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A clinical study to confirm the efficacy and safety of hard contact lenses for vision correction (SS-200)

A clinical study to confirm the efficacy and safety of hard contact lenses for vision correction (SS-200)

Miyazaki Jiro

SUN CONTACT LENS Co.,Ltd.

46-1, Chudoji Shonouchi-cho, Shimogyo-ku, Kyoto-city, Kyoto

ss-miyazaki@sun-con.co.jp

Miyazaki Jiro

SUN CONTACT LENS Co.,Ltd.

46-1, Chudoji Shonouchi-cho, Shimogyo-ku, Kyoto-city, Kyoto

+81-75-315-3221

ss-miyazaki@sun-con.co.jp

Recruiting

Aug. 01, 2026

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1) Subjects with corneal astigmatism in the target eye who cannot achieve a decimal visual acuity of 0.7 or higher with glasses or existing soft contact lenses and who have difficulty in using existing hard contact lenses due to a foreign body sensation, eye pain, or displacement or fallout of the lens
2) Subjects whose best-corrected visual acuity with glasses in the target eye at the initial visit is a decimal visual acuity of 0.01 or higher
3) Subjects who are judged to be eligible for wearing contact lenses in the opinion of the investigator or the subinvestigator
4) Subjects aged 18 years or older who understood the purpose of the study and voluntarily signed the consent form
5) Subjects who are able to undergo routine medical examinations and follow the instructions and directions of the investigator or the subinvestigator

1) Subjects who have worn scleral lenses
2) Subjects who have a history of allergy after using existing soft contact lenses, existing hard contact lenses, or contact lens care products
3) Subjects who have turbidity, etc., in the visual field due to corneal stromal opacity, etc., and for whom the effect of vision correction by contact lenses, etc., cannot be expected in the opinion of the investigator or the subinvestigator
4) Subjects who currently require glaucoma treatment such as eye drops
5) Subjects who are judged to be inappropriate for wearing contact lenses in the opinion of the investigator or the subinvestigator due to ongoing treatment (e.g., eye drops), etc., after corneal surgery
6) Subjects who have acute or subacute inflammation in the anterior segment of the eye (e.g., bacterial, fungal, or viral keratitis, autoimmune corneal ulcer, conjunctivitis, and scleritis)
7) Subjects who have infection in the anterior segment of the eye (e.g., eyelid infection, conjunctival infection, and corneal infection)
8) Subjects who have uveitis (iritis, uveitis other than that in the iris)
9) Subjects with any retinal disease
10) Subjects with a damaged surface in the anterior segment of the eye
11) Subjects with cataracts that may affect visual acuity
12) Subjects with progressive keratoconus
13) Subjects in whom intraocular pressure exceeds the value specified in the protocol at the initial visit
14) Subjects in whom the corneal endothelial cell count is below the value specified in the protocol at the initial visit
15) Subjects with decreased corneal sensation
16) Subjects with eyelid abnormality
17) Subjects with serious lacrimal fluid abnormality

Other subjects who meet the exclusion criteria specified in the protocol

Both

Corneal astigmatism

- Daily wear: Wear after waking up and remove before going to bed.
- Wearing time: Wearing for the subject's preferred time within the range instructed by the physician.
- Wearing method: When wearing, use the wetting solution specified separately.

Other details shall be specified in the protocol

Change in the best-corrected visual acuity (logMAR) by correction of SS-200 at Week 13 from best-corrected visual acuity (logMAR) with glasses at the initial visit

+81-42-648-5551

July. 30, 2026

No

None

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