Recent research published in Clinical Ophthalmology offers supporting results from a phase 4 investigator-initiated study on the effectiveness of Bausch + Lomb Corporation’s XIIDRA (lifitegrast ophthalmic solution) 5% among one specific patient demographic: contact lens (CL) wearers.
Let’s start with XIIDRA.
Approved by the FDA in 2016, this non-steroid eye drop is indicated to treat the signs and symptoms of dry eye disease (DED).
- Its recommended dosage: One drop administered twice daily (BID) in each eye, approximately 12 hours apart.
Notably: The product’s prescribing information (PI) advises that CL wearers remove their lenses prior to using XIIDRA—and wait 15 minutes before placing them back in.
And this wasn’t originally owned by B+L, right?
Correct. The company purchased XIIDRA in 2023 (check out our coverage) from Novartis.
See here for B+L’s extensive history of acquisitions (five different companies in total).
Noted. Now, why the need for further investigation?
XIIDRA’s FDA approval was based on results from four randomized clinical trials evaluating its use versus a placebo among over 1,000 patients with the symptoms and signs of dry eye.
Comparatively: This latest research analyzed whether eye dryness and discomfort among soft CL wearers (of varying lens types, unlike prior evaluations) improved following use of the prescription-based eye drop for 12 weeks.
Give me some details on this.
The prospective, open-label study (NCT04297618) was conducted in collaboration with Novartis at the University of Waterloo in Ontario, Canada. The basics of its design included:
- Participants: 45 patients (aged 18+; 84% females) with symptomatic eye dryness and currently wearing soft CLs in both eyes (see full criteria)
- Setup: All patients topically applied XIIDRA eye drops as prescribed (BID)
- Duration: 12 weeks
And what was measured?
Measured at baseline and week 12, the primary endpoints were:
- Difference in contact lens-related discomfort
- Difference in contact lens-related dryness
To note:
- Both were rated by patients on a visual analogue scale (VAS) of 0 (no discomfort) to 100 (maximum discomfort)
- See here for additional endpoints
- VAS rates were assessed at 2, 6, and 12 weeks for end-of-day (EOD) dryness and discomfort, as were Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) scores to baseline levels
Now to the findings.
Of those initial 45 patients, 40 (ages 18 to 66) completed the study and wore their CLs between five and seven days per week.
- Participants wore 17 different CL types, with 26 daily disposables and 14 reusable wearers (lens designs were not factored in)
And one note regarding those ages: The mean age (30.8 years) in this study was significantly lower than that in prior phase 3 studies evaluating XIIDRA.
- The investigators’ thoughts on this: The younger age of CL wearers “emphasizes the need for clinicians to continuously monitor and address patient-reported symptoms of discomfort and dryness,” they stated.
Talk endpoints.
The study met both its primary endpoints, with significant improvement in CL wear-related EOD eye dryness and discomfort over time.
- On the 100-point scale: After 12 weeks of XIIDRA use, the median VAS scores improved by 61 and 59 points for EOD dryness and discomfort, respectively
- After 2 and 6 weeks (versus baseline): XIIDRA use led to a significant reduction in CL wear-related EOD dryness and discomfort
Interestingly: 45% of patients saw their EOD dryness symptoms improve “to such a degree that they would not have met the symptom-related eligibility criteria” for the study after just 2 weeks of XIIDRA use.
And how did CLDEQ-8 scores compare by week 12?
At each of the three follow-up visits (2, 6, and 12 weeks), XIIDRA use led to “statistically significantly reduced CLDEQ-8 scores” versus baseline.
- By week 2, a 6-point CLDEQ-8 score reduction was observed, and it continued to decrease over the remainder of the study
- By week 12, 90% of patients had achieved a "clinically meaningful improvement” of at least 3 points in CLDEQ-8 scores
Now to symptom relief and CL wear time.
Patients’ ratings for five VAS symptoms—burning/stinging, itching, foreign body sensation, photophobia, and pain—significantly improved throughout the study, starting as early as 2 weeks of XIIDRA use.
As for CL wear time: While patients didn’t wear their lenses for longer durations each day, they did report experiencing “significantly longer comfortable wear times” throughout the study’s duration.
- Mean total and comfortable CL wear times were:
- 11.3 and 6 hours, respectively, at baseline and the dispense visit:
- 11.5 and 9 hours, respectively, by the 12-week follow-up visit
Aside from those EOD symptoms, were any other improvements noted?
No changes were observed for the following clinical signs: tear film stability or inflammatory markers; ocular redness, staining, or palpebral redness and roughness.
- What this indicates: XIIDRA does not impact ocular surface integrity during CL wear.
As for adverse effects: A total of 14 were observed. While no serious adverse events (AEs) were identified, two AEs were linked to XIIDRA use (resulting in one withdrawal) and eight were ocular AEs.
- See here for notable limitations to the study’s setup and design (including no control treatment arm)
And looking to future studies?
The study authors reasoned that future evaluations could determine if other clinical signs (corneal staining or tear osmolarity) may improve after prolonged use of XIIDRA among CL wearers.
So, what’s the takeaway from this?
Essentially: XIIDRA can be considered an effective (and safe) treatment for symptomatic CL wearers.
- But more specifically: The authors wrote that “(XIIDRA) may be a suitable alternative for symptomatic CL wearers who cannot achieve satisfactory comfort and dryness with alternate CLs or over-the-counter comfort enhancing drops.”