JPRN-jRCT2052210025
Completed
Phase 2
Exploratory clinical trial to evaluate the safety of C-BAC1423 soft contact lens
akamura Kikue0 sites10 target enrollmentMay 13, 2021
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Myopia, Discomfort when wearing SCL due to eye allergic symptoms
- Sponsor
- akamura Kikue
- Enrollment
- 10
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion 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
Exclusion 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
Outcomes
Primary Outcomes
Not specified
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