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Safety and Efficacy of Ophthalmic Phentolamine Mesylate in Glaucoma

Sponsor
Ocuphire Pharma, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03960866
Collaborator
(none)
39
Enrollment
5
Locations
2
Arms
3.5
Actual Duration (Months)
7.8
Patients Per Site
2.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Phentolamine Mesylate Ophthalmic Solution 1%
  • Other: Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)
 Phase 2

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

Study Type:
Interventional
Actual Enrollment :
39 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
May 28, 2019
Actual Primary Completion Date :
Sep 11, 2019
Actual Study Completion Date :
Sep 11, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Nyxol Ophthalmic Solution 1%

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

Drug: Phentolamine Mesylate Ophthalmic Solution 1%
Topical Sterile Ophthalmic Solution
Other Names:
  • Nyxol®

    		•
    Placebo Comparator: Nyxol Ophthalmic Solution Vehicle

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

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

    Outcome Measures

    Primary Outcome Measures

    1. Intraocular Pressure [14 days]

      change from Baseline in mean diurnal IOP in the study eye

    Secondary Outcome Measures

    1. Distance Visual Acuity [14 days]

      Change in Distance Visual Acuity from Baseline measured at 4 meters (photopic and mesopic)

    2. Near Visual Acuity [14 days]

      Change in Near Visual Acuity from Baseline measured at 16 inches (photopic and mesopic)

    3. Pupil Diameter [14 days]

      Change and percent change from Baseline in Pupil Diameter (mesopic and photopic)

    4. Conjunctival Hyperemia [14 days]

      Change in Conjunctival Hyperemia score

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 North Valley Eye Medical Group Mission Hills California United States 91345
    2 Clayton Eye Clinical Research Morrow Georgia United States 30260
    3 University of Michigan Kellogg Eye Center Ann Arbor Michigan United States 48105
    4 Rochester Ophthalmological Group Rochester New York United States 14618
    5 Abrams Eye Center Cleveland Ohio United States 44115

    Sponsors and Collaborators

    • Ocuphire Pharma, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ocuphire Pharma, Inc.
    ClinicalTrials.gov Identifier:
    NCT03960866
    Other Study ID Numbers:
    • OPI-NYXG-201 (ORION-1)
    First Posted:
    May 23, 2019
    Last Update Posted:
    Oct 14, 2019
    Last Verified:
    Oct 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Ocuphire Pharma, Inc.
    Open Angle Glaucoma
    Ocular Hypertension
    Additional relevant MeSH terms:
    Glaucoma
    Glaucoma, Open-Angle
    Ocular Hypertension
    Hypertension
    Phentolamine
    Pharmaceutical Solutions
    Ophthalmic Solutions

    Study Results

    No Results Posted as of Oct 14, 2019