Determination Of Predictive Factors Allowing To An Additional 10% Reduction Of Intra-Ocular Pressure (PREDICOM)

Viatris

Status and phase

Completed

Phase 3

Conditions

Ocular Hypertension

Glaucoma, Primary Open Angle (POAG)

Treatments

Procedure: Visual acuity

Procedure: IOP

Drug: LATANOPROST 0.005% / TIMOLOL 0.5% FIXED COMBINATION

Procedure: GSS questionnaire

Study type

Interventional

Funder types

Industry

Identifiers

NCT00230763

A6641040

Details and patient eligibility

About

To determine the predictive factors of a positive response to latanoprost 0.005% / timolol 0.5% fixed combination (defined as a 10% IOP reduction from baseline), after 12 weeks of treatment (age, sex, ethnic origin, patient's medical history, family history of OAG or OHT, concomitant systemic treatment with beta-blockers, etiology, IOP at baseline, corneal thickness, compliance, and adverse events).

Enrollment

396 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female patients,
Aged > than equal to 18 years,
Patient presenting with an OHT or OAG with an IOP � 21 mmHg,
Patient currently treated with ophthalmic beta-blockers monotherapy and requiring a change of the ophthalmic medication due to insufficient response to treatment,

Exclusion criteria

Patient currently treated by or having received within the last month any ophthalmic hypotensive agent other than a beta-blocker,
Patient presenting any contraindication to latanoprost or timolol,
Patient with history of asthma, obstructive broncho-pneumopathy, sinusal bradycardia (pulse rate < 60 bpm), auriculo-ventricular block, cardiac insufficiency, Raynaud disease or any other condition that would preclude the patient from taking the prescribed medication,
Patient with known intolerance to benzalkonium chloride or any excipient contained in the trial treatment,