Ocular Comfort and the "Aging" Lens (ERBIUM)

• Sponsor: CIBA VISION (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01198600
• Collaborator: University of Waterloo (Other)
• Enrollment: 78
• Location: 1
• Arms: 4
• Duration (Months): 12
• Patients Per Site Per Month: 6.5

Study Details

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.

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)	N/A

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

• Study Type: Interventional
• 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: Jul 1, 2010
• Actual Primary Completion Date: Jul 1, 2011
• Actual Study Completion Date: Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Other: 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
Other: 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
Other: 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 Names: AIR OPTIX AQUA ; Device: Contact lens cleaning and disinfecting system (ClearCare); Commercially marketed, hydrogen peroxide-based contact lens care system; Other Names: CLEARCARE
Other: 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 Names: AIR OPTIX AQUA ; Device: Contact lens cleaning and disinfecting system (ClearCare); Commercially marketed, hydrogen peroxide-based contact lens care system; Other Names: CLEARCARE

Outcome Measures

Primary Outcome Measures

1. 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.")

2. 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.")

3. 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.")

4. 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.")

5. 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.")

6. 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.")

7. 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.")

8. 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.")

9. 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.")

Eligibility Criteria

Criteria

• Ages Eligible for Study: 17 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University of Waterloo	Waterloo	Ontario	Canada	N2L 3G1

Sponsors and Collaborators

• CIBA VISION
• University of Waterloo

Investigators

• Study Director: Desmond Fonn, MOptom FAAO, University of Waterloo Centre for Contact Lens Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: CIBA VISION
• ClinicalTrials.gov Identifier: NCT01198600
• Other Study ID Numbers: P-373-C-006
• First Posted: Sep 10, 2010
• Last Update Posted: Aug 29, 2012
• Last Verified: Jul 1, 2012

• Additional relevant MeSH terms: Refractive Errors

Study Results

Participant Flow

Recruitment Details	Participants were recruited from one Canadian research center.
Pre-assignment Detail	Baseline characteristics are presented for all enrolled participants: 78. The participant flow chart includes all enrolled and dispensed participants: 72. Six participants were enrolled but not dispensed.

Arm/Group Title	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/Group 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 new pair dispensed at Day 28.	Contact lenses per participant's habitual prescription worn for 30 days with a new 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 on Day 1 and Day 28.
Period Title: Phase 1: Period One, 30 Days of Wear
STARTED	35	37	0	0
COMPLETED	33	36	0	0
NOT COMPLETED	2	1	0	0
Period Title: Phase 1: Period One, 30 Days of Wear
STARTED	32	36	0	0
COMPLETED	32	35	0	0
NOT COMPLETED	0	1	0	0
Period Title: Phase 1: Period One, 30 Days of Wear
STARTED	0	0	67	0
COMPLETED	0	0	62	0
NOT COMPLETED	0	0	5	0
Period Title: Phase 1: Period One, 30 Days of Wear
STARTED	0	0	0	38
COMPLETED	0	0	0	38
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	Overall
Arm/Group Description	This reporting group includes all enrolled and dispensed participants.
Overall Participants	78
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	25.7 (7.9)
Sex: Female, Male (Count of Participants)
Female	65 83.3%
Male	13 16.7%
Region of Enrollment (participants) [Number]
Canada	78 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All enrolled and dispensed participants, Phase 3.

Arm/Group Title	Survivors: Lotrafilcon B/Replacement/Replacement	Strugglers: Lotrafilcon B/Replacement/Replacement
Arm/Group Description	Contact lenses worn for 43 days, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15 during Phase 3. "Survivors" were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2.	Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. "Strugglers" were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2.
Measure Participants	22	16
Mean (Standard Deviation) [Units on a scale]	76 (14)	88 (14)

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All enrolled and dispensed participants, Phase 3.

Arm/Group Title	Survivors: Lotrafilcon B/Replacement/Replacement	Strugglers: Lotrafilcon B/Replacement/Replacement
Arm/Group Description	Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. "Survivors" were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2.	Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. "Strugglers" were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2.
Measure Participants	22	16
Mean (Standard Deviation) [Units on a scale]	69 (19)	76 (19)

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All enrolled and dispensed participants, Phase 3.

