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Completed

NCT Number: NCT01198600

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.

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Key information

Conditions

Refractive Error Eye Diseases Refractive Errors

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Habitual contact lens

Device

Hydrogel or silicone hydrogel contact lens per participant's habitual brand and prescription

Lotrafilcon B contact lens

Device

Commercially marketed silicone hydrogel contact lens

Other names: AIR OPTIX AQUA

Contact lens cleaning and disinfecting system (ClearCare)

Device

Commercially marketed, hydrogen peroxide-based contact lens care system

Other names: CLEARCARE

Primary outcomes

  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.")

Sponsors and collaborators

Lead sponsor

CIBA VISION

Industry

Collaborators

  • University of Waterloo

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 10, 2010
Registry last updated
Aug 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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