Ocular Comfort and the "Aging" Lens (ERBIUM)

Not Applicable

Completed

• Conditions: Refractive Error
• Interventions: Device: Habitual contact lens; Device: Lotrafilcon B contact lens; Device: Contact lens cleaning and disinfecting system (ClearCare)

• Registration Number: NCT01198600
• Lead Sponsor: CIBA VISION

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.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-09-09
• Study First Submitted QC: 2010-09-09
• Study First Posted: 2010-09-10
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2012-07
• Results First Submitted: 2012-07-26
• Results First Submitted QC: 2012-07-26
• Last Update Submitted: 2012-07-26
• Results First Posted: 2012-08-29
• Last Update Posted: 2012-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Phase 1: Habitual no Replacement, then Habitual Replacement	Habitual contact lens	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.
Phase 1: Habitual Replacement, then Habitual no Replacement	Habitual contact lens	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.
Phase 2: Lotrafilcon B Replacement	Lotrafilcon B contact lens	Contact lenses worn for 56 days with replacement pair dispensed at Day 28.
Phase 2: Lotrafilcon B Replacement	Contact lens cleaning and disinfecting system (ClearCare)	Contact lenses worn for 56 days with replacement pair dispensed at Day 28.
Phase 3: Lotrafilcon B Replacement Replacement	Lotrafilcon B contact lens	Contact lenses worn for 43 days with replacement pair dispensed at Day 1 and Day 28.
Phase 3: Lotrafilcon B Replacement Replacement	Contact lens cleaning and disinfecting system (ClearCare)	Contact lenses worn for 43 days with replacement pair dispensed at Day 1 and Day 28.

Primary Outcome Measures

Name	Time	Method
Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 1	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.")
Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 10	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.")
Phase 3: Ocular Comfort, Lens Age 1 Day, End of Day	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.")
Phase 3: Ocular Comfort, Lens Age 14 Days, Hour 1	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.")
Phase 3: Ocular Comfort, Lens Age 14 Days, Hour 10	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.")
Phase 3: Ocular Comfort, Lens Age 14 Days, End of Day	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.")
Phase 3: Ocular Comfort, Lens Age 27 Days, Hour 1	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.")
Phase 3: Ocular Comfort, Lens Age 27 Days, Hour 10	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.")
Phase 3: Ocular Comfort, Lens Age 27 Days, End of Day	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.")

Trial Locations

Locations (1)

University of Waterloo; 🇨🇦 Waterloo, Ontario, Canada