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A Phase III Multinational Multicenter Investigator-Masked Randomised Active-Controlled Trial Comparing the Efficacy and Safety of DE-130A With Xalatan® in Patients With Open-Angle Glaucoma or Ocular Hypertension

2019-10-24 12:49:26 | BioPortfolio

Summary

A Phase III, Multinational, Multicenter, Investigator-Masked, Randomised, Active-Controlled Trial, comparing the efficacy and safety of DE-130A with Xalatan® in Patients with Open-Angle Glaucoma or Ocular Hypertension over a 3-Month period, followed by a 12-Month Follow-Up with Open-Label DE-130A Treatment

Description

Phase III, prospective, interventional, multinational, multicentre, investigator-masked, randomised, active-controlled trial

Study duration:

- 5 days to 5-week washout period

- 15 months for the first 130 patients

- 12 weeks for the next 250 patients

Patients will attend 6 visits following the wash-out phase (up to 5 weeks):

- Period 1 (3-month investigator-masked treatment period, DE-130A vs Xalatan®): Randomisation/Baseline visit (Day 1), Week 4 (±3 days) and Week 12 (±3 days)

- Period 2 (12-month follow-up from Week 12, open-label DE-130A treatment for the first 130 patients who complete their week 12 visit and agree to participate in the open-label period of the study): Month 6 (± 7days), Month 9 (±7 days) and Month 15 (± 1 week) visits.

Study Design

Conditions

Open-Angle Glaucoma or Ocular Hypertension

Intervention

DE-130A, Xalatan®

Location

Hôpital des XV-XX
Paris
Île-de-France
France
75012

Status

Recruiting

Source

Santen SAS

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-24T12:49:26-0400

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