Abstract
Purpose: :
To compare clinical performance, adverse events, physiological and subjective responses in lens care products used with various silicone hydrogel contact lenses.
Methods: :
Participants [Px] used PQT (Polyquad/Tearglyde; Alcon), 3% H2O2 or PHMB (CIBA) with either galyfilcon A, senofilcon A, lotrafilcon B, lotrafilcon A, balafilcon A or comfilcon A over three months daily wear and overnight disinfection. Results of two separate analyses compare 236 Px using PQT to 292 Px using H2O2 and to 237 Px using PHMB.Clinical and subjective variables were collected and analysed using a linear mixed model at scheduled baseline, two week, one month and three month visits. Adverse event data was collected and analysed using a logistic regression model for both scheduled and unscheduled visits. Results are presented as percentage of Px and repeated observations within the same Px who participated in more than one trial, were controlled for in the statistical model.
Results: :
PQT had significantly higher first-event incidence of significant corneal inflammatory events [CIE] compared to H2O2 (10.2% vs 0.7% p<0.01) and PHMB (10.2% vs 4.6% p=0.016) as well as a higher rate of solution induced corneal staining compared to H2O2 (16.5% vs. 1.7% p<0.01). No significant difference was observed between PQT and other solutions for mechanical adverse events (p>0.05).Significantly more Px agreed lenses were easier to handle when using H2O2 and PHMB compared to PQT (H2O2 : 94.7% vs. 84.2% p<0.01, PHMB: 93.4% vs 84.2% p=0.001). In addition, more Px using PHMB agreed lenses were comfortable on insertion (91.3% vs 85.5% p=0.049) and during the day (93.9% vs 86.8% p=0.01) compared to PQT.The above differences between the two solutions did not significantly interact with the lens types (p>0.05).
Conclusions: :
The PQT solution had significantly more CIE and less favourable subjective responses when compared to either H2O2 or PHMB solution.
Clinical Trial: :
www.anzctr.org.au ACTRN 12608000329369
Keywords: contact lens • clinical (human) or epidemiologic studies: prevalence/incidence • inflammation