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

Determination Of Predictive Factors Allowing To An Additional 10% Reduction Of Intra-Ocular Pressure After A 12-Week Treatment With Latanoprost 0.005% / Timolol 0.5% Fixed Combination (Xalacom) In Previously Treated Patients With Open Angle Glaucoma Or Ocular Hypertension

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00230763

Acronym

PREDICOM

Enrollment

396

Registered

2005-10-03

Start date

2005-09-30

Completion date

2007-10-31

Last updated

2021-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma, Primary Open Angle (POAG), Ocular Hypertension

Brief summary

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).

Interventions

PROCEDUREGSS questionnaire

D0, D30 and D84

PROCEDUREIOP

D0, D30 and D84

DRUGLATANOPROST 0.005% / TIMOLOL 0.5% FIXED COMBINATION

in the evening during 84 days

PROCEDUREVisual acuity

D0 and D84

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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,

Design outcomes

Primary

Measure	Time frame
A positive response defined as an additional IOP reduction over 10% after 12 weeks of treatment in the intent to treat (ITT) population.	after 12 weeks of treatment

Secondary

Measure	Time frame
Absolute and relative IOP change after 4 and 12 weeks of treatment	week 4 and 12
Percentage of patients achieving a target IOP value: under 18 mmHg and under 16 mmHg after 12 weeks of treatment,	week 12

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026