Clinical trial NCT06369077: How Much Does Reduced Dosing of Latanoprost and Dorzolamide-timolol Affect Pressure?
Official title: Cross-over Comparison of Latanoprost QOD With Dor-tim QAM to Tim-brim-dor-bim(Atoprost) qd or Lat QD With Dor-tim BID
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Glaucoma, Open-Angle
Glaucoma; Drugs
Keywords: dosing
Lead sponsor: CT Glaucoma Associates
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 36
Sex: ALL
Minimum age (years): 25
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: intraocular pressure
timeFrame: 3 weeks after each phase
Secondary outcomes:
measure: dry eye
timeFrame: 3 weeks after each phase
Other outcomes:
Locations:
city: Norwalk
country: United States
facility: CT Glaucoma Associates
state: Connecticut
Study officials:
affiliation: CT Glaucoma Associates
name: Peter E Libre, MD
role: PRINCIPAL_INVESTIGATOR
References: