Safety and Efficacy of Ophthalmic Phentolamine Mesylate in Glaucoma
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
1 other identifier
interventional
39
1 country
5
Brief 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.
- To evaluate additional efficacy of Phentolamine Mesylate to improve visual performance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2019
Shorter than P25 for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2019
CompletedFirst Posted
Study publicly available on registry
May 23, 2019
CompletedStudy Start
First participant enrolled
May 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 11, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 11, 2019
CompletedResults Posted
Study results publicly available
July 12, 2023
CompletedSeptember 13, 2023
August 1, 2023
4 months
May 21, 2019
December 23, 2021
August 18, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intraocular Pressure
change from Baseline in mean diurnal IOP in the study eye
15 days
Secondary Outcomes (3)
Pupil Diameter
15 days
Distance Visual Acuity
15 days
Conjunctival Hyperemia
15 days
Study Arms (2)
Nyxol Ophthalmic Solution 1%
EXPERIMENTAL1 drop in each eye daily (QD) at or before bedtime (8pm to 10pm) for 14 days
Nyxol Ophthalmic Solution Vehicle
PLACEBO COMPARATOR1 drop in each eye daily (QD) at or before bedtime (8pm to 10pm) for 14 days
Interventions
Topical Sterile Ophthalmic Solution
Topical Sterile Ophthalmic Solution
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
North Valley Eye Medical Group
Mission Hills, California, 91345, United States
Clayton Eye Clinical Research
Morrow, Georgia, 30260, United States
University of Michigan Kellogg Eye Center
Ann Arbor, Michigan, 48105, United States
Rochester Ophthalmological Group
Rochester, New York, 14618, United States
Abrams Eye Center
Cleveland, Ohio, 44115, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mina Sooch
- Organization
- Ocuphire Pharma, Inc.
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2019
First Posted
May 23, 2019
Study Start
May 28, 2019
Primary Completion
September 11, 2019
Study Completion
September 11, 2019
Last Updated
September 13, 2023
Results First Posted
July 12, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share