Lens Wear Schedules and End-of-Day Comfort

CIBA VISION44 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Myopia

Interventions

Lotrafilcon BDEVICE

Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily wear and extended (overnight) wear up to 6 nights.

Senofilcon ADEVICE

Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily wear and extended (overnight) wear up to 6 nights.

Eligibility

Sex: ALLMin age: 17 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Waterloo Centre for Contact Lens Research

Waterloo, Ontario, Canada

Outcomes

Primary Outcomes

Mean End-of-Day Comfort

As assessed by the participant using a visual analog scale ranging from 0 (extremely uncomfortable) to 100 (very comfortable and fresh) at the end of each 12-hour (approximate) cycle. 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.

Time frame: Hour 12

Secondary Outcomes

Mean Non-Invasive Tear Film Break-Up Time (NITBUT)

As assessed by the investigator using a corneal topographer. NITBUT was assessed at the end of each 12-hour (approximate) cycle. 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 longer tear film break-up time indicates a more stable tear film and may lead to a more comfortable lens-wearing experience.

Time frame: Hour 12

Data from ClinicalTrials.gov

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