CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 386 enrolled
Drug / intervention
DE-130A +3 moredrug
Likely dose
Xalatan® 2.5 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04133311
NCT04133311Phase 3Completed

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.

Santen SAS·interventional·Posted Oct 21, 2019·Updated May 28, 2024

In Brief

A Phase 3 clinical trial evaluating DE-130A, Xalatan®, and 2 other interventions for Open-Angle Glaucoma or Ocular Hypertension and Ocular Surface Disease. Completed, enrolled 386 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedOct 21, 2019
Enrollment StartApr 10, 2019
Primary CompletionFeb 3, 2022
Study CompletionOct 26, 2022
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 6.7 years ago

Interventions

DE-130Adrug

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

Xalatan®drug

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

DE-130A/DE-130Adrug

After Week 12, received DE-130A continuously.

Xalatan®/DE-130Adrug

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