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OBJECTIVE: To evaluate corneal endothelial bleb response to wear of silicone-hydrogel contact lenses in eyes of East Asian subjects. METHODS: A total of 24 subjects of East Asian origin, attended 3 separate sessions for a prospective, single-centre, trial. The following contact lenses were used: ACUVUE ADVANCE with HYDRACLEAR (ADVANCE, -3 dioptres), ACUVUE OASYS with HYDRACLEAR Plus (OASYS, -3 dioptres), Focus NIGHT & DAY (NIGHT & DAY, -3 dioptres) and SofLens 38 (+3 dioptres). A modified Balaam's crossover design was used to randomize presentation of sessions and contact lenses within sessions. Session 1 was a comparison between OASYS and SofLens 38 under closed eye conditions, session 2 was a comparison between ADVANCE and NIGHT & DAY under open eye conditions, and session 3 was a comparison between OASYS and NIGHT & DAY worn under closed eye conditions. Corneal endothelial images were captured with the Topcon SP-3000P noncontact Specular Microscope before lens wear, after 20 mins of wear with lenses on and 5 and 10 mins later after lens removal. Blebs were manually identified on these digital images by a masked observer. The area of blebs and total area under consideration were derived using ImageNet software and used to calculate percentage area of blebs. A boundary of equivalence of 1% was used as a clinically significant bleb area difference, and two-sided 95% confidence intervals were utilized to evaluate differences between lenses within each session. RESULTS: In session 1, SofLens 38 produced a mean percentage area of blebs of 8.0% under closed eye conditions, which was significantly different to that produced by OASYS (1.6%). In session 2, both Advance and Night & Day produced a mean percentage bleb area of 0.4% under open eye conditions. In session 3, OASYS and NIGHT & DAY produced statistically similar mean percentage bleb areas of 1.7% and 2.0%, respectively. CONCLUSIONS: The similarity of bleb responses induced by the silicone-hydrogel lenses under the tested wearing conditions is consistent with the proposition that increases in Dk/t above a certain level will produce minimal change in corneal physiologic conditions compared with that when no lens is worn.

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PURPOSE: To evaluate the clinical performance of comfilcon A (Biofinity) during 12 months of continuous wear compared to other silicone-hydrogel lenses. METHOD: Forty-five subjects were fitted in one eye with the comfilcon A (test) lens. For 22 subjects, the other eye was fitted with lotrafilcon A (group A) and for the remaining 23 subjects the other eye was fitted with balafilcon A (group B). Twelve-month data are presented on 48 measured variables. RESULTS: There were no serious adverse events during the course of the study. A total of 33 subjects completed the study, with only 4 discontinuations for lens-related reasons, spread proportionately between the lenses. On preference scales, the test lens was superior to both control lenses for comfort (p<0.05) and overall preference (p<0.05) and in group A for vision (p<0.05). On grading scales, the test lens scored better than both control lenses for overall comfort (p<0.1 for group A, p<0.05 for group B), comfort during the day (p<0.05), end-of-day comfort (p<0.05) and overall preference (p<0.05), and better in group A for general vision quality (p<0.01), night vision quality (p<0.01) and handling (p<0.05). All lenses performed to a comparable degree on the basis of microcysts and corneal staining. There were significant differences between lenses in producing limbal redness (p<0.05), bulbar conjunctival hyperemia (p<0.1) and conjunctival NaFl staining (p<0.01) with the control lens in group A showing the greatest effect and the control lens in group B the least. CONCLUSION: Comfilcon A offers performance advantages over first generation silicone-hydrogel materials for continuous wear.

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PURPOSE: To examine the clinical performance of two brands of silicone-hydrogel lenses when worn on a daily wear basis. METHODS: Fifty-six subjects with no ocular disease were enrolled at multiple sites in Australasia. Contact lenses made from galyfilcon A or lotrafilcon A were randomly assigned to each eye of the subject and the lenses were worn on a daily wear basis for a period of two weeks. Subjects did not know the identity of the lenses they wore. Clinical data and patient responses to a questionnaire were gathered at an initial visit and after two weeks of wear. RESULTS: For both lenses, the degree of limbal hyperaemia and bulbar conjunctival hyperaemia decreased significantly over the two-week wearing period. The eyes wearing galyfilcon A lenses showed an increase in conjunctival staining compared to the baseline measures. On average, galyfilcon A lenses decentred more and moved less than the lotrafilcon A lenses. The lotrafilcon A lenses showed a greater loss of wettability, as judged by practitioner grading, than the galyfilcon A lenses over the two-week period. The subjective responses showed strong preference for the galyfilcon A lens across 26 of 27 questions relating to comfort, vision, handling, preference and other subjective outcomes. DISCUSSION: The results show that different silicone-hydrogel lenses have different performance characteristics on the eye, when worn on a daily wear basis. Striving for high oxygen transmissibility at the expense of other properties may lead to a range of undesirable performance characteristics.

