Exploratory clinical trial to evaluate the safety of C-BAC1423 soft contact lens

JRCT ID: jRCT2052210025

Registered date:13/05/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Myopia, Discomfort when wearing SCL due to eye allergic symptoms
• Date of first enrollment: 11/06/2021
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Wear two types of daily disposable contact lenses on left and right eyes based on randomization. The lenses will be worn at the same time for 2 weeks.

Outcome(s)

• Primary Outcome: Side effects and adverse events

Secondary Outcome

Discontinued cases, subjective symptoms, slit lamp microscopic findings and lens defects
Lens corrected visual acuity
Improvement of eye discomfort during wearing from the first visit to the second week

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1 Refractive error (equivalent spherical power: -1.00D to -6.00D)
2 In the subjective symptom questionnaire, eye discomfort when wearing soft contact lenses is 3 or 4 points in each eye, and itching of the eyes is over 2 points in each eye.
3 Positive allergy test within the last year
4 Astigmatism power: less than or equal to -1.50D
5 Best corrected visual acuity: equal or better than 1.0 in each eye
6 Agreed to participate in scheduled visits
7 Habitual soft contact lens wearers
8 Age 20 or older at the time of consent acquisition *Gender does not matter
9 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, and eyelid findings
2 Patients with allergic symptoms to antiallergic agents
3 Patients with eye diseases except for refractive error and allergic conjunctivitis
4 Patients with dry eye and lacrimal disorders that cause problems with lens wearing
5 Patients using concomitantly prohibited drugs (corticosteroids, antiallergic drugs, histamine H1 receptor antagonists, nonsteroidal anti-inflammatory drugs, systemic administration of immunosuppressive drugs and eye drops, and instillation of vasoconstrictor) within 7 days (within 4 weeks for oral steroids) before the start of experimental lens wear
6 Patients who are not able to stop using eye drops other than artificial tears and patients who are not able to stop using other contact lenses during the study period
7 Patients with a history of anaphylaxis to sodium cromoglycate
8 Patients with complications considered unsuitable for the clinical trial; such as serious heart, liver, kidney, lungs, blood disorders, etc.
9 Patients who have participated in other clinical trials (including all areas) within the past 3 months and received (used) of investigational drugs, etc., patients participating in other trials, patients planning to participate in other trials during this study period
10 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 treatment, patients who do not consent to contraception from the time of consent to the end of the trial
11 Patients who are always in a dry living environment (such as working in refrigerated warehouses)
12 Patients in a living 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. )
13 Habitual RGP lens wearers
14 Patients with history of corneal refractive surgery
15 Patients with experience wearing orthokeratology lenses
16 Patients wearing contact lens for one eye only
17 Patients who are judgeed to be not eligible for the clinical trial by the investigators. Patients who are judged by the investigators to be unsuitable to wear this study lens due to poor fit, etc.

Related Information

• Primary Sponsor: Nakamura Kikue