Safety and Efficacy of Ophthalmic Phentolamine Mesylate in Glaucoma
Condition: Open Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Phentolamine Mesylate Ophthalmic Solution 1%; Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)
Intervention description: Topical Sterile Ophthalmic Solution; Topical Sterile Ophthalmic Solution
Intervention MeSH terms: Phentolamine; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Open Angle Glaucoma; Ocular Hypertension

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.
    

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