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

Cross-over Comparison of Latanoprost QOD With Dor-tim QAM to Tim-brim-dor-bim(Atoprost) qd or Lat QD With Dor-tim BID

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.

Study Overview

• Status: Recruiting
• Conditions: Glaucoma, Open-Angle; Glaucoma; Drugs
• Intervention / Treatment: Drug: dorzolamide/timolol

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Peter E Libre, MD; Phone Number: 203 853 2020; Email: pel3@cumc.columbia.edu
• Study Contact Backup: Name: Faria Mahjabin, BA; Email: faria.mahjabin@quinnipiac.edu

Study Locations

• United States
  • Connecticut
    • Norwalk, Connecticut, United States, 06851
      • Recruiting
      • CT Glaucoma Associates
      • Contact: Faria Mahjabin, BA; Email: faria.mahjabin@quinnipiac.edu
      • Contact: Peter E Libre, MD; Phone Number: 203-853-2020; Email: pel3@cumc.columbia.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: dorzolamide/timolol; Compare half-frequency dosing of latanoprost and dorzolamide/timolol to full dosing. Compare also to timolol/brimonidine/dorzolamide/bimatoprost; Other Names: latanoprost; timolol/brimonidine/dorzolamide/bimatoprost
Active Comparator: 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.	Drug: dorzolamide/timolol; Compare half-frequency dosing of latanoprost and dorzolamide/timolol to full dosing. Compare also to timolol/brimonidine/dorzolamide/bimatoprost; Other Names: latanoprost; timolol/brimonidine/dorzolamide/bimatoprost

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraocular pressure	measured by pneumatonometry and Goldmann tonometry	3 weeks after each phase

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
dry eye	assess punctate staining of cornea and subjective symptoms	3 weeks after each phase

Collaborators and Investigators

• Sponsor: CT Glaucoma Associates
• Investigators: Principal Investigator: Peter E Libre, MD, CT Glaucoma Associates

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: April 12, 2024
• First Submitted That Met QC Criteria: April 12, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: dosing
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Enzyme Inhibitors; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Carbonic Anhydrase Inhibitors; Pharmaceutical Solutions; Ophthalmic Solutions; Timolol; Brimonidine Tartrate; Dorzolamide; Bimatoprost; Latanoprost
• Other Study ID Numbers: CTGlaucoma1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes