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Efficacy and Safety Assessment of T2347 Versus Xalacom® in Ocular Hypertensive or Glaucomatous Patients

NCT02278614 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2017-04-28

Study results available
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Summary

The objective of the study is to assess the efficacy and safety of T2347 (Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops) versus Xalacom® in ocular hypertensive or glaucomatous patients initially treated, stabilised by Xalacom® or generics (fixed combination Latanoprost 0.005% + Timolol 0.5% preserved eye drops).

Conditions

Interventions

DRUG

T2347

T2347 eye drop solution is presented in SDU. It is supplied in 0.20 ml single use polyethylene containers.

DRUG

Xalacom

Xalacom® 0.01% eye drop solution is supplied in 2.5 ml multidose container.

Sponsors & Collaborators

  • Laboratoires Thea

    lead INDUSTRY

Principal Investigators

  • Ingeborg Stalmans, Professor · Head of the Glaucoma Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02278614 on ClinicalTrials.gov