Health Condition 1: H408- Other glaucoma
Conditions
Interventions
Intervention1: Fixed dose combination (FDC) of Timolol 0.5%, Brimonidine 0.2% and Brinzolamide 1% eye drops (Trisopt): Dose: One drop of the FDC (Fixed Dose Combination) of Timolol 0.5%, Brimonidine 0
Sponsors
Dr Alokesh Ganguly
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female subjects aged 18 years with glaucoma or ocular hypertensives (one eye/both eyes) confirmed by Goldmann applanation tonometry. 2. Subject with known cases of glaucoma requires early intensification (Physician discretion for assessment) 3. Gonioscopy angle of 20 degree in the study eye 4. Subjects willing to comply with the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Subjects with known hypersensitivity to any of the components of the formulation. 2. Subjects who are completely blind 3. Subjects who are scheduled to undergo eye surgery during the study period. 4. Pregnancy and lactation: Pregnant or lactating or planning to become pregnant during the study period. Females who are not ready to use acceptable contraceptive methods during the course of study. 5. Trial related conditions: Suspected inability or unwillingness to comply with the study procedures. 6. Any other conditions which would make the patient, in the opinion of the Investigator, unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This outcome will establish the IOP-lowering potential of the fixed-dose combination (FDC).Timepoint: Week 2, Week 8,Week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcomes Safety & tolerability of the FDC eye drops will be evaluated based on: Incidence of treatment-emergent adverse events (TEAEs) Changes in ophthalmologic parameters, such as: Visual Acuity (VA) Slit-lamp biomicroscopy findingsTimepoint: Week 2, Week 8,Week 12. | — |
Countries
India
Contacts
Public ContactDr Alokesh Ganguly
Priyamvada Birla Aravind Eye Hospital
Outcome results
None listed