Glaucoma, Open-AnglePhase 4NCT06369077
How Much Does Reduced Dosing of Latanoprost and Dorzolamide-timolol Affect Pressure?
A Phase 4 study testing dorzolamide/timolol in people with Glaucoma, Open-Angle and Glaucoma; Drugs, run by CT Glaucoma Associates at 1 site in United States.
Trial summary
IOP effect of half-dose latanoprost dorzolamide-timolol will be compared to full dose. Further comparison will be made timolol-brimonidine-dorzolamide-bimatoprost. Dry eye effects of the different treatments will be assessed. Read more about this study
- Who is it for?
- Ages 25 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Open-Angle, Glaucoma; Drugs
- What is being tested?
- dorzolamide/timolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2024to 30 Jul 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 25 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult glaucoma patients who are taking drops: dor-tim and Latanoprost Ophthalmic Solution 0.005% (Lat) and come in for an appointment during the trial period
Who cannot join
- Patients who had an SLT or glaucoma procedure or surgery within 3 months of enrollment will be excluded. Other exclusion criteria include the logistical inability to follow up with the trial, the inability to relax eye muscles for an accurate tonometry measurement, and the inability to instill medications.
- The final determination to be included in the study will be made by the Physician on the day of the appointment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cross-over Comparison of Latanoprost QOD With Dor-tim QAM to Tim-brim-dor-bim(Atoprost) qd or Lat QD With Dor-tim BID
IOP effect of half-dose latanoprost dorzolamide-timolol will be compared to full dose. Further comparison will be made timolol-brimonidine-dorzolamide-bimatoprost. Dry eye effects of the different treatments will be assessed.
Read the detailed description
Subjects will have baseline IOP measurements (7-9 am and 3-5 pm) after using using latanoprost every other day and dorzolamide-timolol every morning. They will then randomly be assigned in phase 2 to either: double the frequency to latanoprost daily and dorzolamide-timolol twice daily; or use every morning compounded timolol-brimonidine-dorzolamide-bimatoprost. IOP measurements will be repeated 3 weeks after using the phase 2 medications. For phase 3, subjects will use the treatment to which they were not assigned in phase 2, and IOP measurements will again be repeated 3 weeks later.
At each study visit, dry eye signs will be assessed and brief dry eye survey will be administered.
- Conditions
- Glaucoma, Open-Angle, Glaucoma; Drugs
- Being tested
- dorzolamide/timolol
- Keywords
- dosing
- 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.
dorzolamide/timololDrug
Also called latanoprost, timolol/brimonidine/dorzolamide/bimatoprost
Compare half-frequency dosing of latanoprost and dorzolamide/timolol to full dosing. Compare also to timolol/brimonidine/dorzolamide/bimatoprost
| Study group | Role | What they receive |
|---|---|---|
| full dose lat dor-tim; tim-brim-dor-bim | Active comparator | After baseline IOP measurements, subjects in this arm will use the full dose full dose latanoprost and dorzolamide-timolol in phase 2, and then timolol-brimonidine-dorzolamide-bimatoprost in phase 3. Receives: Drug: dorzolamide/timolol |
| tim-brim-dor-bim; full dose lat dor-tim | Active comparator | After baseline IOP measurements, subjects in this arm will use timolol-brimonidine-dorzolamide-bimatoprost in phase 2, and then full dose latanoprost and dorzolamide-timolol in phase 3. Receives: Drug: dorzolamide/timolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraocular pressure
measured by pneumatonometry and Goldmann tonometry
Measured: 3 weeks after each phase
Secondary outcomes (1)
dry eye
assess punctate staining of cornea and subjective symptoms
Measured: 3 weeks after each phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start22 Apr 2024
- Primary completion30 Jul 2024
- Study completion30 Jul 2024
Why it stopped: The 95% confidence interval for non-inferiority was met before planned enrollment was reached.
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.
- 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
- Crossover
- Model description
- Subjects will have baseline IOP measurements (7-9 am and 3-5 pm) after using using latanoprost every other day and dorzolamide-timolol every morning. They will then randomly be assigned in phase 2 to either: double the frequency to latanoprost daily and dorzolamide-timolol twice daily; or use every morning compounded timolol-brimonidine-dorzolamide-bimatoprost. IOP measurements will be repeated 3 weeks after using the phase 2 medications. For phase 3, subjects will use the treatment to which they were not assigned in phase 2, and IOP measurements will again be repeated 3 weeks later. At each study visit, dry eye signs will be assessed and brief dry eye survey will be administered.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- CT Glaucoma Associates
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter E. Libre, CT Glaucoma Associates
- Investigators
- Peter E Libre, MD, Principal investigator, CT Glaucoma Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369077
- Sponsor's protocol ID
- CTGlaucoma1
- Status last verified
- Aug 2024
- First submitted
- 12 Apr 2024
- Last updated
- 23 Aug 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 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-over Comparison of Latanoprost QOD With Dor-tim QAM to Tim-brim-dor-bim(Atoprost) qd or Lat QD With Dor-tim BID
- ClinicalTrials.gov ID
- NCT06369077
- Acronym / sponsor ID
- CTGlaucoma1
- Conditions
- Glaucoma, Open-Angle, Glaucoma; Drugs
- Keywords
- dosing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The 95% confidence interval for non-inferiority was met before planned enrollment was reached.
