Open-label exploratory study to evaluate the efficacy of Ocuring for dry eye

JRCT ID: jRCTs012240029

Registered date:23/08/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Dry eye
• Date of first enrollment: 23/08/2024
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Employing unapproved medical device

Outcome(s)

• Primary Outcome: Change in BUI to evaluate tear stability before and during Occuling wear

Secondary Outcome

(1) Tear film breakup time (BUT)
(2) Subjective symptom questionnaire (J-OSDI and DEQS)
(3) Tear secretion function (Schirmer test)
(4) Tear meniscus

Key inclusion & exclusion criteria

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

Include criteria

(1) Subjects with dry eye symptoms such as eye discomfort or abnormal visual function or tear break-up time (BUT) of 5 seconds or less
*Examples of dry eye symptoms: dazzling, foreign body sensation, eye pain, dry eye, blurred vision, difficulty in seeing
(2) Men and women who are 18 years of age or older at the time of obtaining consent
(3) For contact lens wearers, those who can stop wearing contact lenses from 2 days prior to Ocuring wear until the end of wear.
(4) Subjects who can provide written informed consent of their own free will after receiving sufficient explanation and have sufficient understand regarding their participation in this study.

Exclude criteria

(1) Women who are pregnant or breastfeeding
(2) Those who are unable to stop wearing contact lenses during the research period (spectacles are acceptable)
(3) Those who are judged to be ineligible as subjects of this study by the investigators

Related Information

• Primary Sponsor: Kijima Riki
• Source(s) of Monetary Support: SEED Co., Ltd.