Arm/Group Title	Survivors: Lotrafilcon B/Replacement/Replacement	Strugglers: Lotrafilcon B/Replacement/Replacement
Arm/Group Description	Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. "Survivors" were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2.	Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. "Strugglers" were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2.
Measure Participants	22	16
Mean (Standard Deviation) [Units on a scale]	65 (21)	67 (21)

4. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All enrolled and dispensed participants, Phase 3.

Arm/Group Title	Survivors: Lotrafilcon B/Replacement/Replacement	Strugglers: Lotrafilcon B/Replacement/Replacement
Arm/Group Description	Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. "Survivors" were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2.	Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. "Strugglers" were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2.of Phase 2.
Measure Participants	22	16
Mean (Standard Deviation) [Units on a scale]	80 (14)	79 (14)

5. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All enrolled and dispensed participants, Phase 3.

Arm/Group Title	Survivors: Lotrafilcon B/Replacement/Replacement	Strugglers: Lotrafilcon B/Replacement/Replacement
Arm/Group Description	Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. "Survivors" were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2.	Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. "Strugglers" were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2.
Measure Participants	22	16
Mean (Standard Deviation) [Units on a scale]	77 (19)	64 (19)

6. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All enrolled and dispensed participants, Phase 3.

Arm/Group Title	Survivors: Lotrafilcon B/Replacement/Replacement	Strugglers: Lotrafilcon B/Replacement/Replacement
Arm/Group Description	Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. "Survivors" were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2.	Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. "Strugglers" were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2.
Measure Participants	22	16
Mean (Standard Deviation) [Units on a scale]	72 (21)	60 (21)

7. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All enrolled and dispensed participants, Phase 3.

Arm/Group Title	Survivors: Lotrafilcon B/Replacement/Replacement	Strugglers: Lotrafilcon B/Replacement/Replacement
Arm/Group Description	Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. "Survivors" were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2.	Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. "Strugglers" were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2.
Measure Participants	22	16
Mean (Standard Deviation) [Units on a scale]	78 (14)	74 (14)

8. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All enrolled and dispensed participants, Phase 3.

Arm/Group Title	Survivors: Lotrafilcon B/Replacement/Replacement	Strugglers: Lotrafilcon B/Replacement/Replacement
Arm/Group Description	Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. "Survivors" were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2.	Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. "Strugglers" were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2.
Measure Participants	22	16
Mean (Standard Deviation) [Units on a scale]	72 (19)	63 (19)

9. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All enrolled and dispensed participants, Phase 3.

Arm/Group Title	Survivors: Lotrafilcon B/Replacement/Replacement	Strugglers: Lotrafilcon B/Replacement/Replacement
Arm/Group Description	Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. "Survivors" were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2.	Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. "Strugglers" were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2.
Measure Participants	22	16
Mean (Standard Deviation) [Units on a scale]	66 (21)	57 (21)

Adverse Events

Time Frame	Adverse events were collected for the duration of the study: 8-JUL-2010 to 19-JUL-2011.
Adverse Event Reporting Description	The safety population includes all enrolled and dispensed participants.
Arm/Group Title	Habitual Contact Lens		Lotrafilcon B Contact Lens
Arm/Group Description	Contact lens per participant's habitual prescription worn for two 30-day periods in Phase 1, with a replacement dispensed at Day 28 in either Period 1 or Period 2.		Contact lens worn for 56 days with a replacement dispensed at Day 28 in Phase 2, followed by 43 days in Phase 3 with a replacement dispensed at Day 1 and Day 14.
All Cause Mortality
	Habitual Contact Lens		Lotrafilcon B Contact Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Habitual Contact Lens		Lotrafilcon B Contact Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/78 (0%)		0/67 (0%)
Other (Not Including Serious) Adverse Events
	Habitual Contact Lens		Lotrafilcon B Contact Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/78 (0%)		0/67 (0%)

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

For a period of 10 years, the clinical investigator must hold all trial-related information and documents confidential and must agree to obtain sponsor's written consent before discussing, presenting, publicizing, or otherwise disclosing any preclinical and/or clinical data or impressions from this trial.