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

CT Glaucoma Associates

Status and phase: Terminated; Phase 4

Conditions: Glaucoma, Open-Angle; Glaucoma; Drugs

Treatments: Drug: dorzolamide/timolol

Study type: Interventional

Funder types: Other

Identifiers

NCT06369077

CTGlaucoma1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 25 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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36 participants in 2 patient groups

full dose lat dor-tim; tim-brim-dor-bim

Active Comparator group

Description:

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.

Treatment:

Drug: dorzolamide/timolol

tim-brim-dor-bim; full dose lat dor-tim

Active Comparator group

Description:

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.

Treatment:

Drug: dorzolamide/timolol