Prospective study of lotrafilcon B lenses comparing 2 versus 4 weeks of wear for objective and subjective measures of health, comfort, and vision

摘要

OBJECTIVE:: To examine potential changes in comfort, ocular health, and vision between 2 weeks and 1 month for wearers of lotrafilcon B lenses. METHODS:: Up to 120 current wearers of lotrafilcon B lenses were recruited to wear a new pair of lenses for 1 month, using their habitual lens care system. Subjective ratings, biomicroscopy scores, visual acuity, and lens assessments were recorded at 2 weeks and at 1 month. In addition, participants responded to 4 Likert-type statements regarding comfort and vision after the full month of wear. RESULTS:: No significant differences were noted in biomicroscopy scores between 2 weeks and 1 month. Noninferiority from 2 weeks to 1 month was established for subjective ratings of visual clarity (P=0.003; n=112) and ocular redness (P<0.001; n=112); the other 7 subjective ratings (for comfort, dryness, etc.) decreased less than 1 unit on 10-point scales. Significant majorities of respondents (all P<0.001 vs. 50%) agreed or strongly agreed that the lenses provided excellent comfort (83.5% of respondents) and clear vision (83.5%) throughout the month and that comfort (71.5%) and vision (77.9%) were the same at the end of the month as at the beginning of the month. Two adverse events occurred during the trial. Both were asymptomatic and considered clinically insignificant. CONCLUSIONS:: Significant majorities of patients agreed that the lenses provided consistent comfort and vision throughout the month. Most wearers of lotrafilcon B lenses did not perceive substantial deteriorations in comfort or vision over the recommended wearing interval. Outcomes support monthly replacement of these lenses.