Effect of Eye Wash solution on Contact Lens Discomfort (CLD)

UMIN ID: UMIN000054676

Registered date:19/06/2024

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Healthy volunteers
• Date of first enrollment: 2024/02/06
• Target sample size: 22
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Eyebon mild
Saline solution

Outcome(s)

• Primary Outcome: 1: Evaluation of J-CLDEQ-8 scores
• Secondary Outcome: 2: Evaluation of conjunctival vascular occupancy 3: Evaluation of noninvasive interferometry break up time 4: Evaluation of mucin content in tear fluid 5: Evaluation of tear fluid volume 6: Determination of the amount of total protein adhered to contact lenses

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 60years-old
• Gender: Male and Female
• Exclude criteria: 1.Subjects diagnosed with ocular Xerophthalmia(dry eye syndrome) 2.Subjects who have experienced adverse reactions such as skin rash, redness, itching, redness of the skin, redness of the eyes, itching or swelling of the eyes due to the use of eye washes in the past 3.Subjects with severe eye pain 4.Subjects who used eye washes or eye drops outside the study during the study period 5.Subjects infected with HBV, HCV, HIV, etc 6.Subjects who the investigator considers ineligible for enrolment

Related Information

• Primary Sponsor: Kobayashi Pharmaceutical Co., Ltd.
• Source(s) of Monetary Support: Kobayashi Pharmaceutical Co., Ltd.