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A clinical trial to study the effects of the Fixed Vs Unfixed Combination of Latanoprost and Timolol in Patients of Open-Angle Glaucoma and Ocular Hypertension

A Randomized, Open-Label, Parallel Comparative Trial on Efficacy and Safety of the Fixed Vs Unfixed Combination of Latanoprost and Timolol in Patients of Open-Angle Glaucoma and Ocular Hypertension Insufficiently Controlled on Timolol and Latanoprost Monotherapy.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/03/012724
Enrollment
80
Registered
2018-03-21
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- Primary Open Angle Glaucoma and Ocular Hypertension

Interventions

Intervention1: FIXED COMBINATION OF LATANOPROST AND TIMOLOL: Group I : Fixed combination eye drops of latanoprost (0.005%) and timolol (0.5%), once a day, in the dose of 1 drop at 9 pm [LTFC]. Control

Sponsors

Government Medical College Jammu
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients 18 years of age of either sex with primary open angle glaucoma or ocular hypertension. Patients receiving either latanoprost 0.005% once daily or either timolol 0.5% once or twice daily in the preceding four weeks. Patients with IOP >21 mmHg not controlled with prior monotherapy of latanoprost or timolol.

Exclusion criteria

Exclusion criteria: Patients with age Patients with acute angle closure glaucoma Patients with hypersensitivity to either of the two drugs. Patients having co-morbid conditions like CHF, history of conduction defect or cardiogenic shock, heart block, COPD/asthma, angina, acute/uncontrolled medical or psychiatric illness, pregnancy/lactation, ocular inflammation/ocular infection and myasthenia gravis. Patients with normotensive glaucoma.

Design outcomes

Primary

MeasureTime frame
â?¢ Measurement of intraocular pressure: Intraocular pressure (IOP) was recorded with the help of a non-contact tonometer (air-puff tonometer). Three IOP readings were recorded each time and mean of three readings was used for analysis â?¢ Measurement of visual acuity: ï?? For Distant Vision: Visual acuity was measured with Snellenâ??s chartTimepoint: 2 4 6 12 weeks—

Secondary

MeasureTime frame
Cardiovascular Pulse rate Blood pressure and ElectrocardiographyTimepoint: 2 4 6 12 weeks—

Countries

India

Contacts

Public ContactRohini Gupta

Government Medical College Jammu

drbrijmohangupta18@yahoo.com9419144718

Outcome results

None listed

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