PURPOSE: Contact lens use can disrupt the tear film and increase eye dryness. Perfluorohexyloctane ophthalmic solution (PFHO), which is indicated for the treatment of signs and symptoms of dry eye disease, was shown to be safe and efficacious in non-contact lens wearers and in a single-site study utilizing on-label dosing in habitual contact lens wearers. PFHO has not been evaluated when instilled while wearing contact lenses. This study evaluated the impact of concomitant use of PFHO during contact lens wear.

METHODS: This was a phase 4, multicenter, prospective, open-label trial. Adult habitual wearers of soft, frequent-replacement contact lenses (daily-disposable, biweekly, or monthly) instilled PFHO bilaterally 4 times daily (1 time before, 3 times while wearing lenses) for 30 days. The primary endpoint was change from baseline at Day 30 in the Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8; maximum score: 37, higher scores indicate greater contact lens– related symptoms).

RESULTS: A total of 104 patients were enrolled (79.8% female; 51.9% daily replacement contact lens type modality; mean [SD] age, 39.9 [11.3] years; age range, 18-67 years). The mean (SD) CLDEQ-8 score at baseline was 12.2 (6.6). Mean (SD) change from baseline was -2.8 (4.9) at Day 7, -3.8 (4.7) at Day 14, and -4.3 (5.8) at Day 30 (P<0.001). There were no potential safety signals as all objective clinical assessment exploratory endpoints were stable throughout the study. Additional subjective parameters that were significantly improved from baseline averaged across Week 4 included mean total daily contact lens wear time, comfortable wear time, end-of- day eye dryness while wearing contact lenses, and end-of-day discomfort while wearing contact lenses (P<0.001 for all). Ocular adverse events (AEs) were reported in 10 (4.8%) of 208 eyes, and all were mild or moderate in intensity. There were no serious AEs reported. One patient (1.0%) discontinued PFHO due to AEs of eye dryness and instillation discomfort.

CONCLUSIONS: Concomitant use of PFHO with contact lens wear was well tolerated among habitual wearers of soft, frequent-replacement contact lenses with no indication of potential safety concerns. Furthermore, PFHO administration was associated with notable improvements in patient-reported assessments of contact lens performance and tolerability.