Bausch + Lomb publishes results from Xiidra 5% study

Bausch + Lomb (BLCO) announced Clinical Ophthalmology has published results from an investigator-initiated study which evaluated the effectiveness of Xiidra 5% in alleviating end-of-day eye dryness and discomfort in symptomatic contact lens wearers. Xiidra is a prescription eye drop used to treat the signs and symptoms of dry eye disease by targeting a source of inflammation. These results reinforce the results from four previous clinical studies which demonstrated that Xiidra significantly reduced symptoms of eye dryness over 12 weeks. The investigator-initiated, prospective, open-label study evaluated whether comfort and dryness in symptomatic soft CL wearers improved after using Xiidra twice a day for 12 weeks while continuing to wear their usual contact lenses. In total, 40 participants completed the study, which assessed the performance of Xiidra by comparing ratings on a visual analog scale at two, six and 12 weeks for EOD dryness and discomfort and Contact Lens Dry Eye Questionnaire-8 scores to baseline levels. The study met its primary endpoints and showed that there was a significant improvement in CL wear-related EOD eye dryness and discomfort over time. Median VAS scores improved by 61 and 59 points on a 100-point scale for EOD dryness and discomfort, respectively, after 12 weeks of Xiidra use. Xiidra use also resulted in a significant reduction in CL wear-related EOD eye dryness and discomfort after two and six weeks compared to baseline. EOD dryness symptoms improved in about half of the 40 study participants to such a degree that they would not have met the symptom-related eligibility criteria for this study after just two weeks of treatment. Xiidra use resulted in statistically significantly reduced CLDEQ-8 scores in comparison to baseline at the 2-week, 6-week and 12-week follow-up visit. There was a 6-point reduction in CLDEQ-8 scores for the symptomatic wearers of 17 different contact lens types after just two weeks, with CLDEQ-8 scores continuing to decrease over the 12-week study period. After 12 weeks, 90% of participants achieved a clinically meaningful improvement of at least three points in CLDEQ-8 scores compared to baseline. Significant improvement in ratings for each of the five VAS symptoms of burning/stinging, itching, foreign body sensation, photophobia and pain was seen as early as two weeks of Xiidra use and continued throughout the study period. Xiidra use showed an increase in mean comfortable CL wear time. There were no changes in total wear time during the study. Study findings indicated that Xiidra could be safely used by CL wearers. Xiidra was well tolerated with two reports of treatment-related adverse events.