- Enrolment
- 36 participants (actual)
- Lead sponsor
- CT Glaucoma AssociatesUniversity, hospital or other
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 16 Apr 2024 (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.
IOP effect of half-dose latanoprost dorzolamide-timolol will be compared to full dose. Further comparison will be made timolol-brimonidine-dorzolamide-bimatoprost. Dry eye effects of the different treatments will be assessed.
Detailed description
Subjects will have baseline IOP measurements (7-9 am and 3-5 pm) after using using latanoprost every other day and dorzolamide-timolol every morning. They will then randomly be assigned in phase 2 to either: double the frequency to latanoprost daily and dorzolamide-timolol twice daily; or use every morning compounded timolol-brimonidine-dorzolamide-bimatoprost. IOP measurements will be repeated 3 weeks after using the phase 2 medications. For phase 3, subjects will use the treatment to which they were not assigned in phase 2, and IOP measurements will again be repeated 3 weeks later.
At each study visit, dry eye signs will be assessed and brief dry eye survey will be administered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will have baseline IOP measurements (7-9 am and 3-5 pm) after using using latanoprost every other day and dorzolamide-timolol every morning. They will then randomly be assigned in phase 2 to either: double the frequency to latanoprost daily and dorzolamide-timolol twice daily; or use every morning compounded timolol-brimonidine-dorzolamide-bimatoprost. IOP measurements will be repeated 3 weeks after using the phase 2 medications. For phase 3, subjects will use the treatment to which they were not assigned in phase 2, and IOP measurements will again be repeated 3 weeks later. At each study visit, dry eye signs will be assessed and brief dry eye survey will be administered.
| Arm | Type | Receives |
|---|---|---|
| full dose lat dor-tim; tim-brim-dor-bim | Active comparator | Drug: dorzolamide/timololAfter baseline IOP measurements, subjects in this arm will use the full dose full dose latanoprost and dorzolamide-timolol in phase 2, and then timolol-brimonidine-dorzolamide-bimatoprost in phase 3. |
| tim-brim-dor-bim; full dose lat dor-tim | Active comparator | Drug: dorzolamide/timololAfter baseline IOP measurements, subjects in this arm will use timolol-brimonidine-dorzolamide-bimatoprost in phase 2, and then full dose latanoprost and dorzolamide-timolol in phase 3. |
Who may qualify
- Ages
- 25 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult glaucoma patients who are taking drops: dor-tim and Latanoprost Ophthalmic Solution 0.005% (Lat) and come in for an appointment during the trial period
Key exclusion criteria (2 listed)
- Patients who had an SLT or glaucoma procedure or surgery within 3 months of enrollment will be excluded. Other exclusion criteria include the logistical inability to follow up with the trial, the inability to relax eye muscles for an accurate tonometry measurement, and the inability to instill medications.
- The final determination to be included in the study will be made by the Physician on the day of the appointment.
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 |
|---|---|---|
| dorzolamide/timololAlso: latanoprost, timolol/brimonidine/dorzolamide/bimatoprostCompare half-frequency dosing of latanoprost and dorzolamide/timolol to full dosing. Compare also to timolol/brimonidine/dorzolamide/bimatoprost | Drug | full dose lat dor-tim; tim-brim-dor-bim, tim-brim-dor-bim; full dose lat dor-tim |
Primary outcome
intraocular pressure
Time frame: 3 weeks after each phase
measured by pneumatonometry and Goldmann tonometry
1 secondary outcome
dry eye
Time frame: 3 weeks after each phase
Results and safety
The study was stopped early (reason given: The 95% confidence interval for non-inferiority was met before planned enrollment was reached.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 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.
Peter E Libre, MD principal investigator
CT Glaucoma Associates
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 dorzolamide/timolol in people with Glaucoma, Open-Angle and Glaucoma; Drugs, run by CT Glaucoma Associates 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 1 inclusion and 2 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: stopped early, as of the sponsor's last update on 23 Aug 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?
The study was stopped early (reason given: The 95% confidence interval for non-inferiority was met before planned enrollment was reached.). Results are not available in the source record.
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?
intraocular pressure (time frame: 3 weeks after each phase). 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 23 Aug 2024.