Bausch notes Xiidra study shows eased lens discomfort

Executive Summary

• Bausch + Lomb announced the publication of data from a prospective, investigator-initiated study evaluating the efficacy of Xiidra (lifitegrast ophthalmic solution) 5% in alleviating end-of-day (EOD) eye dryness and discomfort in symptomatic contact lens wearers.
• The study, published in Clinical Ophthalmology, demonstrated that Xiidra significantly improved EOD dryness and discomfort over a 12-week period, reinforcing results from four previous clinical studies.
• Key findings include a median improvement of 61 and 59 points on a 100-point visual analog scale for EOD dryness and discomfort, respectively, after 12 weeks of use, with significant improvements observed as early as two weeks.

Key Details

• Study Design: Investigator-initiated, prospective, open-label study involving 40 participants who were symptomatic soft contact lens (CL) wearers.
• Treatment Protocol: Participants used Xiidra twice daily for 12 weeks while continuing to wear their usual contact lenses.
• Primary Endpoints: The study met its primary endpoints, showing significant improvement in CL wear-related EOD eye dryness and discomfort over time (P < 0.01).
• Visual Analog Scale (VAS) Results:
  • Median VAS scores improved by 61 points for EOD dryness and 59 points for EOD discomfort on a 100-point scale (where 100 is worst) after 12 weeks.
  • Significant reductions in EOD dryness and discomfort were observed at both two and six weeks compared to baseline.
• CLDEQ-8 Scores:
  • Statistically significant reduction in Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) scores at two, six, and 12 weeks.
  • A six-point reduction in CLDEQ-8 scores was observed for symptomatic wearers of 17 different contact lens types after just two weeks.
  • After 12 weeks, 90% of participants achieved a clinically meaningful improvement of at least three points in CLDEQ-8 scores.
  • 45% of participants (18/40) improved to such a degree after two weeks that they would no longer have met the symptom-related eligibility criteria for the study.
• Symptom-Specific Improvements: Significant improvement in burning/stinging, itching, foreign body sensation, photophobia, and pain was seen as early as two weeks.
• Wear Time: Mean comfortable CL wear time increased from 6.5 hours at baseline to 9.1 hours at 12 weeks. Total wear time remained unchanged.
• Safety Profile: Xiidra was well-tolerated with only two reports of treatment-related adverse events. Study findings indicated it could be safely used by CL wearers.
• Study Limitations: Single-centre, open-label design with no control group. Participants had used artificial tears or rewetting drops ≥1 time per month prior to the study, which may have influenced results. No formal conclusions should be drawn due to design limitations.

Notable Quotes

• Andrew Stewart, President, Global Pharmaceuticals and International Consumer, Bausch + Lomb: "Although the use of OTC rewetting drops provides temporary relief for some wearers, their benefit is only moderate and contact lens discomfort typically worsens as the day progresses. This study showed that Xiidra may be a suitable alternative for symptomatic contact lens wearers who can't achieve comfort or relieve dryness by switching their contact lenses or using OTC drops."
• Marc-Matthias Schulze, PhD, Principal Investigator and Senior Clinical Scientist, Centre for Ocular Research & Education: "The significant improvements in symptoms of end-of-day dryness and discomfort for contact lens wearers in as little as two weeks highlighted the effectiveness of Xiidra, even after a short period of use. Additionally, results showed continued use of Xiidra throughout the study further improved symptoms, demonstrating that Xiidra remains an effective treatment over time and may allow contact lens wearers to enjoy their lenses throughout the entire day."