Trial Outcomes & Findings for Ocular Comfort and the "Aging" Lens (ERBIUM) (NCT NCT01198600)
NCT ID: NCT01198600
Last Updated: 2012-08-29
Results Overview
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.")
COMPLETED
NA
78 participants
Day 1
2012-08-29
Participant Flow
Participants were recruited from one Canadian research center.
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.
Participant milestones
| Measure |
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 new pair dispensed at Day 28.
|
Phase 1: Habitual Replacement, Then Habitual no Replacement
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.
|
Phase 2: Lotrafilcon B Replacement
Contact lenses worn for 56 days with replacement pair dispensed at Day 28.
|
Phase 3: Lotrafilcon B Replacement Replacement
Contact lenses worn for 43 days with replacement pair dispensed on Day 1 and Day 28.
|
|---|---|---|---|---|
|
Phase 1: Period One, 30 Days of Wear
STARTED
|
35
|
37
|
0
|
0
|
|
Phase 1: Period One, 30 Days of Wear
COMPLETED
|
33
|
36
|
0
|
0
|
|
Phase 1: Period One, 30 Days of Wear
NOT COMPLETED
|
2
|
1
|
0
|
0
|
|
Phase 1: Period Two, 30 Days of Wear
STARTED
|
32
|
36
|
0
|
0
|
|
Phase 1: Period Two, 30 Days of Wear
COMPLETED
|
32
|
35
|
0
|
0
|
|
Phase 1: Period Two, 30 Days of Wear
NOT COMPLETED
|
0
|
1
|
0
|
0
|
|
Phase 2: 56 Days of Wear
STARTED
|
0
|
0
|
67
|
0
|
|
Phase 2: 56 Days of Wear
COMPLETED
|
0
|
0
|
62
|
0
|
|
Phase 2: 56 Days of Wear
NOT COMPLETED
|
0
|
0
|
5
|
0
|
|
Phase 3: 43 Days of Wear
STARTED
|
0
|
0
|
0
|
38
|
|
Phase 3: 43 Days of Wear
COMPLETED
|
0
|
0
|
0
|
38
|
|
Phase 3: 43 Days of Wear
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
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 new pair dispensed at Day 28.
|
Phase 1: Habitual Replacement, Then Habitual no Replacement
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.
|
Phase 2: Lotrafilcon B Replacement
Contact lenses worn for 56 days with replacement pair dispensed at Day 28.
|
Phase 3: Lotrafilcon B Replacement Replacement
Contact lenses worn for 43 days with replacement pair dispensed on Day 1 and Day 28.
|
|---|---|---|---|---|
|
Phase 1: Period One, 30 Days of Wear
Inconvenience
|
1
|
0
|
0
|
0
|
|
Phase 1: Period One, 30 Days of Wear
Asymptomatic infiltrates
|
1
|
0
|
0
|
0
|
|
Phase 1: Period One, 30 Days of Wear
Unable to achieve acceptable comfort
|
0
|
1
|
0
|
0
|
|
Phase 1: Period Two, 30 Days of Wear
Inconvenience
|
0
|
1
|
0
|
0
|
|
Phase 2: 56 Days of Wear
Inconvenience
|
0
|
0
|
2
|
0
|
|
Phase 2: 56 Days of Wear
Relocation
|
0
|
0
|
2
|
0
|
|
Phase 2: 56 Days of Wear
Unable to achieve satisfactory comfort
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Ocular Comfort and the "Aging" Lens (ERBIUM)
Baseline characteristics by cohort
| Measure |
Overall
n=78 Participants
This reporting group includes all enrolled and dispensed participants.
|
|---|---|
|
Age Continuous
|
25.7 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
78 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: All enrolled and dispensed participants, Phase 3.
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.")
Outcome measures
| Measure |
Survivors: Lotrafilcon B/Replacement/Replacement
n=22 Participants
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.
|
Strugglers: Lotrafilcon B/Replacement/Replacement
n=16 Participants
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.
|
|---|---|---|
|
Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 1
|
76 Units on a scale
Standard Deviation 14
|
88 Units on a scale
Standard Deviation 14
|
PRIMARY outcome
Timeframe: Day 1Population: All enrolled and dispensed participants, Phase 3.
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.")
