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The 95% confidence interval for non-inferiority was met before planned enrollment was reached.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dorzolamide/timolol | Drug | Compare half-frequency dosing of latanoprost and dorzolamide/timolol to full dosing. Compare also to timolol/brimonidine/dorzolamide/bimatoprost |
|
| Measure | Description | Time Frame |
|---|---|---|
| intraocular pressure | measured by pneumatonometry and Goldmann tonometry | 3 weeks after each phase |
| Measure | Description | Time Frame |
|---|---|---|
| dry eye | assess punctate staining of cornea and subjective symptoms | 3 weeks after each phase |
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Inclusion Criteria:
Exclusion Criteria:
The final determination to be included in the study will be made by the Physician on the day of the appointment.
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| Name | Affiliation | Role |
|---|---|---|
| Peter E Libre, MD | CT Glaucoma Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CT Glaucoma Associates | Norwalk | Connecticut | 06851 | United States |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C479140 | dorzolamide-timolol combination |
| D000077338 | Latanoprost |
| D013999 | Timolol |
| ID | Term |
|---|---|
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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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.
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Technician measuring IOP and assessing dry eye is masked regarding phase 2 and phase 3 crossover assignment order.
|
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009025 | Morpholines |
| D010078 | Oxazines |