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. 2023 Sep 19;2023(9):CD014791. doi: 10.1002/14651858.CD014791.pub2

jRCT2052210025.

Methods RCT, paired‐eye design
Participants Inclusion criteria: age 20 years or older; refractive error (equivalent spherical power: −1.00 D to −6.00 D); subjective symptoms with SCL wear: eye discomfort (questionnaire score of 3 to 4 in each eye), itching (over 2 points in each eye); positive allergy test within the last year; astigmatism (less than or equal to −1.50 D); BCVA equal or better than 1.0 in each eye; habitual SCL wearers
Exclusion criteria: moderate or higher corneal, conjunctival, and eyelid findings; allergic symptoms to antiallergic agents; eye diseases except for refractive error and allergic conjunctivitis; dry eye and lacrimal disorders; concomitantly prohibited drugs; history of anaphylaxis to sodium cromoglycate; previous hard contact lens use; refractive surgery; dry, high‐dust, and chemical living environments; pregnant or lactating
Interventions 2 types of daily disposable SCL (C‐BAC1423) worn at the same time (left or right eyes based on randomization) for 2 weeks
Notes: lens material is unknown. No response to an email requesting clarification from investigators
Outcomes Primary outcome:
  • Side effects and adverse events


Secondary outcomes:
  • discontinued cases: subjective symptoms, slit lamp microscopic, and lens defects

  • lens correction

  • VA

  • improvement of eye discomfort during wearing from the first visit to the second week

Notes Sponsorship source: SEED Co. Ltd.
Author's name: Kikue Nakamura
Institution: SEED Co. Ltd.
Comments: no trial results available