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

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

21

7 men and 14 women, all healthy individuals with an average age of 42.8 years

Consent was obtained for 21 cases, 21 cases were enrolled, and 20 cases were completed. One case was discontinued.

No adverse events occurred

From Visit 1 to Visit 2, BUI 9.5 to 9.0 (p =0.49), BUT 4.9 to 7.7(p <0.01), J-OSDI 1.1 to 1.1(p =0.83), DEQS 0.9 to 0.9 (p =0.95), Tear secretion 19.5 to 20.9 (p =0.39), Tear meniscus 0.22 to 0.19 (p <0.01).

There was no significant difference in the BUI. A significant prolongation of BUT (Breakup Time), a significant reduction in the tear meniscus, and a tendency toward increased tear secretion were observed, indicating efficacy in terms of ocular surface parameters. There were also no significant differences in subjective symptoms (J-OSDI, DEQS).

June. 01, 2026

No

No plans

https://jrct.mhlw.go.jp/latest-detail/jRCTs012240029

Kijima Riki

Hokkaido University Hospital

Kita-14 Nishi-5, Kita-ku, Sapporo, Hokkaido

riki-k@med.hokudai.ac.jp

Kijima Riki

Hokkaido University Hospital

Kita-14 Nishi-5, Kita-ku, Sapporo, Hokkaido

+81-11-706-7061

riki-k@med.hokudai.ac.jp

Complete

Aug. 23, 2024

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

(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.

(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

Both

Dry eye

Employing unapproved medical device

Change in BUI to evaluate tear stability before and during Occuling wear

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

+81-11-706-7934

Feb. 02, 2024

None