification Visit (8AM).
- Corrected visual acuity in each eye +1.0 logMAR or better by Early Treatment Diabetic Retinopathy Study (ETDRS) in each eye (equivalent to 20/200 or better) at the Screening Visit and Qualification Visit.
- Otherwise healthy and well-controlled subjects.
- Able and willing to give signed informed consent and follow study instructions.
- Able to self-administer study medication or to have study medication administered by a caregiver throughout the study period.
Who cannot join
- Closed or very narrow angles (Grade 0-1, Shaffer)
- Glaucoma: pseudo-exfoliation or pigment dispersion component
- Known hypersensitivity to any α-adrenoceptor antagonists
- Previous laser and/or non-laser glaucoma surgery or procedure in either eye
- Refractive surgery in either eye
- Ocular trauma in either eye within the 6 months prior to Screening, or ocular surgery or non-refractive laser treatment within the 3 months prior to Screening
Show all 21Show fewer
- Recent or current evidence of ocular infection or inflammation in either eye
- Ocular medication in either eye of any kind within 30 days of Screening
- Clinically significant ocular disease in either eye
- History of diabetic retinopathy
- Contact lens wear within 3 days prior to and for the duration of the study
- Central corneal thickness in either eye >600 μm at Screening
- Any abnormality in either eye preventing reliable applanation tonometry
- Known hypersensitivity or contraindication to α- and/or β-adrenoceptor antagonists
- Clinically significant systemic disease that might interfere with the study
- Participation in any investigational study within 30 days prior to Screening
- Use of any topical or systemic adrenergic or cholinergic drugs up to 30 days prior to Screening, or during the study
- Changes in systemic medication that could have an effect on IOP within 30 days prior to Screening
- Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control
- Resting heart rate outside the normal range (50-110 beats per minute) at Screening or Qualification Visit
- Hypertension with resting diastolic blood pressure (BP) > 105 mmHg or systolic BP > 160 mmHg at the Screening or Qualification Visit
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Michigan Kellogg Eye Center
Ann Arbor, Michigan, 48105
Abrams Eye Center
Cleveland, Ohio, 44115
North Valley Eye Medical Group
Mission Hills, California, 91345
Clayton Eye Clinical Research
Morrow, Georgia, 30260
Rochester Ophthalmological Group
Rochester, New York, 14618
About this study
Official title: Randomized, Placebo-Controlled, Double-Masked Study of the Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution in Subjects With Open Angle Glaucoma or Ocular Hypertension
The objectives of this study are:
- To evaluate the efficacy of Phentolamine Mesylate to lower intra-ocular pressure (IOP) in the treatment of Open-Angle Glaucoma (OAG) and Ocular Hypertension (OHT).
- To evaluate the ocular and systemic safety of Phentolamine Mesylate compared to its vehicle.
- To evaluate additional efficacy of Phentolamine Mesylate to improve visual performance.
Read the detailed description
Placebo-controlled double-masked, multiple dose Phase 2 study in 40 patients with IOP ≥ 22 and ≤30 mmHg, evaluating ocular and systemic safety and efficacy following administration of Phentolamine mesylate 1.0% QD at 8PM to 10PM in both eyes for 14 days.
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Being tested
- Phentolamine Mesylate Ophthalmic Solution 1%, Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)
- Keywords
- Open Angle Glaucoma, Ocular Hypertension
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
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
Also called Nyxol®
Topical Sterile Ophthalmic Solution
Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)Other
Topical Sterile Ophthalmic Solution
| Study group | Role | What they receive |
|---|---|---|
| Nyxol Ophthalmic Solution 1% | Experimental | 1 drop in each eye daily (QD) at or before bedtime (8pm to 10pm) for 14 days Receives: Drug: Phentolamine Mesylate Ophthalmic Solution 1% |
| Nyxol Ophthalmic Solution Vehicle | Placebo comparator | 1 drop in each eye daily (QD) at or before bedtime (8pm to 10pm) for 14 days 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.
