Clinical trial for the efficacy of C-BAC1423 soft contact lens
- Conditions
- SCLs wearers with eye allergies
- Registration Number
- JPRN-jRCT2032230321
- Lead Sponsor
- akamura Kikue
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 66
1) Refractive error (spherical power: -1.00D to -6.00D)
2) Patients without ocular itching, bulbar conjunctival hyperemia, or palpebral conjunctival hyperemia in both eyes while wearing SCLs before antigen challenge. Except for transient symptoms at Visit 1.
3) Patients with allergic reactions in both eyes after confirmation of CAC reactions
4) Patients with a history of allergic conjunctivitis,and are positive for cedar pollen by antigen-specific IgE antibody test
5) Best corrected visual acuity: equal or better than 0.7 in each eye
6) Agreed to participate as an outpatient
7) Habitual soft contact lens wearers who can wear SCL not less than 8 hours per day
8) Age 18 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
1) Patients with allergic symptoms to antiallergic agents
2) Patients with symptoms or findings such as allergic symptoms after instillation of the antigen control solution at Visit 2
3) Patients with eye disease requiring treatment other than refractive error and allergic conjunctivitis
4) Patients with dry eye and lacrimal disorders that cause problems with lens wearing
5) Patients who are not able to stop using eye drops other than artificial tears while wearing test lenses at Visit4 and Visit5
6) Patients who have systemic administration of anti-allergic drugs, histamine H1 receptor antagonists, non-steroidal anti-inflammatory drugs, and vasoconstrictor that are prohibited concomitant drugs, within 7 days before the start of Visit 1 (excluding treatment after antigen challenge)
7) Patients using prohibited concomitant drugs (systemic corticosteroids, eye ointments, subconjunctival injections) within 28 days before the start of Visit 1 (excluding treatment after antigen challenge)
8) Patients who are not able to stop using other drug-containing contact lenses during the study period, and patients who are not able to stop using other contact lenses other than the investigational device at Visits 4 and 5
9) Patients with a history of anaphylaxis to sodium cromoglycate
10) Patients with complications considered unsuitable for the clinical trial; such as serious heart, liver, kidney, lungs, blood disorders, etc.
11) Patients who have participated in other clinical trials (including all areas) within the past 3 months and received (used) the investigational drug, etc., patients participating in other trials, patients planning to participate in other trials during this study period
12) 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
13) Patients who are always in a dry environment (such as working in refrigerated warehouses)
14) 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. )
15) Patients who wear RGP lenses within 14 days before the start of Visit 1
16) Patients who are judgeed to be not eligible for the clinical trial by the investigators.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method