Glaucoma; Drugs, Glaucoma, Open-Angle
Conditions
Keywords
dosing
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.
Interventions
Compare half-frequency dosing of latanoprost and dorzolamide/timolol to full dosing. Compare also to timolol/brimonidine/dorzolamide/bimatoprost
Sponsors
CT Glaucoma Associates
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Technician measuring IOP and assessing dry eye is masked regarding phase 2 and phase 3 crossover assignment order.
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.
Eligibility
Sex/Gender
ALL
Age
25 Years to 90 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| intraocular pressure | 3 weeks after each phase | measured by pneumatonometry and Goldmann tonometry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| dry eye | 3 weeks after each phase | assess punctate staining of cornea and subjective symptoms |
Countries
United States
Outcome results
None listed