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

Phase 4

Terminated

• Conditions: Glaucoma, Open-Angle; Glaucoma; Drugs
• Interventions: Drug: dorzolamide/timolol

• Registration Number: NCT06369077
• Lead Sponsor: CT Glaucoma Associates

Brief 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.

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 Timeline

• Study First Submitted: 2024-04-12
• Study First Submitted QC: 2024-04-12
• Study First Posted: 2024-04-16
• Study Start: 2024-04-22
• Primary Completion: 2024-07-30
• Study Completion: 2024-07-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 36

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
full dose lat dor-tim; tim-brim-dor-bim	dorzolamide/timolol	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.
tim-brim-dor-bim; full dose lat dor-tim	dorzolamide/timolol	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.

Primary Outcome Measures

Name	Time	Method
intraocular pressure	3 weeks after each phase	measured by pneumatonometry and Goldmann tonometry

Secondary Outcome Measures

Name	Time	Method
dry eye	3 weeks after each phase	assess punctate staining of cornea and subjective symptoms

Trial Locations

Locations (1)

CT Glaucoma Associates; 🇺🇸 Norwalk, Connecticut, United States