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

NCT06369077 | Terminated Phase 4 FDA Drug

• 1 other identifier: CTGlaucoma1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma, Open-Angle; Glaucoma; Drugs

Keywords

dosing

Outcome Measures

Primary Outcomes (1)

• intraocular pressure

  measured by pneumatonometry and Goldmann tonometry

  3 weeks after each phase

Secondary Outcomes (1)

• dry eye

  3 weeks after each phase

Study Arms (2)

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

ACTIVE COMPARATOR

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.

Drug: dorzolamide/timolol

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

ACTIVE COMPARATOR

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.

Drug: dorzolamide/timolol

Interventions

dorzolamide/timolol DRUG

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

Also known as: latanoprost, timolol/brimonidine/dorzolamide/bimatoprost

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

Eligibility Criteria

• Age: 25 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• The final determination to be included in the study will be made by the Physician on the day of the appointment.

Sponsors & Collaborators

• CT Glaucoma Associates: lead

Study Sites (1)

CT Glaucoma Associates

Norwalk, Connecticut, 06851, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Glaucoma

Interventions

dorzolamide-timolol combination; Latanoprost; Timolol

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines

Study Officials

• Peter E Libre, MD

  CT Glaucoma Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Technician measuring IOP and assessing dry eye is masked regarding phase 2 and phase 3 crossover assignment order.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Model Details: 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 Record Dates

• First Submitted: April 12, 2024
• First Posted: April 16, 2024
• Study Start: April 22, 2024
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)