The analysis, published in the American Journal of Ophthalmology, evaluated results of a multicenter phase 1 and 2 clinical trial that tested C-KAD, an eye-drop solution developed by Livionex, according to an Oct. 3 news release. The drops seek to reverse early-stage cataracts at a point when many people begin noticing a decline in contrast sensitivity or their ability to see low-contrast images, such as street signs at night or words on a dimly lit page.
Participants in the clinical trial, which took place in 2008, used the drops or a placebo for four months. The short-term trial suggested that the drops gave some patients clearer vision. But the trial failed to show a statistically significant improvement in contrast sensitivity among participants compared to the placebo.
Over time, the drops remove heavy metals that are a factor in the accumulation of abnormal proteins in the lens. The new analysis also corrects well-documented limitations of the original vision test that was used to measure contrast sensitivity in the initial clinical trial. The corrected data show that contrast sensitivity did improve for a more significant number of patients than originally thought, opening an opportunity for the drops to be tested in a phase 3 trial.
“This eye drop therapy has the potential to help millions of patients challenged by cataracts worldwide. However, the study was short term, not all patients showed improvement, and only early cataracts were tested,” said Randall Olson, MD, author of the analysis. There is still much to learn about the length of effect and at what stage of cataract formation we can expect any improvement.”
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