Use of Methazolamide to Lower Intraocular Pressure

Overview

The purpose of this study is to evaluate the effect of methazolamide, 25 mg or 50 mg tablets once a day for a week than twice a day for a week, on lowering intraocular pressure and the safety of methazolamide.

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Double (Participant, Outcomes Assessor)
• Study Primary Completion Date: July 31, 2023

Interventions

• Drug: Methazolamide 25 MG
  • 25 mg tablets
• Drug: Methazolamide 50 MG
  • 50 mg tablets

Arms, Groups and Cohorts

• Active Comparator: Methazolamide 25 mg
  • Once a day [q.d] in the morning for 1 week, Twice a day [b.i.d.] in the morning and evening for 1 week
• Active Comparator: Methazolamide 50 mg
  • Once a day [q.d] in the morning for 1 week, Twice a day [b.i.d.] in the morning and evening for 1 week

Clinical Trial Outcome Measures

Primary Measures

• Percent IOP change at each follow-up Visit
  • Time Frame: Day 1 (Pre-dosing, then 4- and 8- hours post dosing), Day 7 (Pre-dosing, then 4- and 8- hours post dosing), Day 14 (Pre-dosing, then 4- and 8- hours post dosing)
  • IOP measure is measured using Goldmann Tonometry. IOP is measured in mmHg with a normal range from 12 mmHg to 22 mmHg.

Participating in This Clinical Trial

Inclusion Criteria

• Males and females between 50 and 90 years old – Current diagnosis of open angle glaucoma (OAG) in both eyes – Ability to read and write in English Exclusion Criteria:

• Glaucoma other than OAG – Severe or end-stage glaucoma (cup to disc ratio >0.8 or Mean Deviation on Visual Field worse than -12) – Pregnant or breast-feeding women

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • University of Colorado, Denver
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Malik Y. Kahook, MD, Principal Investigator, University of Colorado, Denver
• Overall Contact(s)
  • Sarah M. Wilting, OD, 720-848-6989, sarah.wilting@cuanschutz.edu