Ocular Comfort and the "Aging" Lens (ERBIUM)

The purpose of this trial was to evaluate the factors affecting comfortable contact lens wear and how those factors affect contact lens replacement frequency.

Study Overview

• Status: Completed
• Conditions: Refractive Error
• Intervention / Treatment: Device: Habitual contact lens; Device: Lotrafilcon B contact lens; Device: Contact lens cleaning and disinfecting system (ClearCare)

Detailed Description

Eligible participants began Phase 1, following either Cycle A or Cycle B, and crossing over to the second cycle after completing the first. After the Phase 1 results were evaluated, eligible participants entered Phase 2. After Phase 2 results were evaluated, participants who consistently reported the highest and the lowest comfort scores entered Phase 3 and were defined as either survivors or strugglers.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3G1
      • University of Waterloo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• At least 17 years of age.
• Ocular exam in the last two years.
• Currently wearing hydrogel or silicone hydrogel contact lenses on a daily wear basis with a monthly replacement schedule.
• Wearing contact lenses at least five days per week for a minimum of 10 hours each day.
• Able to wear lenses in the available power range with a best-corrected visual acuity of at least 20/32 in both eyes.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Any ocular disease.
• Systemic condition that may affect a study outcome.
• Using any systemic or topical medications that may affect ocular health.
• Wears lenses on an extended or continuous wear schedule.
• Habitually wears multifocal lenses.
• Other protocol-defined exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Phase 1: Habitual no Replacement, then Habitual Replacement; Contact lenses per participant's habitual prescription worn for 30 days with no replacement, followed by contact lenses per habitual prescription worn for 30 days with a replacement pair dispensed at Day 28.	Device: Habitual contact lens; Hydrogel or silicone hydrogel contact lens per participant's habitual brand and prescription
Other: Phase 1: Habitual Replacement, then Habitual no Replacement; Contact lenses per participant's habitual prescription worn for 30 days with replacement pair dispensed at Day 28, followed by contact lenses per habitual prescription worn for 30 days with no replacement.	Device: Habitual contact lens; Hydrogel or silicone hydrogel contact lens per participant's habitual brand and prescription
Other: Phase 2: Lotrafilcon B Replacement; Contact lenses worn for 56 days with replacement pair dispensed at Day 28.	Device: Lotrafilcon B contact lens; Commercially marketed silicone hydrogel contact lens; Other Names: AIR OPTIX AQUA; Device: Contact lens cleaning and disinfecting system (ClearCare); Commercially marketed, hydrogen peroxide-based contact lens care system; Other Names: CLEARCARE
Other: Phase 3: Lotrafilcon B Replacement Replacement; Contact lenses worn for 43 days with replacement pair dispensed at Day 1 and Day 28.	Device: Lotrafilcon B contact lens; Commercially marketed silicone hydrogel contact lens; Other Names: AIR OPTIX AQUA; Device: Contact lens cleaning and disinfecting system (ClearCare); Commercially marketed, hydrogen peroxide-based contact lens care system; Other Names: CLEARCARE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 1	Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 1 day. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE & FRESH ("Wow! My eyes feel incredible! I love this feeling.")	Day 1
Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 10	Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 1 day. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE & FRESH ("Wow! My eyes feel incredible! I love this feeling.")	Day 1
Phase 3: Ocular Comfort, Lens Age 1 Day, End of Day	Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 1 day. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE & FRESH ("Wow! My eyes feel incredible! I love this feeling.")	Day 1
Phase 3: Ocular Comfort, Lens Age 14 Days, Hour 1	Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 14 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE & FRESH ("Wow! My eyes feel incredible! I love this feeling.")	Day 15
Phase 3: Ocular Comfort, Lens Age 14 Days, Hour 10	Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 14 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE & FRESH ("Wow! My eyes feel incredible! I love this feeling.")	Day 15
Phase 3: Ocular Comfort, Lens Age 14 Days, End of Day	Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 14 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE & FRESH ("Wow! My eyes feel incredible! I love this feeling.")	Day 15
Phase 3: Ocular Comfort, Lens Age 27 Days, Hour 1	Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 27 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE & FRESH ("Wow! My eyes feel incredible! I love this feeling.")	Day 43
Phase 3: Ocular Comfort, Lens Age 27 Days, Hour 10	Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 27 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE & FRESH ("Wow! My eyes feel incredible! I love this feeling.")	Day 43
Phase 3: Ocular Comfort, Lens Age 27 Days, End of Day	Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 27 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE & FRESH ("Wow! My eyes feel incredible! I love this feeling.")	Day 43

Collaborators and Investigators

• Sponsor: CIBA VISION
• Collaborators: University of Waterloo
• Investigators: Study Director: Desmond Fonn, MOptom FAAO, University of Waterloo Centre for Contact Lens Research

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: September 9, 2010
• First Submitted That Met QC Criteria: September 9, 2010
• First Posted (Estimate): September 10, 2010

Study Record Updates

• Last Update Posted (Estimate): August 29, 2012
• Last Update Submitted That Met QC Criteria: July 26, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: P-373-C-006