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

Phase 4TerminatedNCT06369077

CT Glaucoma Associates36 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Glaucoma, Open-Angle Glaucoma; Drugs

Interventions

dorzolamide/timololDRUG

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

Eligibility

Sex: ALLMin age: 25 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

CT Glaucoma Associates

Norwalk, Connecticut, United States

Outcomes

Primary Outcomes

intraocular pressure

measured by pneumatonometry and Goldmann tonometry

Time frame: 3 weeks after each phase

Secondary Outcomes

dry eye

assess punctate staining of cornea and subjective symptoms

Time frame: 3 weeks after each phase

Data from ClinicalTrials.gov

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