Intraocular Pressure
change from Baseline in mean diurnal IOP in the study eye
Measured: 15 days
Secondary outcomes (3)
Pupil Diameter
Change from Baseline Pupil Diameter (Photopic Conditions)
Measured: 15 days
Distance Visual Acuity
Percentage of Subjects Achieving ≥1 line improvement in Distance Visual Acuity from Baseline measured at 4 meters (photopic conditions)
Measured: 15 days
Conjunctival Hyperemia
Conjunctival Hyperemia Category
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 posted23 May 2019
- Study start28 May 2019
- Primary completion11 Sep 2019
- Study completion11 Sep 2019
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 Open Angle GlaucomaStudies 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
- 39 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
- NCT03960866
- Sponsor's protocol ID
- OPI-NYXG-201 (ORION-1)
- Status last verified
- Aug 2023
- First submitted
- 21 May 2019
- Last updated
- 30 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 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 Phentolamine Mesylate Ophthalmic Solution in Subjects With Open Angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT03960866
- Acronym / sponsor ID
- OPI-NYXG-201 (ORION-1)
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Keywords
- Open Angle Glaucoma, Ocular Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Opus Genetics, IncIndustry (pharma, biotech, devices)
- Study start
- 28 May 2019 (actual)
- Primary completion
- 11 Sep 2019 (actual)
- Study completion
- 11 Sep 2019 (actual)
- First posted
- 23 May 2019 (actual)
- Results
- Posted 12 Jul 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 Phentolamine Mesylate to lower intra-ocular pressure (IOP) in the treatment of Open-Angle Glaucoma (OAG) and Ocular Hypertension (OHT).
- To evaluate the ocular and systemic safety of Phentolamine Mesylate compared to its vehicle.
- To evaluate additional efficacy of Phentolamine Mesylate to improve visual performance.
Detailed description
Placebo-controlled double-masked, multiple dose Phase 2 study in 40 patients with IOP ≥ 22 and ≤30 mmHg, evaluating ocular and systemic safety and efficacy following administration of Phentolamine mesylate 1.0% QD at 8PM to 10PM in both eyes for 14 days.
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 |
|---|---|---|
| Nyxol Ophthalmic Solution 1% | Experimental | Drug: Phentolamine Mesylate Ophthalmic Solution 1%1 drop in each eye daily (QD) at or before bedtime (8pm to 10pm) for 14 days |
| Nyxol Ophthalmic Solution Vehicle | Placebo comparator | Other: Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)1 drop in each eye daily (QD) at or before bedtime (8pm to 10pm) for 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years of age or greater
- Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT). A reported history of untreated OHT with IOP ≥22mmHg and ≤ 30mmHg is preferred.
- Untreated or treated OAG/OHT with 2 or fewer ocular hypotensive medications.
- Untreated (post-washout) mean IOP ≥ 22mmHg and ≤30mmHg in the study eye at the Qualification Visit (8AM).
- Corrected visual acuity in each eye +1.0 logMAR or better by Early Treatment Diabetic Retinopathy Study (ETDRS) in each eye (equivalent to 20/200 or better) at the Screening Visit and Qualification Visit.
Key exclusion criteria (21 listed)
- Closed or very narrow angles (Grade 0-1, Shaffer)
- Glaucoma: pseudo-exfoliation or pigment dispersion component
- Known hypersensitivity to any α-adrenoceptor antagonists
- Previous laser and/or non-laser glaucoma surgery or procedure in either eye
- Refractive surgery in either eye
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%Also: Nyxol®Topical Sterile Ophthalmic Solution | Drug | Nyxol Ophthalmic Solution 1% |
| Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)Topical Sterile Ophthalmic Solution | Other | Nyxol Ophthalmic Solution Vehicle |
Primary outcome
Intraocular Pressure
Time frame: 15 days
change from Baseline in mean diurnal IOP in the study eye
3 secondary outcomes
Pupil Diameter
Time frame: 15 days
Distance Visual Acuity
Time frame: 15 days
Conjunctival Hyperemia
Time frame: 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
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites 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 Open Angle Glaucoma and Ocular Hypertension, run by Opus Genetics, Inc at 5 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 8 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 5 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 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 12 Jul 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?
Intraocular Pressure (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 30 Oct 2026.