Safety and Efficacy of Ophthalmic Phentolamine Mesylate in Glaucoma

Ocular Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03960866
• Other study ID #: OPI-NYXG-201 (ORION-1)
• Status: Completed
• Phase: Phase 2
• Start date: May 28, 2019
• Est. completion date: September 11, 2019

Study information

• Verified date: August 2023
• Source: Ocuphire Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. - To evaluate additional efficacy of Phentolamine Mesylate to improve visual performance.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: September 11, 2019
• Est. primary completion date: September 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 a-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 a- and/or ß-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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open Angle Glaucoma

Intervention

Drug:
• Phentolamine Mesylate Ophthalmic Solution 1%
Topical Sterile Ophthalmic Solution

Other:
• Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)
Topical Sterile Ophthalmic Solution

Locations

Country	Name	City	State
United States	University of Michigan Kellogg Eye Center	Ann Arbor	Michigan
United States	Abrams Eye Center	Cleveland	Ohio
United States	North Valley Eye Medical Group	Mission Hills	California
United States	Clayton Eye Clinical Research	Morrow	Georgia
United States	Rochester Ophthalmological Group	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Ocuphire Pharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular Pressure	change from Baseline in mean diurnal IOP in the study eye	15 days
Secondary	Pupil Diameter	Change from Baseline Pupil Diameter (Photopic Conditions)	15 days
Secondary	Distance Visual Acuity	Percentage of Subjects Achieving =1 line improvement in Distance Visual Acuity from Baseline measured at 4 meters (photopic conditions)	15 days
Secondary	Conjunctival Hyperemia	Conjunctival Hyperemia Category	15 days