Dr. Debarun Dutta is a lecturer at the Aston University, Birmingham, UK. Prior to this, Debarun was a research fellow at the School of Optometry and Vision Science, University of New South Wales, Australia. Debarun completed his PhD in the development of antimicrobial contact lenses at the Brien Holden Vision Institute. His research interests include contact lenses and dry eye, ocular adverse events, and novel antimicrobial agents.
This paper was originally shared at the American Academy of Optometry (AAO) annual meeting, 2018.
Authors: Debarun Dutta, Kalaiselvan Parthasarathi, Nagaraju Konda, Savitri Sharma, Pravin Vaddavalli, Fiona Stapleton, Mark Willcox
Purpose: Contact lens-induced corneal infiltrative events (CIEs) occur with soft contact lens wear. Preventing and reducing these events remains a challenge for practitioners and industry. The aim of this study was to evaluate the incidence and type of CIEs seen with bi-weekly hydrogel antimicrobial contact lens wear compared with a control lens over three months of extended wear.
Methods: A prospective, randomized, double-masked, contralateral, extended contact lens wear clinical trial was conducted with 176 subjects. The study received ethics approval (HREC#15436) and was registered with Australia and New Zealand Clinical Trial Registry (ACTRN1261500072556). Antimicrobial contact lenses were produced by coating with Mel4 (Melimine) peptide as reported previously. Subjects were 18-42 years of age (22.6 ± 4.2) and had refractive errors ranging from a -0.75 dioptre (D) sphere to a -6.50D sphere with a cylinder ≤ -1.50D. The contact lenses were removed and replaced at 14-day intervals over a period of three months. Follow-up visits were conducted after one-night, two-weeks, one-month and three-months of lens wear, including a non-lens wear follow-up after one-month of discontinuing the lens wear. The main outcome measures were the incidences of CIEs per 100 eye-months and rate of discontinuations.
Results: A total of one hundred and thirty-five subjects completed the study; 73% were neophytes. Microbial keratitis did not occur. Nine CIEs were seen, three with Mel4-coated lens wear (0.7 events per 100 eyes per month) and six with control lens wear (1.3 events per 100 eyes per month; p=0.508). With the Mel4-coated lens, the incidence of contact lens-induced acute red eye (CLARE) and infiltrative keratitis (IK) was 0.4 and 0.2 events per 100 eyes per month respectively. A total of 14.2% participants dropped-out from the study; 5.1% due to general health issues such as fever, chickenpox, and hypothyroidism, 5.1% were not interested in continuing in the study, 2.8% had bilateral ocular discomfort with contact lens wear and 2.3% relocated to other cities.
Conclusion: Mel4-coated (Melimine peptide) antimicrobial contact lenses reduced the incidence of CIEs by 50% during two weeks extended hydrogel contact lens wear, but this did not reach statistical significance due to the low rate of CIEs generally in this population.