NCT06400511

A Phase 3 Study to Evaluate the Efficacy and Safety of Pimecrolimus 0.3% Ophthalmic Ointment

A Randomized, Double-Masked, Vehicle-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Pimecrolimus 0.3% Ophthalmic Ointment (MR-139), in Subjects With Blepharitis

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 477 (actual)
• Sponsor: Famy Life Sciences, a Viatris Company · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to determine the efficacy and safety of Pimecrolimus 0.3% (MR-139) Ophthalmic Ointment.

Detailed description

The study is designed to evaluate Pimecrolimus 0.3% Ophthalmic Ointment in subjects with blepharitis to complete resolution (score = 0 on grading scale of 0-4) for eyelid debris after BID use at Week 6 in the Study Eye.

Conditions

• Blepharitis

Interventions

Type	Name	Description
DRUG	Pimecrolimus 0.3% Ophthalmic Ointment	Pimecrolimus 0.3% Ophthalmic Ointment will be applied twice a day to both eyelid margins.
DRUG	Placebo Ophthalmic Ointment	Placebo will be applied twice a day to both eyelid margins.

Timeline

• Start date: 2024-04-22
• Primary completion: 2025-09-09
• Completion: 2025-10-15
• First posted: 2024-05-06
• Last updated: 2026-01-07

Locations

29 sites across 1 country: United States

Regulatory

• FDA-regulated drug study