Placebo-Controlled, Parallel-Group Study of KRP-KC121E in Patients with Meibomian Gland Dysfunction

JRCT ID: jRCT2031220407

Registered date:24/10/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Meibomian Gland Dysfunction
• Date of first enrollment: 10/11/2022
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Eye instillation of KRP-KC121E or placebo to patients with Meibomian Gland Dysfunction

Outcome(s)

• Primary Outcome: Improvement in inflammation, adverse events etc.
• Secondary Outcome: Improvement in inflammation

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

-Aged over 18 years at the time of Informed Consent(any gender)
-Live in Japan
-Have Meibomian Gland Dysfunction in both eyes
-Meet the other protocol-specified inclusion criteria

Exclude criteria

-Unable to discontinue wearring contact lens during the study
-Have history of, or scheduled ocular surgery during the study
-Have active ocular disease
-Have severe systemic illness
-Known history of hypersensitivity to any of the drugs used in the study
-Patient who is pregnant, lactating, potentially pregnant
-Have judged that it is inappropriate to participate in this study by investigator
-Meet the other protocol-specified exclusion criteria

Related Information

• Primary Sponsor: Omatsu Kazunori