Use of silicone hydrogel material for daily wear.

Silicone hydrogel contact lenses were initially developed to optimise oxygen transmissibility for extended wear use. The concerns with such contact lenses have been their higher elastomeric and hydrophobic characteristics associated with the incorporation of silicone type monomers. The use of silicone hydrogel has most recently been suggested for daily wear to eliminate all hypoxic related problems. The primary aim of the investigation was to test in vivo wetting performance and subjective acceptance of the first silicone hydrogel contact lens developed for daily wear, ACUVUE ADVANCE with HYDRACLEAR (galyfilcon A), compared to a conventional hydrogel contact lens for the same application SofLens 66 (alphafilcon A). The investigation was a randomised, subject masked bilateral cross over investigation testing of the two contact lens materials over their approved replacement periods (galyfilcon A 2 weeks and alphafilcon A 2 weeks (USA) and 4 weeks (Europe)). In all cases ReNu Multiplus lens care system was used. The investigation carried out on 24 contact lens wearers showed that: (i) in vivo wettability was superior for galyfilcon A which had a thicker lipid layer (thin layer incidence: galyfilcon A 54%; alphafilcon A 70-86%, p<0.05), a thicker aqueous layer (thick layer incidence: galyfilcon A 88%; alphafilcon A 35-64%, p<0.05) and a more stable tear film (galyfilcon A 7.8s; alphafilcon A 2 weeks 5.6s, p=0.022; 4 weeks 7.4s, p=0.276); (ii) for the intended replacement period, comfort was better with galyfilcon A (2 weeks) compared to alphafilcon A (4 weeks) at insertion (p=0.001) and, throughout the day (daytime and evening p=0.008). Contact lenses made from galyfilcon A and replaced two weekly achieved better in vivo wettability than contact lenses made from alphafilcon A and replaced either two and four weekly; the better wettability was associated with an overall better comfort for galyfilcon A.

RCT Entities:   Population Interventions Outcomes