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Ocular Comfort and the "Aging" Lens (ERBIUM)

Primary Purpose

Refractive Error

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Habitual contact lens
Lotrafilcon B contact lens
Contact lens cleaning and disinfecting system (ClearCare)
Sponsored by
CIBA VISION
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractive Error

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Waterloo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Phase 1: Habitual no Replacement, then Habitual Replacement

Phase 1: Habitual Replacement, then Habitual no Replacement

Phase 2: Lotrafilcon B Replacement

Phase 3: Lotrafilcon B Replacement Replacement

Arm Description

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.

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.

Contact lenses worn for 56 days with replacement pair dispensed at Day 28.

Contact lenses worn for 43 days with replacement pair dispensed at Day 1 and Day 28.

Outcomes

Primary Outcome Measures

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.")
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.")
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.")
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.")
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.")
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.")
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.")
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.")
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.")

Secondary Outcome Measures

Full Information

First Posted
September 9, 2010
Last Updated
July 26, 2012
Sponsor
CIBA VISION
Collaborators
University of Waterloo
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1. Study Identification

Unique Protocol Identification Number
NCT01198600
Brief Title
Ocular Comfort and the "Aging" Lens (ERBIUM)
Official Title
Ocular Comfort and the "Aging" Lens (ERBIUM)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CIBA VISION
Collaborators
University of Waterloo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Error

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase 1: Habitual no Replacement, then Habitual Replacement
Arm Type
Other
Arm Description
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.
Arm Title
Phase 1: Habitual Replacement, then Habitual no Replacement
Arm Type
Other
Arm Description
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.
Arm Title
Phase 2: Lotrafilcon B Replacement
Arm Type
Other
Arm Description
Contact lenses worn for 56 days with replacement pair dispensed at Day 28.
Arm Title
Phase 3: Lotrafilcon B Replacement Replacement
Arm Type
Other
Arm Description
Contact lenses worn for 43 days with replacement pair dispensed at Day 1 and Day 28.
Intervention Type
Device
Intervention Name(s)
Habitual contact lens
Intervention Description
Hydrogel or silicone hydrogel contact lens per participant's habitual brand and prescription
Intervention Type
Device
Intervention Name(s)
Lotrafilcon B contact lens
Other Intervention Name(s)
AIR OPTIX AQUA
Intervention Description
Commercially marketed silicone hydrogel contact lens
Intervention Type
Device
Intervention Name(s)
Contact lens cleaning and disinfecting system (ClearCare)
Other Intervention Name(s)
CLEARCARE
Intervention Description
Commercially marketed, hydrogen peroxide-based contact lens care system
Primary Outcome Measure Information:
Title
Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 1
Description
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.")
Time Frame
Day 1
Title
Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 10
Description
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.")
Time Frame
Day 1
Title
Phase 3: Ocular Comfort, Lens Age 1 Day, End of Day
Description
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.")
Time Frame
Day 1
Title
Phase 3: Ocular Comfort, Lens Age 14 Days, Hour 1
Description
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.")
Time Frame
Day 15
Title
Phase 3: Ocular Comfort, Lens Age 14 Days, Hour 10
Description
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.")
Time Frame
Day 15
Title
Phase 3: Ocular Comfort, Lens Age 14 Days, End of Day
Description
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.")
Time Frame
Day 15
Title
Phase 3: Ocular Comfort, Lens Age 27 Days, Hour 1
Description
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.")
Time Frame
Day 43
Title
Phase 3: Ocular Comfort, Lens Age 27 Days, Hour 10
Description
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.")
Time Frame
Day 43
Title
Phase 3: Ocular Comfort, Lens Age 27 Days, End of Day
Description
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.")
Time Frame
Day 43

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Desmond Fonn, MOptom FAAO
Organizational Affiliation
University of Waterloo Centre for Contact Lens Research
Official's Role
Study Director
Facility Information:
Facility Name
University of Waterloo
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Ocular Comfort and the "Aging" Lens (ERBIUM)

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