A Clinical Study to evaluate the efficacy, safety and tolerability of triple fixed dose combination of Timolol 0.5% Brimonidine 0.2% Brinzolamide 1% eye drops in patients with Open angle glaucoma or ocular hypertension not responding to dual drug therapy

Phase 3

Completed

• Conditions: Open-angle glaucoma,

• Registration Number: CTRI/2021/03/031676
• Lead Sponsor: Micro Labs Limited

Brief Summary

Glaucoma is associated with significant disability and global burden. The study is conducted to assess efficacy, safety and tolerability of triple combination of Timolol 0.5% + Brimonidine 0.2% + Brinzolamide 1% eye drops in patients with open angle glaucoma/ocular hypertension not responding to dual drug therapy. 

The mean ± SD change in IOP from baselineto end of study (week 12) was statistically significant (p<0.001). Gonioscopy, biomicroscopy,perimetry, C:D ratio, and Snellen’s BCVA results were comparable betweenbaseline and study end. There was statistically significantimprovement in ocular signs and symptoms, as reported by subjects, frombaseline to study end. There were no serious adverse events ordeath during the study. Safetyparameters viz,  Adverse events, ECG,Echo, biochemical parameters did not achieve statistical difference betweenbaseline and Week-12.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-04
• Last Update Posted: 2022-08-12
• Study Completion: 2022-09-19

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

1.Subjects ≥18 years of age of both gender 2.Diagnosed with unilateral or bilateral open angle glaucoma (including pseudo exfoliation or pigment dispersion) or ocular hypertension 3.Subjects who are already on dual drug therapy on any two of the following anti-glaucoma drugs, Timolol (0.5%), Brimonidine (0.1% or 0.2%), Brinzolamide (1%) /Dorzolamide (2%) eye drops with IOP of 22-32 mmHg in at least one eye 4.Best Corrected Visual Acuity (BCVA) of 6/24 or better in study eye(s) 5.Gonioscopy angle of ≥2 in the study eye (s) 6.In case of women, postmenopausal (>12 months without menstrual bleeding), surgically sterilized, or on use of effective birth control measures 7.Willing to complete all study-related procedures 8.Ability to understand and the willingness to sign and date a written informed consent document at the screening visit before any protocol specific procedures are performed.

Exclusion Criteria

• 1.Women of childbearing potential if pregnant (test positive for pregnancy) at screening visit, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
• 2.Clinically significant or progressive retinal disease (i.e. retinal degeneration, diabetic retinopathy, retinal detachment or retinal tears) or optic nerve disease.
• 3.Ocular laser surgery within the 3 months prior to entry.
• 4.Any abnormality preventing reliable applanation tonometry.
• 5.Any other conditions which would make the patient, in the opinion of the Investigator, unsuitable for the study.
• 6.Recent use of high-dose (>1 gram daily) salicylate therapy.
• 7.Subject with known allergy or hypersensitivity to the components of the formulation 8.Participation in another clinical trial within past 30 days 9.Other protocol-specified exclusion criteria may apply.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Intraocular Pressure (IOP)	Baseline to Week 12

Secondary Outcome Measures

Name	Time	Method
Change from baseline in the mean IOP at week 2 and week 6	Baseline to week 2, week 6

Trial Locations

Locations (15)

Aravind Eye Hospital Post Graduate Institute of Ophthalmology, Madurai; 🇮🇳 Madurai, TAMIL NADU, India

Aravind Eye Hospital, Post Graduate Institute of Ophthalmology Coimbatore; 🇮🇳 Coimbatore, TAMIL NADU, India

BJ Medical College and Sassoon General Hospitals; 🇮🇳 Pune, MAHARASHTRA, India

Dr. Shroff’s Charity Eye Hospital; 🇮🇳 North, DELHI, India

GCS Medical College, Hospital and Research Centre; 🇮🇳 Ahmadabad, GUJARAT, India

Government Medical College and Hospital RIMS Srikakulam; 🇮🇳 Srikakulam, ANDHRA PRADESH, India

King Georges Medical University; 🇮🇳 Lucknow, UTTAR PRADESH, India

LV Prasad Eye Institute, Bhubaneshwar; 🇮🇳 Cuttack, ORISSA, India

LV Prasad Eye Institute, Hyderabad; 🇮🇳 Hyderabad, TELANGANA, India

Narayana Nethralaya; 🇮🇳 Bangalore, KARNATAKA, India

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Aravind Eye Hospital Post Graduate Institute of Ophthalmology, Madurai

🇮🇳Madurai, TAMIL NADU, India

Dr R Krishna Das

Principal investigator

04524356100

krishnadas@aravind.org