Phase 3 efficacy and safety study of CPL0702 as compared to dorzolamide and brimonidine in glaucoma and ocular hypertension.

A multicenter, open label, randomized, active controlled, comparative, parallel group, phase 3 non-inferiority, clinical study to evaluate efficacy and safety of CPL0702 ophthalmic solution versus dorzolamide 2 percentage ophthalmic solution and brimonidine 0.1 percentage ophthalmic solution given concurrently in subjects with primary open angle glaucoma (POAG) or ocular hypertension (OHT). - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/05/109959

Enrollment

266

Registered

2026-05-04

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

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: FDC Dorzolamide 2% plus Brimonidine 0.1% ophthalmic solution: One drop every day twice daily for 84 days Control Intervention1: Dorzolamide 2% ophthalmic solution and Brimonidine 0.1% o

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects/LAR willing and able to provide informed consent 2. Subjects of either gender of 18 to 75 years (both inclusive) 3. Subjects with diagnosis of primary open angle glaucoma or ocular hypertension in one or both eyes insufficiently controlled on monotherapy or being treated with multiple IOP lowering medications with IOP of greater than 24 to less than or equal to 36 mmHg confirmed by Goldmann applanation tonometry 4. Subjects with best corrected visual acuity equivalent plus 0.7 logMAR units (or Snellen equivalent of approximately 20 by 100 or ETDRS) or better in at least one eye

Exclusion criteria

Exclusion criteria: 1. History of hypersensitivity to carbonic anhydrase inhibitors, alpha adrenergic agonist or sulphonamide derivatives or any of its components. 2. Subjects with cup-to disc ratio greater than 0.80 (horizontal or vertical measurement) or split fixation in either eye or with severe central visual field loss in either eye; severe central visual field loss was defined as a sensitivity of less than or equal to 10 dB in at least 2 of the 4 visual field test points closest to the point of fixation. 3. Subjects with history of chronic, recurrent, or current severe inflammatory eye disease (i.e., scleritis, uveitis, herpes keratitis) in either eye. 4. Subjects with history of ocular infection or ocular inflammation within the preceding 3 months.

Design outcomes

Primary

Measure	Time frame
Mean change in the mean diurnal IOP from the baseline to the end of 12 weeks (Day 84).Timepoint: Mean of 3 time points 9AM, Plus 2-hour, Plus 7-hour from the baseline to the end of 12 weeks (Day 84)	—

Secondary

Measure	Time frame
Difference between two groups in mean change in the IOP at 3 time points Difference between two groups in subject satisfaction score on scale of 1 to 5 Difference between two groups in mean change in the mean diurnal IOP Percentage reduction in the mean diurnal IOP Incidences of AE and SAETimepoint: Baseline to week 2, 6 and 12 weeks	—

Countries

India

Contacts

Public ContactMr Rahul Namjoshi

Cipla Limited

sandesh.sawant3@cipla.com02223025006

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026