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Ocular Comfort and the "Aging" Lens (ERBIUM)

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ClinicalTrials.gov Identifier: NCT01198600
Recruitment Status : Completed
First Posted : September 10, 2010
Results First Posted : August 29, 2012
Last Update Posted : August 29, 2012
Sponsor:
Collaborator:
University of Waterloo
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Refractive Error Device: Habitual contact lens Device: Lotrafilcon B contact lens Device: Contact lens cleaning and disinfecting system (ClearCare) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ocular Comfort and the "Aging" Lens (ERBIUM)
Study Start Date : July 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Erbium

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 1 [ Time Frame: Day 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.")

  2. Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 10 [ Time Frame: Day 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.")

  3. Phase 3: Ocular Comfort, Lens Age 1 Day, End of Day [ Time Frame: Day 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.")

  4. Phase 3: Ocular Comfort, Lens Age 14 Days, Hour 1 [ Time Frame: Day 15 ]
    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.")

  5. Phase 3: Ocular Comfort, Lens Age 14 Days, Hour 10 [ Time Frame: Day 15 ]
    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.")

  6. Phase 3: Ocular Comfort, Lens Age 14 Days, End of Day [ Time Frame: Day 15 ]
    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.")

  7. Phase 3: Ocular Comfort, Lens Age 27 Days, Hour 1 [ Time Frame: Day 43 ]
    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.")

  8. Phase 3: Ocular Comfort, Lens Age 27 Days, Hour 10 [ Time Frame: Day 43 ]
    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.")

  9. Phase 3: Ocular Comfort, Lens Age 27 Days, End of Day [ Time Frame: Day 43 ]
    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.")


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01198600


Locations
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Canada, Ontario
University of Waterloo
Waterloo, Ontario, Canada, N2L 3G1
Sponsors and Collaborators
CIBA VISION
University of Waterloo
Investigators
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Study Director: Desmond Fonn, MOptom FAAO University of Waterloo Centre for Contact Lens Research
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: CIBA VISION
ClinicalTrials.gov Identifier: NCT01198600    
Other Study ID Numbers: P-373-C-006
First Posted: September 10, 2010    Key Record Dates
Results First Posted: August 29, 2012
Last Update Posted: August 29, 2012
Last Verified: July 2012
Additional relevant MeSH terms:
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Refractive Errors
Eye Diseases