NCT01198600

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 10, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

August 29, 2012

Completed
Last Updated

August 29, 2012

Status Verified

July 1, 2012

Enrollment Period

1 year

First QC Date

September 9, 2010

Results QC Date

July 26, 2012

Last Update Submit

July 26, 2012

Conditions

Refractive Error

Outcome Measures

Primary Outcomes (9)

  • 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

Study Arms (4)

Phase 1: Habitual no Replacement, then Habitual Replacement

OTHER

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

Phase 1: Habitual Replacement, then Habitual no Replacement

OTHER

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

Phase 2: Lotrafilcon B Replacement

OTHER

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

Device: Lotrafilcon B contact lensDevice: Contact lens cleaning and disinfecting system (ClearCare)

Phase 3: Lotrafilcon B Replacement Replacement

OTHER

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

Device: Lotrafilcon B contact lensDevice: Contact lens cleaning and disinfecting system (ClearCare)

Interventions

Habitual contact lensDEVICE

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

Phase 1: Habitual Replacement, then Habitual no ReplacementPhase 1: Habitual no Replacement, then Habitual Replacement
Lotrafilcon B contact lensDEVICE

Commercially marketed silicone hydrogel contact lens

Also known as: AIR OPTIX AQUA
Phase 2: Lotrafilcon B ReplacementPhase 3: Lotrafilcon B Replacement Replacement
Contact lens cleaning and disinfecting system (ClearCare)DEVICE

Commercially marketed, hydrogen peroxide-based contact lens care system

Also known as: CLEARCARE
Phase 2: Lotrafilcon B ReplacementPhase 3: Lotrafilcon B Replacement Replacement

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Limitations and Caveats

The current study design and sample size was not able to uncover clinically meaningful differences between survivors and strugglers. There is considerable individual variation in lens performance with age, which requires further investigation.

Results Point of Contact

Title
R. Alan Landers, O.D., M.S., F.A.A.O.
Organization
Alcon Research
1-800-241-7629

Study Officials

  • Desmond Fonn, MOptom FAAO

    University of Waterloo Centre for Contact Lens Research

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2010

First Posted

September 10, 2010

Study Start

July 1, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

August 29, 2012

Results First Posted

August 29, 2012

Record last verified: 2012-07

Locations

CA(1)