Health Condition 1: H402- Primary angle-closure glaucoma
Conditions
Interventions
Intervention1: Trisopt ophthalmic suspension in Fixed Dose Combination: Single Vial fixed dose combination of Brinzolamide 1%, Brimonidine 0.2 % &
Timolol 0.5%.
Treatment Duration: 3 Months
Control I
Sponsors
Investigator initiated study
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or non-pregnant female aged 18 years or older with chronic open angle glaucoma or ocular hypertension in both eyes. 2. Provide signed and dated informed consent in accordance with good clinical practice (GCP) and local legislation prior to any study procedure. 3. Be able and willing to follow study instructions and complete all required visits. 4. Subject requires treatment of both eyes and is able to discontinue use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo appropriate washout period. 5. Baseline (Day 0/hour 0) IOP = 22 mm Hg and = 34 mm Hg in each eye and any asymmetry of IOP between the eyes no greater than 5 mm Hg. 6. Have a best spectacle-corrected visual acuity (BSCVA) equivalent to 20/200 or better in each eye. 7. Adequate wash-out period prior to baseline of any ocular hypotensive medication.
Exclusion criteria
Exclusion criteria: 1. Subjects with angle closure glaucoma 2. Females who are pregnant, breast feeding, or planning a pregnancy. 3. Females of childbearing potential who do not agree to utilize an adequate form of contraception. 4. Current, or past history of, severe hepatic or renal impairment 5. Current, or history within 2 months prior to baseline of, significant ocular disease, e.g., corneal edema, uveitis, ocular infection, or ocular trauma in either eye. 6. Current corneal abnormalities that would prevent accurate IOP readings with the Goldmann applanation tonometer. 7. Functionally significant visual field loss
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in IOP from baseline (Day 1) to Week 12.Timepoint: Change in IOP from baseline (Day 1) to Week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Drug Compliance by MARS-5Timepoint: Week 6 and Week 12 | — |
Countries
India
Contacts
Public ContactProf Dr Lional Raj D
Dr. Agarwals Eye Hospital
Outcome results
None listed