Clinical trial for the safety and efficacy of MEL-01 soft contact lens

JRCT ID: jRCT2052240055

Registered date:10/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients with refractive errors who have been determined to be eligible for soft contact lenses
• Date of first enrollment: 06/06/2024
• Target sample size: 63
• Study type: Interventional
• Intervention(s): Subjects wear the test lenses for at least 13 weeks from the start of use (until the final visit)

Outcome(s)

• Primary Outcome: Total incidence rate of lens discontinuation

Key inclusion & exclusion criteria

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

Include criteria

(1) Refractive error (spherical equivalent: -1.00D to -7.00D)
(2) Astigmatism power: -1.50D or less
(3) Best corrected visual acuity with spectacles: 1.0 or better in each eye
(4) Patients who are able to participate in scheduled visits
(5) Patients who habitually wear soft contact lenses
(6) Age 18 or older at the time of consent acquisition *Gender does not matter
(7) Understood the content of the trial and be able to give written informed consent by their freewill

Exclude criteria

(1) Patients with moderate or higher corneal, conjunctival, or eyelid findings (findings of * or higher in the slit-lamp microscopy evaluation criteria table are considered moderate or higher findings)
(2) Patients with uveitis
(3) Patients with dry eye and lacrimal disorders that cause problems with lens wearing
(4) Patients with allergic disease to a degree that affects lens wearing
(5) Patients with diabetes
(6) Patients with a history of anaphylaxis
(7) Patients with complications considered unsuitable for the clinical trial; such as serious heart, liver, kidney, lungs, blood disorders, etc.
(8) Patients who have participated in other clinical trials (including all areas) within the past 3 months and received (used) investigational drugs or are currently participating in another clinical trial within the past 3 months, or patients who are planning to participate in another clinical trial during the course of this trial.
(9) Pregnant or lactating women or patients who may be pregnant, patients who wish to become pregnant from the time of consent to the end of clinical trials, patients who do not consent to contraception from the time of consent to the end of the clinical trials
(10) Patients who are always in a dry environment (such as working in refrigerated warehouses)
(11) Patients in an environment where dust and chemicals can easily get into the eyes (workers in places with a lot of dust such as ironworks and road construction, and people who handle chemicals in experiments, etc. However, those who are working with safety glasses (goggles) are excluded. )
(12) Patients who habitually wear RGP lenses
(13) Patients with a history of refractive surgery
(14) Patients with experience wearing orthokeratology lenses
(15) Patients using monovision correction or patients who wear contact lenses for only one eye
(16) Patients who are judged by the investigator or subinvestigator to be ineligible for the study, or who are judged by the investigator or subinvestigator to be inadequate for wearing this investigational device due to poor fitting, etc.

Related Information

• Primary Sponsor: Nakamura Kikue