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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-22

Study Completion Date

2024-07-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Glaucoma, Open-Angle Glaucoma; Drugs

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Technician measuring IOP and assessing dry eye is masked regarding phase 2 and phase 3 crossover assignment order.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

dorzolamide/timolol

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

dorzolamide/timolol

Intervention Type DRUG

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

Interventions

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dorzolamide/timolol

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

Intervention Type DRUG

Other Intervention Names

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latanoprost timolol/brimonidine/dorzolamide/bimatoprost

Eligibility Criteria

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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