NCT04133311

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

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 386 (actual)
• Sponsor: Santen SAS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Phase III, prospective, interventional, multinational, multicentre, investigator-masked, randomized, 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®): Randomization/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.

Conditions

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

Interventions

Type	Name	Description
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®.

Timeline

• Start date: 2019-04-10
• Primary completion: 2022-02-03
• Completion: 2022-10-26
• First posted: 2019-10-21
• Last updated: 2024-05-28
• Results posted: 2024-05-28

Locations

1 site across 1 country: France