ClinicalTrials.gg
TerminatedNCT06369077Updated Aug 23, 2024

How Much Does Reduced Dosing of Latanoprost and Dorzolamide-timolol Affect Pressure?

A Phase 4 interventional study of dorzolamide/timolol in Glaucoma, Open-Angle and Glaucoma; Drugs, sponsored by CT Glaucoma Associates. Terminated at 1 site in United States. Open to participants aged 25 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-23.

Sponsored by CT Glaucoma Associates · Phase 4, Interventional, and Treatment

Why this study was terminated
The 95% confidence interval for non-inferiority was met before planned enrollment was reached.

From the registry’s dates

  • Primary completion was Jul 2024, 2 years 2 months ago, and no results have been posted to the registry.
Phase
Phase 4
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
25 Years to 90 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Glaucoma, Open-Angle
  • Glaucoma; Drugs

Keywords

  • dosing
03

In context

Glaucoma, Open-Angle

943 studies on the registry are indexed under Glaucoma, Open-Angle; 118 are open to participants now.

This study's enrollment of 36 is below the median of 80 across 710 interventional studies indexed under Glaucoma, Open-Angle.

Browse Glaucoma, Open-Angle studies →

Lead sponsor

This is the only study on the registry with CT Glaucoma Associates as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
36 participants (actual)

Study arms

  • Active comparator
    full dose lat dor-tim; tim-brim-dor-bim

    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.

    Drug: dorzolamide/timolol

  • Active comparator
    tim-brim-dor-bim; full dose lat dor-tim

    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.

    Drug: dorzolamide/timolol

Interventions

  • Drugdorzolamide/timolol

    Drug pages: Dorzolamide · Timolol

    Compare half-frequency dosing of latanoprost and dorzolamide/timolol to full dosing. Compare also to timolol/brimonidine/dorzolamide/bimatoprost

    Also known as: latanoprost, timolol/brimonidine/dorzolamide/bimatoprost

06

What researchers measure

Primary outcomes

  1. intraocular pressure

    measured by pneumatonometry and Goldmann tonometry

    Time frame: 3 weeks after each phase

Secondary outcomes

  1. dry eye

    assess punctate staining of cornea and subjective symptoms

    Time frame: 3 weeks after each phase

07

Study locations

1 site
  • CT Glaucoma Associates
    Norwalk, Connecticut 06851, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2024 to primary completion in Jul 2024, 3 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 12, 2024
First posted
Apr 16, 2024
StartActual
Apr 22, 2024
Primary completionActual
Jul 30, 2024
CompletionActual
Jul 30, 2024
Last update
Aug 23, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06369077
Lead sponsor
CT Glaucoma Associates
Responsible party
Peter E. Libre (Medical Director, CT Glaucoma Associates) — Principal investigator
First posted
Apr 16, 2024
Start date
Apr 22, 2024
Primary completion
Jul 30, 2024
Completion
Jul 30, 2024
Last update
Aug 23, 2024

Study contacts

Peter E Libre, MD
principal investigator · CT Glaucoma Associates

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drugs tested here: Dorzolamide · Timolol

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