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Carbonic Anhydrase Inhibitor
Methazolamide for Glaucoma
Phase 4
Waitlist Available
Led By Malik Y. Kahook, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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)
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing whether methazolamide can safely and effectively lower intraocular pressure.
Who is the study for?
This trial is for English-reading men and women aged 50 to 90 with open-angle glaucoma in both eyes. It's not for those with other types of glaucoma, severe or end-stage glaucoma, or if they are pregnant or breastfeeding.
What is being tested?
The study tests methazolamide tablets at doses of 25 mg and 50 mg to lower eye pressure in glaucoma patients. Participants will take one dose daily for a week, then twice daily for another week to assess effectiveness and safety.
What are the potential side effects?
Methazolamide may cause side effects like fatigue, loss of appetite, taste alterations, tingling in hands or feet, diarrhea, kidney stones, and rarely blood cell disorders.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percent IOP change at each follow-up Visit
Secondary study objectives
Body Weight Changes
Body Weight Changes
Body Weight Changes
+2 moreAwards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Active Control
Group I: Methazolamide 25 mgActive Control1 Intervention
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
Group II: Methazolamide 50 mgActive Control1 Intervention
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
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Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,809 Previous Clinical Trials
2,822,228 Total Patients Enrolled
Malik Y. Kahook, MDPrincipal InvestigatorUniversity of Colorado, Denver
6 Previous Clinical Trials
175 Total Patients Enrolled