| Popis: |
AIM: To evaluate and compare the clinical performance of 5 kinds of polyhexamethylene biguanide (PHMB) based multi-purpose solutions (MPS) manufactured in China when used with a commercially available silicone hydrogel contact lens in terms of solution-induced corneal staining (SICS), ocular response (corneal staining and ocular hyperemia), corneal infiltrative event (CIEs) and ocular comfort. METHODS: This was a prospective, open label, randomized, parallel group clinical trial. Totally 162 participants (Pxs) who were at least 18y were enrolled and randomized into 5 groups of PHMB-based MPS made in China: Complete® MPS, Hydron® Aqua-shining moist, Baoshining™, Weicon® Fresh, Weicon® 2000 MPS (abbreviated as C, H, B, W, and W2). All participants wore balafilcon A contact lenses with monthly disposal (Bausch & Lomb Purevision®) in conjunction with the designated MPS on a daily wear for 3mo. Clinical visits were at baseline, 2wk, 1mo and 3mo. SICS and CIE were reported as first event incidence per 100 Px-months. Ocular response was graded on 0-4 scale in 0.5 steps (0=none, 4=severe) and ocular comfort was assessed via a numeric rating scale (1-10 in 1-point steps, 1=poor, 10=excellent). Ocular comfort and ocular response variables were analysed using linear mixed model. CIE and SICS were analysed using Fisher’s exact test and logistic regression. RESULTS: There were 36 (22%) Pxs who dropped out. SICS incidence for each MPS were: H (26.3%), B (20.8%), W (19.4%), W2 (13.4%), C (12.8%). The SICS rate of H was significantly different to W2 (P=0.012) and C (P=0.005). There were no significant differences in ocular response, CIE incidence and ocular comfort between different MPSs (P>0.05). Pxs with SICS had significantly lower comfort during the day and at the end of than those who did not have SICS. CONCLUSION: Differences in SICS incidence are found between MPSs but not for CIE incidence, ocular response or ocular comfort. SICS in PHMB-based MPS is found to be associated with ocular discomfort. More MPS/lens combinations should be studied in the future. |
