Novel drug-repository contact lens for prolonging the antimicrobial-cornea interaction for bacterial keratitis treatment: randomised controlled trial results

BACKGROUND/AIMS: Microbial keratitis can cause unilateral blindness, but the drug delivery treatment options are poor. Therefore, this study evaluated the efficacy of a novel therapeutic drug-depository contact lens (DDCL) for bacterial keratitis (BK) treatment. The lens was designed to increase the corneal lesion-antimicrobial drug interaction time. METHODS: Patients with BK were randomised (1:1) into two groups: topical antimicrobial treatment only (group 1) and DDCL plus antimicrobial treatment (group 2). Both groups received 0.5% moxifloxacin. We evaluated BK recovery, anterior chamber (AC) reactions, corneal haze and pain (on a 10-point scale) 12 hours and 1, 3, 5 and 14 days after treatment. RESULTS: The baseline corneal-infiltration (ie, BK severity) values were comparable for groups 1 (18 cases) and 2 (17 cases) (p=0.92). After 12 hours, the scores improved in both groups and continued to improve throughout the follow-up period; the improvements were more pronounced in group 2 than in group 1 (all p<0.05). Complete recovery occurred on days 14 and 5 in groups 1 and 2, respectively. Furthermore, the AC reaction resolved by day 3 in group 2. The baseline pain scores were also comparable between groups 1 and 2 (p=0.52) and decreased throughout the follow-up period (all p<0.05); the decrease was more pronounced in group 2. CONCLUSIONS: Novel DDCLs augment the drug-lesion interaction time by prolonging corneal antimicrobial availability, which hastens corneal healing in BK. Thus, a DDCL may decrease the antibiotic regimen and improve patient tolerance, eliminating the necessity for a loading dose. TRIAL REGISTRATION NUMBER: CTRI/2020/08/027088.