Posters

A novel Hyper-CL™ lens for the Treatment of Bacterial keratitis. Multi-center randomized control trial

Poster Details

First Author: O.Daphna ISRAEL

Co Author(s):    Y. Kesht   M. Ben-Ishai                 

Abstract Details

Purpose:

The study objective is to evaluate the efficacy and safety of treatment with Hyper-CL™ lens + Antibiotics compared with treatment with Antibiotics only in subjects with Bacterial keratitis. The Hyper-CL™ lens is specially designed to increase contact time of any drop applied to the eye surface by trapping it between the contact lens and corneal surface for a prolonged time .

Setting:

Multi-center ongoing trail

Methods:

This study is a prospective, randomized two-arms open-label study. 10 subjects were equally allocated (with a 1:1 ratio) to one of the following 2 groups based on a randomization scheme: Treatment Group 1: Conventional treatment of topical Antibiotics+ Hyper-CL lens Treatment Group 2: Conventional treatment with topical Antibiotics alone The bacterial severity score included the following criteria: Average length of infiltration, Average of epithelial defect, Corneal thinning, Cell in AC and Corneal clarity. Effectiveness was assessed by measuring bacterial keratitis severity score over time following treatment.

Results:

Up to date a total of 10 patients included in our initial study and finished 14 days of follow-up. The baseline severity was almost equal between the two treatment groups (11.2 (SD:2.05), 11.4 (SD: 4.39) respectively). At day 14 there was a trend for better severity score for the treatment group 1-Hyper-CL™ lens (5.2 (0.45), 8.6(4.7)). There were no adverse events for both groups during the follow-up period

Conclusions:

This is the first pre-laminar results of our study evaluating the safety and efficacy of The Hyper-CL™ lens in bacterial keratitis. Based on our first descriptive results we conclude that the Hyper-CL™ lens can be used to alleviation of corneal bacterial keratitis and relieve pain in subjects with corneal keratitis.

Financial Disclosure:

receives consulting fees, retainer, or contract payments from a competing company, research is funded, fully or partially, by a competing company