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C. Lakkis, K. Weidemann; Clinical Evaluation of a New Non–Surface Treated Silicone Hydrogel Lens During Continuous Wear . Invest. Ophthalmol. Vis. Sci. 2006;47(13):2395.
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To investigate the clinical and subjective performance of comfilcon A (CooperVision, Inc), a new silicone hydrogel contact lens (CL) without surface treatment or incorporated wetting agents, during 30 day continuous wear (CW) over 9 months (M).
A prospective, randomised, double masked, contralateral study was conducted; n=60 experienced soft CL wearers were assigned to wear a comfilcon A (Dk=128, water content (WC)=48%, modulus (Mod)=0.75) lens in one eye and either lotrafilcon A (Dk=140, WC=24%, Mod=1.4, CIBA Vision) or balafilcon A (Dk=99, WC=36%, Mod=1.1, Bausch & Lomb) in the other eye (n=30 per group). Subjects were evaluated at CL delivery and after 1 week (W), 1, 2, 3, 6 and 9 M of CW. Assessment of high and low contrast visual acuity (VA), the anterior eye, CL fitting and CL surface characteristics, and subjective evaluation of the CLs was conducted at each visit.
N=44 (73%) successfully completed 9 M of CW. Significant but non–serious adverse responses, such as superior epithelial arcuate lesions (SEALs), contact lens related papillary conjunctivitis (CLPC) and infiltrates, were observed in n=8 (13%) comfilcon A, n=5 (17%) lotrafilcon A and n=16 (53%) balafilcon A wearing eyes. The incidence of infiltrative events, contact lens acute red eye (CLARE) and SEALs were all significantly higher in eyes wearing balafilcon A compared to comfilcon A (p<0.05). Conjunctival epithelial flaps (lens edge) were observed in n=24 eyes (27%) at 9 M; flaps were noted in the superior and inferior quadrants only.
When compared to lotrafilcon A and balafilcon A, the new lower modulus, non–surface treated comfilcon A did not vary significantly in the majority of objective and subjective measures of performance over 9 M of CW. The incidence of adverse responses with comfilcon A was significantly lower than with balafilcon A.
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