Clinical assessments
conjunctival
CONJUNCTIVA, SECONDARY, METAPLASIA
Corneal and conjunctival staining scores at 12 weeks were defined as the primary efficacy endpoints, and those at 4 weeks were defined as the secondary efficacy endpoints. Additionally, the Schirmer I, TBUT, and OSDI scores at 4 and 12 weeks were considered secondary efficacy endpoints. The changes in CIC metaplasia and goblet cell density grades from baseline to 12 weeks were evaluated.The OSDI score, TBUT, corneal staining, conjunctival staining, and Schirmer I test value were assessed in order by a single investigator (S-H.C.). For TBUT evaluation, fluorescein was mixed in 15–30 mL of saline, and one drop of the solution was applied to the superotemporal conjunctiva. The average of three TBUT values was evaluated with cobalt blue lightOcular staining scores, including corneal and conjunctival staining scores, were determined following the Sjögren’s International Collaborative Clinical Alliance registry ocular examination protocolFor the Schirmer I test, Schirmer strips (Eagle Vision, Memphis, TN, USA) were placed in the lateral one-third of the lower eyelid without anesthesia, and the wetted length was evaluated after 5 min.