K 84To determine the ocular tolerability and safety of two new tear film substitutes
J. Theophylaktopoulos1, S. Dinslage1, M. Diestelhorst1, W. Stoffel2
Purpose: To determine the tolerability, safety and visual comfort of two new tear film substitutes in a phase I clinical study.
Methods: In a randomized double-masked cross-over study two preservative free phosphatidylcholine solutions were studied in 20 eyes of 20 healthy volunteers (26 32 years of age). According to randomisation one eye of each volunteer was treated 4 times a daily for 7 days with solution I or solution II. The contralateral eye served as control. After a washout of 7 days the same eye was treated 4 times daily with the second medication according to randomisation. Before, +1 week, +2 weeks and +3 weeks slitlamp biomicroscopy, visual acuity, visual analog scales and side effects were studied.
Results: No eye showed allergic reactions or any other side effects like hyperemia, corneal disturbance and foreign body deposites. Both substances were well tolerated and had no influence on the visual acuity.
Discussion: Both preservative free phosphatidylcholine solutions showed good tolerability and safety in human eyes. In the future the effect and safety of both medications shall be investigated in patients with keratoconjunctivitis sicca and dry eye syndrome.
1Dept. of Ophthalmology, University of Cologne, Germany