Safety and Efficacy of Ophthalmic Phentolamine Mesylate in Glaucoma
Primary Purpose
Open Angle Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Phentolamine Mesylate Ophthalmic Solution 1%
Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)
Sponsored by
About this trial
This is an interventional treatment trial for Open Angle Glaucoma focused on measuring Open Angle Glaucoma, Ocular Hypertension
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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
Sites / Locations
- North Valley Eye Medical Group
- Clayton Eye Clinical Research
- University of Michigan Kellogg Eye Center
- Rochester Ophthalmological Group
- Abrams Eye Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Nyxol Ophthalmic Solution 1%
Nyxol Ophthalmic Solution Vehicle
Arm Description
1 drop in each eye daily (QD) at or before bedtime (8pm to 10pm) for 14 days
1 drop in each eye daily (QD) at or before bedtime (8pm to 10pm) for 14 days
Outcomes
Primary Outcome Measures
Intraocular Pressure
change from Baseline in mean diurnal IOP in the study eye
Secondary Outcome Measures
Pupil Diameter
Change from Baseline Pupil Diameter (Photopic Conditions)
Distance Visual Acuity
Percentage of Subjects Achieving ≥1 line improvement in Distance Visual Acuity from Baseline measured at 4 meters (photopic conditions)
Conjunctival Hyperemia
Conjunctival Hyperemia Category
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03960866
Brief Title
Safety and Efficacy of Ophthalmic Phentolamine Mesylate in Glaucoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 28, 2019 (Actual)
Primary Completion Date
September 11, 2019 (Actual)
Study Completion Date
September 11, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ocuphire Pharma, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Angle Glaucoma, Ocular Hypertension
Keywords
Open Angle Glaucoma, Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nyxol Ophthalmic Solution 1%
Arm Type
Experimental
Arm Description
1 drop in each eye daily (QD) at or before bedtime (8pm to 10pm) for 14 days
Arm Title
Nyxol Ophthalmic Solution Vehicle
Arm Type
Placebo Comparator
Arm Description
1 drop in each eye daily (QD) at or before bedtime (8pm to 10pm) for 14 days
Intervention Type
Drug
Intervention Name(s)
Phentolamine Mesylate Ophthalmic Solution 1%
Other Intervention Name(s)
Nyxol®
Intervention Description
Topical Sterile Ophthalmic Solution
Intervention Type
Other
Intervention Name(s)
Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)
Intervention Description
Topical Sterile Ophthalmic Solution
Primary Outcome Measure Information:
Title
Intraocular Pressure
Description
change from Baseline in mean diurnal IOP in the study eye
Time Frame
15 days
Secondary Outcome Measure Information:
Title
Pupil Diameter
Description
Change from Baseline Pupil Diameter (Photopic Conditions)
Time Frame
15 days
Title
Distance Visual Acuity
Description
Percentage of Subjects Achieving ≥1 line improvement in Distance Visual Acuity from Baseline measured at 4 meters (photopic conditions)
Time Frame
15 days
Title
Conjunctival Hyperemia
Description
Conjunctival Hyperemia Category
Time Frame
15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
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
Facility Information:
Facility Name
North Valley Eye Medical Group
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Clayton Eye Clinical Research
City
Morrow
State/Province
Georgia
ZIP/Postal Code
30260
Country
United States
Facility Name
University of Michigan Kellogg Eye Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
Rochester Ophthalmological Group
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Abrams Eye Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Safety and Efficacy of Ophthalmic Phentolamine Mesylate in Glaucoma
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