Ocular Comfort and the "Aging" Lens (ERBIUM)

This study has been completed.
Sponsor:
Collaborator:
University of Waterloo
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT01198600
First received: September 9, 2010
Last updated: July 26, 2012
Last verified: July 2012
  Purpose

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


Condition Intervention
Refractive Error
Device: Habitual contact lens
Device: Lotrafilcon B contact lens
Device: Contact lens cleaning and disinfecting system (ClearCare)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ocular Comfort and the "Aging" Lens (ERBIUM)

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 1 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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.")

  • Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 10 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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.")

  • Phase 3: Ocular Comfort, Lens Age 1 Day, End of Day [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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.")

  • Phase 3: Ocular Comfort, Lens Age 14 Days, Hour 1 [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
    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.")

  • Phase 3: Ocular Comfort, Lens Age 14 Days, Hour 10 [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
    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.")

  • Phase 3: Ocular Comfort, Lens Age 14 Days, End of Day [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
    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.")

  • Phase 3: Ocular Comfort, Lens Age 27 Days, Hour 1 [ Time Frame: Day 43 ] [ Designated as safety issue: No ]
    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.")

  • Phase 3: Ocular Comfort, Lens Age 27 Days, Hour 10 [ Time Frame: Day 43 ] [ Designated as safety issue: No ]
    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.")

  • Phase 3: Ocular Comfort, Lens Age 27 Days, End of Day [ Time Frame: Day 43 ] [ Designated as safety issue: No ]
    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.")


Enrollment: 78
Study Start Date: July 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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 Name: AIR OPTIX AQUA
Device: Contact lens cleaning and disinfecting system (ClearCare)
Commercially marketed, hydrogen peroxide-based contact lens care system
Other Name: CLEARCARE
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 Name: AIR OPTIX AQUA
Device: Contact lens cleaning and disinfecting system (ClearCare)
Commercially marketed, hydrogen peroxide-based contact lens care system
Other Name: 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.

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01198600

Locations
Canada, Ontario
University of Waterloo
Waterloo, Ontario, Canada, N2L 3G1
Sponsors and Collaborators
CIBA VISION
University of Waterloo
Investigators
Study Director: Desmond Fonn, MOptom FAAO University of Waterloo Centre for Contact Lens Research
  More Information

No publications provided

Responsible Party: Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier: NCT01198600     History of Changes
Other Study ID Numbers: P-373-C-006
Study First Received: September 9, 2010
Results First Received: July 26, 2012
Last Updated: July 26, 2012
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 17, 2014