Outcome measures
| Measure |
Survivors: Lotrafilcon B/Replacement/Replacement
n=22 Participants
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.
|
Strugglers: Lotrafilcon B/Replacement/Replacement
n=16 Participants
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.
|
|---|---|---|
|
Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 10
|
69 Units on a scale
Standard Deviation 19
|
76 Units on a scale
Standard Deviation 19
|
PRIMARY outcome
Timeframe: Day 1Population: All enrolled and dispensed participants, Phase 3.
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.")
Outcome measures
| Measure |
Survivors: Lotrafilcon B/Replacement/Replacement
n=22 Participants
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.
|
Strugglers: Lotrafilcon B/Replacement/Replacement
n=16 Participants
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.
|
|---|---|---|
|
Phase 3: Ocular Comfort, Lens Age 1 Day, End of Day
|
65 Units on a scale
Standard Deviation 21
|
67 Units on a scale
Standard Deviation 21
|
PRIMARY outcome
Timeframe: Day 15Population: All enrolled and dispensed participants, Phase 3.
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.")
Outcome measures
| Measure |
Survivors: Lotrafilcon B/Replacement/Replacement
n=22 Participants
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.
|
Strugglers: Lotrafilcon B/Replacement/Replacement
n=16 Participants
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.
|
|---|---|---|
|
Phase 3: Ocular Comfort, Lens Age 14 Days, Hour 1
|
80 Units on a scale
Standard Deviation 14
|
79 Units on a scale
Standard Deviation 14
|
PRIMARY outcome
Timeframe: Day 15Population: All enrolled and dispensed participants, Phase 3.
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.")
Outcome measures
| Measure |
Survivors: Lotrafilcon B/Replacement/Replacement
n=22 Participants
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.
|
Strugglers: Lotrafilcon B/Replacement/Replacement
n=16 Participants
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.
|
|---|---|---|
|
Phase 3: Ocular Comfort, Lens Age 14 Days, Hour 10
|
77 Units on a scale
Standard Deviation 19
|
64 Units on a scale
Standard Deviation 19
|
PRIMARY outcome
Timeframe: Day 15Population: All enrolled and dispensed participants, Phase 3.
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.")
Outcome measures
| Measure |
Survivors: Lotrafilcon B/Replacement/Replacement
n=22 Participants
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.
|
Strugglers: Lotrafilcon B/Replacement/Replacement
n=16 Participants
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.
|
|---|---|---|
|
Phase 3: Ocular Comfort, Lens Age 14 Days, End of Day
|
72 Units on a scale
Standard Deviation 21
|
60 Units on a scale
Standard Deviation 21
|
PRIMARY outcome
Timeframe: Day 43Population: All enrolled and dispensed participants, Phase 3.
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.")
Outcome measures
| Measure |
Survivors: Lotrafilcon B/Replacement/Replacement
n=22 Participants
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.
|
Strugglers: Lotrafilcon B/Replacement/Replacement
n=16 Participants
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.
|
|---|---|---|
|
Phase 3: Ocular Comfort, Lens Age 27 Days, Hour 1
|
78 Units on a scale
Standard Deviation 14
|
74 Units on a scale
Standard Deviation 14
|
PRIMARY outcome
Timeframe: Day 43Population: All enrolled and dispensed participants, Phase 3.
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.")
Outcome measures
| Measure |
Survivors: Lotrafilcon B/Replacement/Replacement
n=22 Participants
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.
|
Strugglers: Lotrafilcon B/Replacement/Replacement
n=16 Participants
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.
|
|---|---|---|
|
Phase 3: Ocular Comfort, Lens Age 27 Days, Hour 10
|
72 Units on a scale
Standard Deviation 19
|
63 Units on a scale
Standard Deviation 19
|
PRIMARY outcome
Timeframe: Day 43Population: All enrolled and dispensed participants, Phase 3.
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.")
Outcome measures
| Measure |
Survivors: Lotrafilcon B/Replacement/Replacement
n=22 Participants
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.
|
Strugglers: Lotrafilcon B/Replacement/Replacement
n=16 Participants
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.
|
|---|---|---|
|
Phase 3: Ocular Comfort, Lens Age 27 Days, End of Day
|
66 Units on a scale
Standard Deviation 21
|
57 Units on a scale
Standard Deviation 21
|
Adverse Events
Habitual Contact Lens
Lotrafilcon B Contact Lens
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
R. Alan Landers, O.D., M.S., F.A.A.O.
Alcon Research
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER