Lens Wear Schedules and End-of-Day Comfort (INVERMERE)

• Eye Comfort [ Time Frame: After 12 hours (six 2-hour intervals of wear) ] [ Designated as safety issue: No ]
  As assessed by the participant on a questionnaire. For each eye, the participant will draw a mark on a scale that best represents eye comfort.
• Eye Comfort [ Time Frame: After 12 hours (five 2-hour intervals of wear, each separated by 30 minutes of non-wear) ] [ Designated as safety issue: No ]
  As assessed by the participant on a questionnaire. For each eye, the participant will draw a mark on a scale that best represents eye comfort.
• Eye Comfort [ Time Frame: After 12 hours (four 2-hour intervals of wear, each separated by 60 minutes of non-wear) ] [ Designated as safety issue: No ]
  As assessed by the participant on a questionnaire. For each eye, the participant will draw a mark on a scale that best represents eye comfort.
• Eye Comfort [ Time Frame: After 12 hours (four 2-hour intervals of wear, each separated by 80 minutes of non-wear) ] [ Designated as safety issue: No ]
  As assessed by the participant on a questionnaire. For each eye, the participant will draw a mark on a scale that best represents eye comfort.

• Non-Invasive Tear Film Break-Up Time [ Time Frame: After 12 hours (six 2-hour intervals of wear) ] [ Designated as safety issue: No ]
  As assessed by the investigator using a corneal topographer. The participant will blink, then keep eyes open while the investigator records the time in seconds for the mires on the topographer image to appear blurry. Three readings per eye will be taken.
• Non-Invasive Tear Film Break-Up Time [ Time Frame: After 12 hours (five 2-hour intervals of wear, each separated by 30 minutes of non-wear) ] [ Designated as safety issue: No ]
  As assessed by the investigator using a corneal topographer. The participant will blink, then keep eyes open while the investigator records the time in seconds for the mires on the topographer image to appear blurry. Three readings per eye will be taken.
• Non-Invasive Tear Film Break-Up Time [ Time Frame: After 12 hours (four 2-hour intervals of wear, each separated by 60 minutes of non-wear) ] [ Designated as safety issue: No ]
  As assessed by the investigator using a corneal topographer. The participant will blink, then keep eyes open while the investigator records the time in seconds for the mires on the topographer image to appear blurry. Three readings per eye will be taken.
• Non-Invasive Tear Film Break-Up Time [ Time Frame: After 12 hours (four 2-hour intervals of wear, each separated by 80 minutes of non-wear) ] [ Designated as safety issue: No ]
  As assessed by the investigator using a corneal topographer. The participant will blink, then keep eyes open while the investigator records the time in seconds for the mires on the topographer image to appear blurry. Three readings per eye will be taken.

The purpose of this study was to assess the impact of lens-free (recovery) intervals of varying lengths on end-of-day comfort and tear film changes with daily contact lens wear.

This study was conducted in a cross-over design with two phases. Each phase consisted of four cycles approximately 12 hours in length. During each cycle, contact lenses were worn for 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes. A new pair of contact lenses was dispensed for each 2-hour interval of lens wear. A 12-hour lens-free wear period preceded each phase.

• Device: Lotrafilcon B
  Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily wear and extended (overnight) wear up to 6 nights.
  Other Name: AIR OPTIX® AQUA
• Device: Senofilcon A
  Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily wear and extended (overnight) wear up to 6 nights.
  Other Name: ACUVUE® OASYS®

• Lotrafilcon B / Senofilcon A
  Lotrafilcon B worn first, with senofilcon A worn second, as randomized. Each product was worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
  Interventions:

  • Device: Lotrafilcon B
  • Device: Senofilcon A
• Senofilcon A / Lotrafilcon B
  Senofilcon A worn first, with lotrafilcon B worn second, as randomized. Each product was worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
  Interventions:

  • Device: Lotrafilcon B
  • Device: Senofilcon A

Inclusion Criteria:

• Is at least 17 years of age and has full legal capacity to volunteer.
• Is willing and able to follow instructions and maintain the appointment schedule.
• Has had an ocular examination in the last two years.
• Is an adapted soft contact lens wearer.
• Experiences a decrease in ocular comfort through a lens-wearing day.
• Has a current pair of spectacles.
• Has a distance contact lens prescription of +6.00 diopters to -10.00 diopters and an acceptable fit with the study lenses.
• Has astigmatism less than or equal to -1.00 DC.
• Achieves visual acuity of 6/9 or better with the study lenses and with habitual spectacles.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Has any ocular disease.
• Has a systemic condition that may affect a study outcome variable.
• Is using any systemic or topical medications that may affect ocular health.
• Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.
• Other protocol-defined exclusion criteria may apply.