Use of Methazolamide to Lower Intraocular Pressure

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 Overview

• Status: Active, not recruiting
• Conditions: Glaucoma, Open-Angle
• Intervention / Treatment: Drug: Methazolamide 25 MG; Drug: Methazolamide 50 MG

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Sue Anschutz-Rodgers Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: Methazolamide 25 MG; 25 mg tablets
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	Drug: Methazolamide 50 MG; 50 mg tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent IOP change at each follow-up Visit	IOP measure is measured using Goldmann Tonometry. IOP is measured in mmHg with a normal range from 12 mmHg to 22 mmHg.	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)

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Malik Y. Kahook, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2023
• Primary Completion (Actual): September 14, 2023
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: August 9, 2022
• First Submitted That Met QC Criteria: August 9, 2022
• First Posted (Actual): August 11, 2022

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Glaucoma; Primary Open Angle Glaucoma; Methazolamide
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Carbonic Anhydrase Inhibitors; Natriuretic Agents; Diuretics; Methazolamide
• Other Study ID Numbers: 22-0721

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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.: Yes