Use of Methazolamide to Lower Intraocular Pressure
1 other identifier
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Feb 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2022
CompletedFirst Posted
Study publicly available on registry
August 11, 2022
CompletedStudy Start
First participant enrolled
February 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 14, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedFebruary 6, 2024
February 1, 2024
7 months
August 9, 2022
February 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Study Arms (2)
Methazolamide 25 mg
ACTIVE COMPARATOROnce a day \[q.d\] in the morning for 1 week, Twice a day \[b.i.d.\] in the morning and evening for 1 week
Methazolamide 50 mg
ACTIVE COMPARATOROnce a day \[q.d\] in the morning for 1 week, Twice a day \[b.i.d.\] in the morning and evening for 1 week
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sue Anschutz-Rodgers Eye Center
Aurora, Colorado, 80045, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Malik Y. Kahook, MD
University of Colorado, Denver
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Double
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2022
First Posted
August 11, 2022
Study Start
February 17, 2023
Primary Completion
September 14, 2023
Study Completion
December 1, 2024
Last Updated
February 6, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share