A clinical Trial in patients suffering from open angle glaucoma or ocular hypertension. This clinical trial is to study effect, safety and tolerability of Brinzolamide + Timolol Ophthalmic Suspension (test product) in comparison to Dorzolamide plus Timolol Maleate (reference product)eye drops.

"A Clinical trial to study the efficacy, safety and tolerability of Brinzolamide 10 mg in combination with Timolol 5 mg Ophthalmic suspension vs Dorzolamide 20mg + Timolol Maleate 5mg Eye Drops for the Treatment of Patients With Open Angle Glaucoma or Ocular Hypertensionâ??

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/04/002609

Enrollment

200

Registered

2012-04-27

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: null- Open angle glaucoma or ocular hypertension Health Condition 2: H401- Open-angle glaucoma

Interventions

Intervention1: Brinzolamide 10mg in combination with Timolol Maleate 5mg Ophthalmic Suspension: One drop in the conjunctival sac of the affected eye(s) twice daily for 6 weeks Control Intervention1:

Eligibility

Inclusion criteria

Inclusion criteria: 1.Male and Female patients of age 18 years and older. 2.Patient having clinical diagnosis of ocular hypertension. 3.Availability of subjects for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.

Exclusion criteria

Exclusion criteria: 1.Male and Female patients of age less than 18 years. 2.A history of hypersensitivity to brinzolamide and other sulphonamides, timolol, or any other component of the medication. 3.Patients suffering from bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease. 4.Patients suffering from sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, or cardiogenic shock. 5.Patients suffering from severe allergic rhinitis and bronchial hyperreactivity. 6.Patients suffering from severe renal impairment (see Hepatic / Renal Impairment). 7.Patients who have participated in other clinical studies within 3 months. 8.Any condition which are likely to hinder the compliance with the protocol. 9.Patients should not take other topical or oral beta-blockers during the study period. 10.Patients with broken rear lens capsule or anterior eye lenses or in patients with known risk factors for cystoid macular edema or iritis / uveitis. 11.Eye surgery or laser treatment within 12 weeks prior to study enrollment. 12.Patients who are scheduled to undergo surgery of the opposite eye during the study period. 13.Patients who are required to wear contact lens during the study period. 14.Significant visual field loss or evidence of progressive visual field loss within the last year.

Design outcomes

Primary

Measure	Time frame
IOP (Intraocular pressure) MeasurementTimepoint: Day 0, first week, third week, sixth week	—

Secondary

Measure	Time frame
Eye pain, Eye redness, multicolored halos and headacheTimepoint: Day 0, first week, third week, sixth week	—

Countries

India

Contacts

Public ContactDr Shailesh Singh

Ajanta Pharma Ltd, Advent

shailesh.singh@ajantapharma.com022-66062111

Outcome results

None listed

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