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A study to understand the Effect of Brimonidine and Timolol eye drops in patients with Eye disease

Tolerability and Effectiveness of Fixed Dose Combination (FDC) of Brimonidine (0.15 percent) plus Timolol (0.5 percent) compared to FDC of Brimonidine (0.2%) plus Timolol (0.5%) in Patients with Open Angle Glaucoma or Ocular Hypertension, A Real World Retrospective Study from Electronic Medical Records (BRIGHT Study) - BRIGHT Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/08/093627
Enrollment
262
Registered
2025-08-25
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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: Nil: Nil Intervention2: Nil: Nil

Sponsors

Sun Pharma Laboratories Limited (SPLL)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female patients more than and equal to 18 years of age 2. Patients diagnosed with primary open angle glaucoma or ocular hypertension (IOP more than and equal to 22 mmHg) by treating ophthalmologist 3. Best corrected visual acuity of 20/100 or better in each eye 4. Patients who were prescribed FDC of brimonidine (0.15% or 0.2%) plus timolol (0.5%) and completed at least 12 weeks of treatment

Exclusion criteria

Exclusion criteria: 1. Use of ocular medication other than periodic use of artificial tears 2. Functionally significant visual field loss 3. Uncontrolled systemic disease or other active ocular disease 4. Patients with incomplete medical records with respect to the required study parameters 5. Pregnant or lactating females

Design outcomes

Primary

MeasureTime frame
Proportion of patients with adverse events (AEs) and serious AEs (SAEs) during study periodTimepoint: Baseline to End of Study—

Secondary

MeasureTime frame
Percentage change in IOPTimepoint: 4?2, 8?2, & 12?2 weeks;Proportion of patients achieving IOP less than & equal to 21 mmHgTimepoint: 4?2, 8?2, & 12?2 weeks;Response to treatment graded by patients (satisfied, not satisfied, no response)Timepoint: Baseline to End of Study—

Countries

India

Contacts

Public ContactMs Colette Pinto

Sun Pharma Laboratories Limited

Neeraj.Markandeywar@sunpharma.com02243244324

Outcome results

None listed

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