NCT03888378

Study to Evaluate the Safety and Efficacy of Minocycline Ointment in Subjects With Inflamed Meibomian Gland Dysfunction

A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled Study of the Efficacy and Safety of HY02 Ointment in Subjects With Inflamed Meibomian Gland Dysfunction

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 270 (actual)
• Sponsor: Hovione Scientia Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of two strengths of HY02 Ointment versus Vehicle administered twice daily for twelve weeks in subjects with a diagnosis of Inflamed Meibomian Gland Dysfunction.

Conditions

• Meibomian Gland Dysfunction
• MGD-Meibomian Gland Dysfunction

Interventions

Type	Name	Description
DRUG	0.3% Topical Minocycline Ointment	0.3% Topical Minocycline ointment to treat inflamed Meibomian Gland Dysfunction
DRUG	1% Topical Minocycline Ointment	1% Topical Minocycline ointment to treat inflamed Meibomian Gland Dysfunction
OTHER	Topical Vehicle Ointment	Topical vehicle ointment to treat inflamed Meibomian Gland Dysfunction

Timeline

• Start date: 2019-04-02
• Primary completion: 2020-09-18
• Completion: 2021-02-01
• First posted: 2019-03-25
• Last updated: 2021-03-05

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated drug study