Dry eye with obstructive Meibomian Gland Dysfunction
Conditions
Interventions
Apply 12.5 mcg/g M136101, 25 mcg/g M136101, 50 mcg/g M136101, or placebo twice daily for 8 weeks around the upper and lower eyelid margins.
Sponsors
Nishiura Tomoyuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Patients who have provided written informed consent to participate in the clinical trial. (2)Patients who are 18 years of age or older at the time of obtaining consent. (3)Patients whose both eyes meet the following criteria 1)Diagnosed with hyposecretory Meibomian Gland Dysfunction (MGD) according to the diagnostic criteria set forth in the Meibomian Gland Dysfunction Treatment Guidelines (2023). 2)Diagnosed with dry eye according to the diagnostic criteria set forth in the Dry Eye Treatment Guidelines (2019) (4)Patients who meet all of the following criteria in the same eye during the screening visit and on Day 1 1)Continuous presence of any subjective symptoms (ocular discomfort, foreign body sensation, dryness, pressure sensation, and tearing) at both the screening visit and Day 1. 2)An average Tear film break-up time (BUT) of 5 seconds or less. 3)A count of 10 or more pluggings in the upper eyelid.
Exclusion criteria
Exclusion criteria: (1)Patients who have experienced severe allergic reactions to medications. (2)Patients who have had allergic reactions to medications containing vitamin D or vitamin D derivatives. (3)Patients who have had allergic reactions to medications used for eye examinations. (4)Patients with serious cardiac, hepatic, renal, pulmonary, hematologic, or other diseases considered inappropriate for participation in the clinical trial. (5)Patients with a corrected visual acuity* of less than 0.3 in both eyes. *Correction with contact lenses is not permitted. (6)patients with blepharospasm or who are unable to close their eyelids. (7)Patients with diseases that could potentially affect the outcome of the trial. (8)Patients who have undergone the following surgeries: 1)Vision correction surgeries, such as LASIK. 2)Corneal transplantation. 3)Surgical lacrimal punctal occlusion. (9)Pregnant women, those who may be pregnant, or those wishing to become pregnant during the trial period. (10)Patients who are breastfeeding. (11)Women who are not willing to use effective contraception during the trial period as per the physician's advice. (12)Patients who have previously participated in this clinical trial. (13)Patients who have participated in another clinical trial within the last 120 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tear film break-up time (BUT) | — |
Contacts
Public ContactClinical Trials Information -
Maruho Co.,Ltd. Kyoto R&D Center
Outcome results
None listed