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

NCT04133311 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 386

Last updated 2024-05-28

Study results available
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Summary

A Phase III, Multinational, Multicenter, Investigator-Masked, Randomized, 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.

Conditions

  • Open-Angle Glaucoma or Ocular Hypertension
  • Ocular Surface Disease

Interventions

DRUG

DE-130A

Latanoprost 50 microg/ml eye drops emulsion, preservative-free eye drops emulsion in single-dose containers.

DRUG

Xalatan®

Latanoprost 50 microg/ml eye drops solution, eye drops in 2.5 ml dropper containers.

DRUG

DE-130A/DE-130A

After Week 12, received DE-130A continuously.

DRUG

Xalatan®/DE-130A

From week 12 onwards, DE-130A was continued to be administered instead of Xalatan®.

Sponsors & Collaborators

  • Santen SAS

    lead INDUSTRY

Principal Investigators

  • Jean-Sebastien Garrigue, PhD · Santen SAS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-10
Primary Completion
2022-02-03
Completion
2022-10-26

Countries

  • France

Study Locations

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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 NCT04133311 on ClinicalTrials.gov