Clinical trials to evaluate the efficacy and safety of Scleral contact lens,OPS01

JRCT ID: jRCT2032230323

Registered date:04/09/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Corneal astigmatism that cannot use existing RGP contact lenses and soft contact lenses.
• Date of first enrollment: 04/09/2023
• Target sample size: 25
• Study type: Interventional
• Intervention(s): Subjects wear the test contact lense for 13 weeks.

Outcome(s)

• Primary Outcome: Change value of bestcorrected visual acuity at before CL fitting and at after 13weeks use of test contact lense(OPS01).

Secondary Outcome

- Improvement rate: Percentage of respondents showing a decrease of 0.2 or more in logMAR.
- Change over time in best-corrected visual acuity with test contact lenses correction.
- Change in subjective symptoms.
- Wearing time of test contact lenses.
- Change severity of pain and dryness in the eye.

Key inclusion & exclusion criteria

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

Include criteria

1) 18 years of age or older at the time consent acquisition.
2) The patient with corneal astigmatism in the objective eye that prevents the use of RGP contact lenses due to foreign body sensation, eye pain, or lens dropout.
3) Corneal astigmatism (keratoconus, pericyte corneal degeneration, post surgical, etc.) that cannot be corrected by either glasses or soft contact lenses (visual acuity of 0.7 or better) in the objective eye.
4) The best corrected visual acuity of the subject eye at the time of screening is between 0.01 and 0.7.

Exclude criteria

1) Existing vision correction methods (glasses, soft contact lenses, RGP contact lenses, etc.) are able to correct vision to 0.7 or better (fractional visual acuity) in the objective eye and provide satisfactory results with no problems in terms of wearing comfort.
2) Patients with a history of allergic reactions to soft or RGP contact lenses or to the contents of contact lens care products.
3) Patients with a history of corneal transplantation in the objective eye.
4) Patients with corneal opacity in the objective eye, and the investigator determines that the corneal opacity covers the visual field area and cannot be expected to be corrected by a vision correction device.
5) Patients with a history or suspected history of glaucoma in the objective eye.
6) Patients with acute or subacute inflammation or infection in the anterior eye as described below
- Bacterial, fungal or viral keratitis
- Autoimmune corneal ulcer
- Conjunctivitis
- Scleritis
7) Patients with hyperemia, inflammation, or eye pain in the anterior eye other than those indicated in 6), which is judged by the investigator or subinvestigator to interfere with the use of the investigational device.
8) Patients who are participating or planning to participate in other clinical trials.
9) Patients who are judged by the investigator to be ineligible for this clinical trial.

Related Information

• Primary Sponsor: Tasaka Tetsuya