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BACKGROUND: Daily disposable contact lenses are considered to be the pinnacle of safe contact lens wear, yet it has been suggested that it takes some period of wear for the lens surface to reach optimal compatibility with the ocular surface. This study assesses the influence of brief treatment with a conditioning drop on the ocular response to new contact lenses over a single day of wear. METHODS: The study was a single-masked, paired (contralateral) comparison of the signs and symptoms with wear of new Acuvue 2 contact lenses pretreated with a conditioning agent containing carboxymethylcellulose (carmellose, CMC) against new lenses inserted directly from the blister pack. Sixty-one subjects participated in the study, of whom 59 were considered eligible for data analysis. Subjects were also divided into symptomatic and asymptomatic lens wearers based on their overall comfort level in lens wear. Symptoms and signs were recorded at lens delivery and following eight hours of wear. RESULTS: A set of slitlamp signs, comprising corneal staining (p <0.05), limbal redness (p <0.05), bulbar conjunctival hyperaemia (p <0.05), bulbar conjunctival staining (p <0.01) and palpebral conjunctival redness (p <0.05) showed small but statistically significant (p <0.05) end-of-day mean values in favour of the lens that was conditioned with the rewetting agent. These data were supported by the proportion of subjects showing lower gradings with conditioned lenses versus unconditioned lenses, as follows: corneal staining (35 per cent versus 12 per cent, p <0.05), limbal redness (43 per cent versus 22 per cent, p <0.05), bulbar conjunctival hyperaemia (50 per cent versus 15 per cent, p <0.05), bulbar conjunctival staining (46 per cent versus 30 per cent, p <0.1) and palpebral conjunctival hyperaemia (28 per cent versus 17 per cent, NS). For those subjects reporting symptoms with lens wear (n=12), there was a statistically significant (p <0.05) preference in terms of comfort as a result of preconditioning. CONCLUSIONS: The results of the investigation suggest that use of a conditioning agent can provide a more physiologically suitable environment for a new lens, thereby reducing the clinical signs associated with lens discomfort. The protocol used here, which is based on a statistical paradigm using standard pictorial grading scales, allows high sensitivity in detecting small changes in ocular parameters.

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PURPOSE: To evaluate silicone-hydrogel balafilcon A (PureVision, Bausch & Lomb Inc., Rochester, NY) contact lenses worn on a 30-day continuous wear basis when compared with a traditional hydrogel (Acuvue, Vistakon, Johnson and Johnson Vision Products, Inc., Jacksonville, FL) worn on a 7-day extended wear schedule. DESIGN: Prospective, comparative, paired-eye, interventional, multicenter clinical trial. PARTICIPANTS: Two hundred twelve ametropes with no significant ocular pathology. METHODS: Subjects with normal ocular health who conformed to a set of standard criteria were monitored at seven different sites around the globe. Subjects wore both study lenses simultaneously, one on each eye. Lenses were assigned to right and left eyes according to a randomized schedule. The silicone hydrogel was removed and replaced every month and the traditional hydrogel was removed every 7 days and replaced at 14-day intervals. Subjects were followed for up to 1 year with discontinuation on indication divided between lens-related causes, unrelated factors, and loss to follow-up. MAIN OUTCOME MEASURES: Discontinuations, symptoms, vision, lens fit, lens surface assessment, slit-lamp assessment, and patient preferences. RESULTS: One hundred twenty three subjects completed the 12-month wearing period. There were no vision-threatening events with either lens type. The silicone-hydrogel lenses showed statistically superior performance in physiologic terms with regard to epithelial microcysts, striae, corneal staining, limbal injection, and bulbar injection. Inflammatory reactions, such as corneal infiltrates and tarsal conjunctival abnormalities occurred at similar rates between the lens types. Visible deposition and postlens debris with associated transient corneal indentation were significantly lower with the traditional hydrogel material at specific time points in the study. Visual acuity was comparable with the two lens types. Subjects rated the silicone-hydrogel material as preferable on subjective scales of dryness, comfort, and lens handling. Overall subjective performance was rated superior with the silicone-hydrogel material. CONCLUSIONS: The high oxygen performance of the silicone-hydrogel lenses provides a superior physiologic environment compared with a traditional hydrogel material during continuous wear. Despite the slightly higher levels of visible deposit on the silicone-hydrogels, superior subjective responses suggest that the plasma coating technology on these lenses is effective in providing comfortable lens wear. The results look promising for the success of silicone-hydrogels as the material of choice for continuous wear contact lenses.

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