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Safety and Efficacy of Ophthalmic Phentolamine Mesylate in Glaucoma

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ClinicalTrials.gov Identifier: NCT03960866
Recruitment Status : Completed
First Posted : May 23, 2019
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
Ocuphire Pharma, Inc.

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
Open Angle Glaucoma Ocular Hypertension 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.

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Study Type : Interventional  (Clinical Trial)
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 : September 11, 2019
Actual Study Completion Date : September 11, 2019


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 Name: 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




Primary Outcome Measures :
  1. Intraocular Pressure [ Time Frame: 14 days ]
    change from Baseline in mean diurnal IOP in the study eye


Secondary Outcome Measures :
  1. Distance Visual Acuity [ Time Frame: 14 days ]
    Change in Distance Visual Acuity from Baseline measured at 4 meters (photopic and mesopic)

  2. Near Visual Acuity [ Time Frame: 14 days ]
    Change in Near Visual Acuity from Baseline measured at 16 inches (photopic and mesopic)

  3. Pupil Diameter [ Time Frame: 14 days ]
    Change and percent change from Baseline in Pupil Diameter (mesopic and photopic)

  4. Conjunctival Hyperemia [ Time Frame: 14 days ]
    Change in Conjunctival Hyperemia score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03960866


Locations
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United States, California
North Valley Eye Medical Group
Mission Hills, California, United States, 91345
United States, Georgia
Clayton Eye Clinical Research
Morrow, Georgia, United States, 30260
United States, Michigan
University of Michigan Kellogg Eye Center
Ann Arbor, Michigan, United States, 48105
United States, New York
Rochester Ophthalmological Group
Rochester, New York, United States, 14618
United States, Ohio
Abrams Eye Center
Cleveland, Ohio, United States, 44115
Sponsors and Collaborators
Ocuphire Pharma, Inc.

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Responsible Party: Ocuphire Pharma, Inc.
ClinicalTrials.gov Identifier: NCT03960866     History of Changes
Other Study ID Numbers: OPI-NYXG-201 (ORION-1)
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Phentolamine
Ophthalmic Solutions
Pharmaceutical Solutions
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents