Lens Wear Schedules and End-of-Day Comfort

Myopia Clinical Trial

— INVERMERE  

Official title:

Effect of Recovery Periods on Ocular Comfort During Daily Lens Wear

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01433549
• Other study ID #: P-373-C-104
• Status: Completed
• Phase: N/A
• First received: September 12, 2011
• Last updated: April 30, 2013
• Start date: August 2011
• Est. completion date: March 2012

Study information

• Verified date: April 2013
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Myopia

Intervention

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

Locations

Country	Name	City	State
Canada	University of Waterloo Centre for Contact Lens Research	Waterloo	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
CIBA VISION	University of Waterloo

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Hour 12	No
Secondary	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.	Hour 12	No