Safety and Efficacy of Ophthalmic Phentolamine Mesylate in Glaucoma

NCT ID: NCT03960866

Last Updated: 2023-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-28
• Study Completion Date: 2019-09-11

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.

Conditions

Open Angle Glaucoma; Ocular Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Nyxol Ophthalmic Solution 1%

1 drop in each eye daily (QD) at or before bedtime (8pm to 10pm) for 14 days

Group Type: EXPERIMENTAL

Phentolamine Mesylate Ophthalmic Solution 1%

Intervention Type: DRUG

Topical Sterile Ophthalmic Solution

Nyxol Ophthalmic Solution Vehicle

1 drop in each eye daily (QD) at or before bedtime (8pm to 10pm) for 14 days

Group Type: PLACEBO_COMPARATOR

Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)

Intervention Type: OTHER

Topical Sterile Ophthalmic Solution

Interventions

Phentolamine Mesylate Ophthalmic Solution 1%

Topical Sterile Ophthalmic Solution

Intervention Type: DRUG

Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)

Topical Sterile Ophthalmic Solution

Intervention Type: OTHER

Other Intervention Names

Nyxol®

Eligibility Criteria

Inclusion Criteria

1. 18 years of age or greater

2. Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT). A reported history of untreated OHT with IOP ≥22mmHg and ≤ 30mmHg is preferred.

3. Untreated or treated OAG/OHT with 2 or fewer ocular hypotensive medications.

4. Untreated (post-washout) mean IOP ≥ 22mmHg and ≤30mmHg in the study eye at the Qualification Visit (8AM).

5. 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.

6. Otherwise healthy and well-controlled subjects.

7. Able and willing to give signed informed consent and follow study instructions.

8. Able to self-administer study medication or to have study medication administered by a caregiver throughout the study period.

Exclusion Criteria

1. Closed or very narrow angles (Grade 0-1, Shaffer)

2. Glaucoma: pseudo-exfoliation or pigment dispersion component

3. Known hypersensitivity to any α-adrenoceptor antagonists

4. Previous laser and/or non-laser glaucoma surgery or procedure in either eye

5. Refractive surgery in either eye

6. 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

7. Recent or current evidence of ocular infection or inflammation in either eye

8. Ocular medication in either eye of any kind within 30 days of Screening

9. Clinically significant ocular disease in either eye

10. History of diabetic retinopathy

11. Contact lens wear within 3 days prior to and for the duration of the study

12. Central corneal thickness in either eye >600 μm at Screening

13. Any abnormality in either eye preventing reliable applanation tonometry

14. Known hypersensitivity or contraindication to α- and/or β-adrenoceptor antagonists

15. Clinically significant systemic disease that might interfere with the study

16. Participation in any investigational study within 30 days prior to Screening

17. Use of any topical or systemic adrenergic or cholinergic drugs up to 30 days prior to Screening, or during the study

18. Changes in systemic medication that could have an effect on IOP within 30 days prior to Screening

19. Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control

20. Resting heart rate outside the normal range (50-110 beats per minute) at Screening or Qualification Visit

21. Hypertension with resting diastolic blood pressure (BP) > 105 mmHg or systolic BP > 160 mmHg at the Screening or Qualification Visit

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ocuphire Pharma, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

North Valley Eye Medical Group

Mission Hills, California, United States

Clayton Eye Clinical Research

Morrow, Georgia, United States

University of Michigan Kellogg Eye Center

Ann Arbor, Michigan, United States

Rochester Ophthalmological Group

Rochester, New York, United States

Abrams Eye Center

Cleveland, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

OPI-NYXG-201 (ORION-1)

Identifier Type: -

Identifier Source: org_study_id