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

Ciba Vision

Status: Completed

Conditions: Myopia

Treatments: Device: Senofilcon A; Device: Lotrafilcon B

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01433549

P-373-C-104

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 44 patients

Sex: All

Ages: 17+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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44 participants in 2 patient groups

Lotrafilcon B / Senofilcon A

Other group

Description:

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).

Treatment:

Device: Lotrafilcon B

Device: Senofilcon A

Senofilcon A / Lotrafilcon B

Other group

Description:

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).

Treatment:

Device: Lotrafilcon B

Device: Senofilcon A