Trial Outcomes & Findings for Multi-Center 2-Week Clinical Evaluation of Three Silicone Hydrogel Contact Lenses (NCT NCT01244516)
NCT ID: NCT01244516
Last Updated: 2018-06-19
Results Overview
Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.
COMPLETED
NA
540 participants
after 2 weeks of contact lens wear
2018-06-19
Participant Flow
There were thirty-five sites recruited in the US. There were 540 subjects recruited with 520 enrolled and randomized. The study was a 2-week, randomized, single-masked (subjects), parallel arm, bilateral dispensing study. The subject group was expected to be representative of a cross-section of the population within the US contact lens market.
There were 20 subjects who did not meet the inclusion or did meet the exclusion criteria. There were 10 screen failures and 10 who wore spectacles to baseline visit invoking the exclusion criteria.
Participant milestones
| Measure |
Galyfilcon A
Subjects that were randomized to receive the galyfilcon A lens with a base curve of 8.30 throughout the entire course of the study.
|
Lotrafilcon B
Subjects that were randomized to wear lotrafilcon B lens throughout the course of the study.
|
Comfilcon A
Subjects that were randomized to wear comfilcon A lens throughout the course of the study.
|
|---|---|---|---|
|
Period 1 (Baseline to 1-week Visit)
STARTED
|
170
|
177
|
173
|
|
Period 1 (Baseline to 1-week Visit)
COMPLETED
|
166
|
171
|
170
|
|
Period 1 (Baseline to 1-week Visit)
NOT COMPLETED
|
4
|
6
|
3
|
|
Period 2 (1-week to 2-week Visit)
STARTED
|
166
|
171
|
170
|
|
Period 2 (1-week to 2-week Visit)
COMPLETED
|
163
|
170
|
168
|
|
Period 2 (1-week to 2-week Visit)
NOT COMPLETED
|
3
|
1
|
2
|
Reasons for withdrawal
| Measure |
Galyfilcon A
Subjects that were randomized to receive the galyfilcon A lens with a base curve of 8.30 throughout the entire course of the study.
|
Lotrafilcon B
Subjects that were randomized to wear lotrafilcon B lens throughout the course of the study.
|
Comfilcon A
Subjects that were randomized to wear comfilcon A lens throughout the course of the study.
|
|---|---|---|---|
|
Period 1 (Baseline to 1-week Visit)
Protocol Violation
|
4
|
5
|
2
|
|
Period 1 (Baseline to 1-week Visit)
Poor Vision
|
0
|
1
|
0
|
|
Period 1 (Baseline to 1-week Visit)
Poor comfort
|
0
|
0
|
1
|
|
Period 2 (1-week to 2-week Visit)
Adverse Event
|
2
|
0
|
0
|
|
Period 2 (1-week to 2-week Visit)
Protocol Violation
|
1
|
0
|
1
|
|
Period 2 (1-week to 2-week Visit)
Lost to Follow-up
|
0
|
1
|
0
|
|
Period 2 (1-week to 2-week Visit)
Poor Comfort
|
0
|
0
|
1
|
Baseline Characteristics
Multi-Center 2-Week Clinical Evaluation of Three Silicone Hydrogel Contact Lenses
Baseline characteristics by cohort
| Measure |
Galyfilcon A
n=163 Participants
Subjects that were randomized to receive the galyfilcon A lens with a base curve of 8.30 throughout the entire course of the study.
|
Lotrafilcon B
n=170 Participants
Subjects that were randomized to wear lotrafilcon B lens throughout the course of the study.
|
Comfilcon A
n=168 Participants
Subjects that were randomized to wear comfilcon A lens throughout the course of the study.
|
Total
n=501 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
28.8 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
28.3 years
STANDARD_DEVIATION 5.6 • n=7 Participants
|
27.4 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
28.2 years
STANDARD_DEVIATION 5.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
108 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
341 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
160 Participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
163 Participants
n=5 Participants
|
170 Participants
n=7 Participants
|
168 Participants
n=5 Participants
|
501 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: after 2 weeks of contact lens wearPopulation: Analysis is on those subjects who completed the study (n=501).
Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.
Outcome measures
| Measure |
Galyfilcon A
n=163 Participants
Subjects that were randomized to receive the galyfilcon A lens with a base curve of 8.30 throughout the entire course of the study.
|
Lotrafilcon B
n=170 Participants
Subjects that were randomized to wear lotrafilcon B lens throughout the course of the study.
|
Comfilcon A
n=168 Participants
Subjects that were randomized to wear comfilcon A lens throughout the course of the study.
|
|---|---|---|---|
|
Overall Subjective Comfort
|
51.7 CLUE score
Standard Error 2.1
|
51.3 CLUE score
Standard Error 2.0
|
51.3 CLUE score
Standard Error 2.0
|
PRIMARY outcome
Timeframe: after 2 weeks of contact lens wearPopulation: Analysis is on those subjects who completed the study (n=501).
Investigator evaluated corneal staining. Percent of eyes with corneal staining presence or absence is evaluated.
Outcome measures
| Measure |
Galyfilcon A
n=326 Eyes
Subjects that were randomized to receive the galyfilcon A lens with a base curve of 8.30 throughout the entire course of the study.
|
Lotrafilcon B
n=340 Eyes
Subjects that were randomized to wear lotrafilcon B lens throughout the course of the study.
|
Comfilcon A
n=336 Eyes
Subjects that were randomized to wear comfilcon A lens throughout the course of the study.
|
|---|---|---|---|
|
Corneal Staining
No corneal staining
|
78.5 percentage of eyes
|
67.1 percentage of eyes
|
66.1 percentage of eyes
|
|
Corneal Staining
With corneal staining
|
21.5 percentage of eyes
|
32.9 percentage of eyes
|
33.9 percentage of eyes
|
SECONDARY outcome
Timeframe: after 2 weeks of contact lens wearPopulation: Analysis is on those subjects who completed the study (n=331) and where assigned to these two arms. Analysis is restricted to these two arms for this outcome as specified per protocol.
Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0 to 120. Only galyficlon A and comfilcon A were evaluated.
Outcome measures
| Measure |
Galyfilcon A
n=163 Participants
Subjects that were randomized to receive the galyfilcon A lens with a base curve of 8.30 throughout the entire course of the study.
|
Lotrafilcon B
n=168 Participants
Subjects that were randomized to wear lotrafilcon B lens throughout the course of the study.
|
Comfilcon A
Subjects that were randomized to wear comfilcon A lens throughout the course of the study.
|
|---|---|---|---|
|
Overall Subjective Lens Handling
|
64.3 CLUE score
Standard Error 1.6
|
59.8 CLUE score
Standard Error 1.6
|
—
|
Adverse Events
Galyfilcon A
Lotrafilcon B
Comfilcon A
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication required agreement and written authorization from the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER