Ex vivo analysis of ketotifen content in an antihistamine-eluting contact lens worn up to 5 hours.

Brian Pall, Shivkumar Mahadevan, Azaam Alli, Frank Yi, Paul Gomes

Therapeutic delivery 2023 Jul

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Aim: This study characterized ex vivo release of ketotifen from etafilcon A contact lenses worn over 5 h. Materials & methods: 14 participants, 21 to 59 years, wore lenses with 19 μg ketotifen over 8 visits, for 1 min to 5 h. Residual ketotifen was measured using high-performance liquid chromatography (HPLC) compared with unworn lenses from the same lots to determine percent ketotifen remaining. Results: Residual ketotifen ranged from 16.19 μg ± 0.44 (84.1%) [1 minute] to 0.20 μg ± 0.07 (1.1%) [5 h]. No adverse events or clinically significant biomicroscopy changes were observed. Conclusion: The ketotifen-releasing etafilcon A lenses were well-tolerated with an acceptable safety profile in the population studied. The release of ketotifen from study lenses over 5 h was consistent with a diffusion-controlled system.

Citation

Brian Pall, Shivkumar Mahadevan, Azaam Alli, Frank Yi, Paul Gomes. Ex vivo analysis of ketotifen content in an antihistamine-eluting contact lens worn up to 5 hours. Therapeutic delivery. 2023 Jul;14(7):407-417