Back to resultsUse of Methazolamide to Lower Intraocular Pressure
Primary Purpose
Glaucoma, Open-Angle
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Methazolamide 25 MG
Methazolamide 50 MG
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma, Open-Angle focused on measuring Glaucoma, Methazolamide, Primary Open Angle Glaucoma
Eligibility Criteria
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
Sites / Locations
- Sue Anschutz-Rodgers Eye CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Methazolamide 25 mg
Methazolamide 50 mg
Arm Description
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
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05498103
First Posted
August 9, 2022
Last Updated
December 19, 2022
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT05498103
Brief Title
Use of Methazolamide to Lower Intraocular Pressure
Official Title
Use of Methazolamide to Lower Intraocular Pressure
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Anticipated)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
August 7, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open-Angle
Keywords
Glaucoma, Methazolamide, Primary Open Angle Glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Double
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Methazolamide 25 mg
Arm Type
Active Comparator
Arm Description
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
Arm Title
Methazolamide 50 mg
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Methazolamide 25 MG
Intervention Description
25 mg tablets
Intervention Type
Drug
Intervention Name(s)
Methazolamide 50 MG
Intervention Description
50 mg tablets
Primary Outcome Measure Information:
Title
Percent IOP change at each follow-up Visit
Description
IOP measure is measured using Goldmann Tonometry. IOP is measured in mmHg with a normal range from 12 mmHg to 22 mmHg.
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah M. Wilting, OD
Phone
720-848-6989
Email
sarah.wilting@cuanschutz.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malik Y. Kahook, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sue Anschutz-Rodgers Eye Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Wilting, OD
Phone
720-848-6989
Email
sarah.wilting@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Malik Y. Kahook, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Use of Methazolamide to Lower Intraocular Pressure
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