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Prospective study to compare the efficacy of two fixed drug combinations in patients with high IOP.

A prospective randomised clinical trial to compare the ocular hypotensive effect and safety of brinzolamide1% and brimonidine0.2% combination vs bimatoprost 0.03% and timolol 0.5% in primary open angle glaucoma, ocular hypertension and normotensive glaucoma.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/04/024603
Enrollment
100
Registered
2020-04-13
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H401- Open-angle glaucoma

Interventions

Intervention1: brinzolamide1% and brimonidine0.2% combination: Eye drops brinzolamide1% and brimonidine0.2% combination twice daily for 12 weeks Control Intervention1: Bimatoprost 0.03% and Timolol 0.

Sponsors

Dr Arvind Kumar Morya
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with OAG or OH or NTG who have high IOP despite using single drug therapy for more than 1 month. 2. Patients requiring multiple drug therapy. 3. Aged 18 years or over. 4. Patients could be of either gender. 5. Could be inpatients or outpatients.

Exclusion criteria

Exclusion criteria: 1. Chronic or recurrent ocular inflammation. 2. History of ocular trauma within 6 months before baseline measurements. 3. Ocular infection. 4. Severe retinal disease. 5. Condition affecting applanation tonometry in either eye. 6. Laser surgery on either eye within 3 month before baseline measurements. 7. Known hypersensitivity to carbonic anhydrase inhibitors, b-blockers, ophthalmic prostaglandins, or benzalkonium chloride. 8. Initiation of systemic treatment with medications that may influence IOP within 1 month before study enrollment (sympathomimetics, b-blockers, a1-blockers, a/b-blockers, Ca antagonists, and ACE inhibitors). 9. Advanced neurologic disorder. 10. Patients with lid/ eyelashes abnormalities. 11. Patients with severe dry eye. 12. Contraindication to b-blockers.

Design outcomes

Primary

MeasureTime frame
To compare decrease in IOP in both the groups.Timepoint: 1 year—

Secondary

MeasureTime frame
To campare halt in progression of visual field defects and thickness of retinal nerve fibre layer.Timepoint: 1 year—

Countries

India

Contacts

Public ContactDr Arvind Kumar Morya

AIIMS Jodhpur

dr.prad99@gmail.com8003996952

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026