Glaucoma, Open-AnglePhase 4NCT05498103
Use of Methazolamide to Lower Intraocular Pressure
A Phase 4 study testing Methazolamide 25 MG and Methazolamide 50 MG in people with Glaucoma, Open-Angle, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Glaucoma, Open-Angle
- What is being tested?
- Methazolamide 25 MG and Methazolamide 50 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2023to Dec 2024
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Sue Anschutz-Rodgers Eye Center
Aurora, Colorado, 80045
About this study
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.
- Conditions
- Glaucoma, Open-Angle
- Being tested
- Methazolamide 25 MG, Methazolamide 50 MG
- Keywords
- Glaucoma, Methazolamide, Primary Open Angle Glaucoma
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methazolamide 25 MGDrug
25 mg tablets
Methazolamide 50 MGDrug
50 mg tablets
| Study group | Role | What they receive |
|---|---|---|
| Methazolamide 25 mg | Active comparator | 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 Receives: Drug: Methazolamide 25 MG |
| Methazolamide 50 mg | Active comparator | 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 Receives: Drug: Methazolamide 50 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start17 Feb 2023
- Primary completion14 Sep 2023
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-AngleStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malik Y. Kahook, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05498103
- Sponsor's protocol ID
- 22-0721
- Status last verified
- Feb 2024
- First submitted
- 9 Aug 2022
- Last updated
- 6 Feb 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Methazolamide to Lower Intraocular Pressure
- ClinicalTrials.gov ID
- NCT05498103
- Acronym / sponsor ID
- 22-0721
- Conditions
- Glaucoma, Open-Angle
- Keywords
- Glaucoma, Methazolamide, Primary Open Angle Glaucoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 17 Feb 2023 (actual)
- Primary completion
- 14 Sep 2023 (actual)
- Study completion
- Dec 2024 (estimated)
- First posted
- 11 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methazolamide 25 mg | Active comparator | Drug: Methazolamide 25 MGOnce 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 comparator | Drug: Methazolamide 50 MGOnce a day [q.d] in the morning for 1 week, Twice a day [b.i.d.] in the morning and evening for 1 week |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methazolamide 25 MG25 mg tablets | Drug | Methazolamide 25 mg |
| Methazolamide 50 MG50 mg tablets | Drug | Methazolamide 50 mg |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malik Y. Kahook, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methazolamide 25 MG and Methazolamide 50 MG in people with Glaucoma, Open-Angle, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.