Ocular tolerance of a new multipurpose solution specifically formulated for daily wear of silicone hydrogel contact lenses.
OBJECTIVE
To evaluate the safety, physiological performance, and effect on ocular tissues of a new multipurpose disinfecting solution (MPDS) specifically formulated for use with silicone hydrogel (SH) contact lenses (CL).


METHODS
Two MPDS [solution A (Solo-care Aqua(®), Ciba-Vision) and solution B (Hidro Health(®), Disop)] were randomly assigned and prescribed in a clinical trial in a crossover clinical trial (Registered #293/07/EC; Spanish National Health Department). Only lotrafilcon B CL daily wearers were included. After each solution was used, a masked investigator assessed the slit-lamp findings (SL9, Topcon Inc.), lens deposits, and wettability according to the Guidance for clinical investigation (ISO 11980). CL daily wearing time (hours per day and days per week) were recorded.


RESULTS
Fifty-four daily wearers were included. Average CL wear time was 8.3 ± 2.3 (CI95% 7.9-8.7) hours per day (8.5 ± 2.7 at baseline visit, 8.2 ± 1.9 with solution A, and 8.4 ± 2.2 with solution B). The average number of days per week of CL wear was 5.9 ± 1.3 (CI95% 5.6-6.1) (5.4 ± 1.6 at baseline visit, 6.1 ± 0.9 with solution A, and 6.0 ± 1.1 with solution B). Non-adverse slit-lamp findings were recorded (higher than 2 points). No statistical difference (P>0.05 Friedman test) in CL wearing time, number of days of CL wears and slit-lamp findings were found between the two solutions.


CONCLUSIONS
This clinical trial shows that the new formulation of Hidro Health(®) MPDS is safe when used for the care of daily-wear lotrafilcon B CL. This new solution has no clinical significance on ocular tissues, according to the Guidance for clinical investigation (ISO 11980).
Martin
Raul
R
IOBA-Eye Institute and Department of Physics TAO - School of Optometry, University of Valladolid, Valladolid, Spain. raul@ioba.med.uva.es
Rodriguez
Guadalupe
G
de Juan
Victoria
V
Fernandez
Itziar
I
Sanchez
Irene
I
de la Rosa
Cristina
C
de Paz
Isabel
I
Zalama
Maria
M
D000293:Adolescent; D000328:Adult; D001251:Astigmatism / Q000628:therapy*; D018639:Contact Lens Solutions / Q000009:adverse effects*; D003263:Contact Lenses, Hydrophilic; D018592:Cross-Over Studies; D004339:Drug Compounding; D009877:Endophthalmitis / Q000139:chemically induced* / Q000175:diagnosis*; D005260:Female; D006801:Humans; D020100:Hydrogels; D008297:Male; D012828:Silicones; D016896:Treatment Outcome; D055815:Young Adult
D018639:Contact Lens Solutions; D020100:Hydrogels; D012828:Silicones