NCT04391894

A Study to Assess the Safety and Efficacy of ECF843 vs Vehicle in Subjects With Dry Eye Disease

A Randomized, Double-masked, Multicenter Study to Evaluate the Safety and Efficacy of ECF843 vs Vehicle in Subjects With Dry Eye Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 718 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study was planned to be conducted in 2 parts: Part 1 to determine the efficacy and safety of ECF843 vs vehicle, followed by Part 2 with additional exploratory assessments of ECF843 vs Vehicle. Both parts of the study included a double-masked study design, with randomization stratified for subjects with Sjogren's Syndrome.

Detailed description

Part 1 of the study was a double-masked, randomized, parallel design in which participants were assigned to one of the following five treatment arms/groups in a ratio of 1:1:1:1:1. * ECF843 0.45 mg/mL three times daily (TID) or vehicle * ECF843 0.15 mg/mL TID or vehicle * ECF843 vehicle TID * ECF843 0.15 mg/mL twice daily (BID) or vehicle * ECF843 vehicle BID The planned duration of double-masked treatment during Part 1 was 56 days. For subjects randomized to ECF843, the maximum drug exposure was up to 28 days. At some point during Part 1, all participants received vehicle. The study was terminated after completion of Part 1 and Part 2 of the study was not therefore initiated.

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	ECF843	Topical ocular eye drop
OTHER	ECF843 vehicle	Topical ocular eye drop

Timeline

• Start date: 2020-10-06
• Primary completion: 2021-05-13
• Completion: 2021-05-13
• First posted: 2020-05-18
• Last updated: 2025-01-28
• Results posted: 2022-05-26

Locations

52 sites across 1 country: United States

Regulatory

• FDA-regulated drug study