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NCT06369077 Clinical Trial

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

Glaucoma, Open-Angle Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06369077
Other study ID # CTGlaucoma1
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date April 2024
Est. completion date July 2024

Study information
Verified date April 2024
Source CT Glaucoma Associates
Contact Peter E Libre, MD
Phone 203 853 2020
Email pel3@cumc.columbia.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date July 2024
Est. primary completion date July 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 90 Years
Eligibility 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: - 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.

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States CT Glaucoma Associates Norwalk Connecticut

Sponsors (1)
Lead Sponsor Collaborator
CT Glaucoma Associates

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary intraocular pressure measured by pneumatonometry and Goldmann tonometry 3 weeks after each phase
Secondary dry eye assess punctate staining of cornea and subjective symptoms 3 weeks after each phase
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