Trial Outcomes & Findings for Comparison of Lotrafilcon B Lenses With Different Packaging Solutions (NCT NCT02699684)
NCT ID: NCT02699684
Last Updated: 2018-07-02
Results Overview
Overall lens fit was graded by the Investigator on a 5-point scale: -2 (unacceptably tight); -1 (acceptably tight); 0 (optimal fit); +1 (acceptable loose); +2 (unacceptable loose). 'No re-fit' criteria was satisfied if an acceptable or optimal overall lens fit, that was also within one grade of the habitual lens fit value, was achieved.
COMPLETED
NA
82 participants
Day 30, each product
2018-07-02
Participant Flow
Subjects were recruited from 1 study center located in the United Kingdom (UK).
Of the 82 enrolled, 6 subjects were exited as screen failures prior to randomization. One subject withdrew consent after randomization, but before exposure to product. This reporting group includes all randomized and exposed subjects (75).
Participant milestones
| Measure |
AOHG, Then AOA
Lotrafilcon B contact lenses with EOBO-41 worn first, followed by lotrafilcon B contact lenses worn second. Both products worn bilaterally (in both eyes) for 30 days and removed nightly for care using a hydrogen peroxide-based lens care solution.
|
AOA, Then AOHG
Lotrafilcon B contact lenses worn first, followed by lotrafilcon B contact lenses with EOBO-41 worn second. Both products worn bilaterally for 30 days and removed nightly for care using a hydrogen peroxide-based lens care solution.
|
|---|---|---|
|
Period 1, First 30 Days of Wear
STARTED
|
37
|
38
|
|
Period 1, First 30 Days of Wear
COMPLETED
|
37
|
38
|
|
Period 1, First 30 Days of Wear
NOT COMPLETED
|
0
|
0
|
|
Period 2, Second 30 Days of Wear
STARTED
|
37
|
38
|
|
Period 2, Second 30 Days of Wear
COMPLETED
|
36
|
38
|
|
Period 2, Second 30 Days of Wear
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
AOHG, Then AOA
Lotrafilcon B contact lenses with EOBO-41 worn first, followed by lotrafilcon B contact lenses worn second. Both products worn bilaterally (in both eyes) for 30 days and removed nightly for care using a hydrogen peroxide-based lens care solution.
|
AOA, Then AOHG
Lotrafilcon B contact lenses worn first, followed by lotrafilcon B contact lenses with EOBO-41 worn second. Both products worn bilaterally for 30 days and removed nightly for care using a hydrogen peroxide-based lens care solution.
|
|---|---|---|
|
Period 2, Second 30 Days of Wear
Adverse Event
|
1
|
0
|
Baseline Characteristics
Comparison of Lotrafilcon B Lenses With Different Packaging Solutions
Baseline characteristics by cohort
| Measure |
Overall
n=75 Participants
Lotrafilcon B contact lenses with EOBO-41 and lotrafilcon B contact lenses worn bilaterally during Period 1 and Period 2 in a crossover assignment, as randomized.
|
|---|---|
|
Age, Continuous
|
35.7 years
STANDARD_DEVIATION 10.30 • n=5 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 30, each productPopulation: Full Analysis Set. Number Analyzed is the number of subjects with non-missing response.
Overall lens fit was graded by the Investigator on a 5-point scale: -2 (unacceptably tight); -1 (acceptably tight); 0 (optimal fit); +1 (acceptable loose); +2 (unacceptable loose). 'No re-fit' criteria was satisfied if an acceptable or optimal overall lens fit, that was also within one grade of the habitual lens fit value, was achieved.
Outcome measures
| Measure |
AOHG Contact Lenses
n=75 Participants
Lotrafilcon B contact lenses with EOBO-41 worn bilaterally for 30 days in Period 1 or 2, as randomized
|
AOA Contact Lenses
n=74 Participants
Lotrafilcon B contact lenses worn bilaterally for 30 days in Period 1 or 2, as randomized
|
|---|---|---|
|
Percentage of Subjects Satisfying the "no Re-fit" Criteria in Both Eyes
|
93.3 percentage of subjects
|
94.6 percentage of subjects
|
SECONDARY outcome
Timeframe: Day 30, each productPopulation: Full Analysis Set. Only the right (OD) lenses were collected from a subset of subjects.
The contact lens was removed from the eye. Cholesterol deposits were extracted and measured in micrograms (μg) per lens. Lower deposits indicate increased lens performance. Only one eye (right eye) contributed to the analysis.
Outcome measures
| Measure |
AOHG Contact Lenses
n=32 Participants
Lotrafilcon B contact lenses with EOBO-41 worn bilaterally for 30 days in Period 1 or 2, as randomized
|
AOA Contact Lenses
n=32 Participants
Lotrafilcon B contact lenses worn bilaterally for 30 days in Period 1 or 2, as randomized
|
|---|---|---|
|
Mean Ex Vivo Total Cholesterol Uptake After 30 Days of Wear
|
0.44 μg
Standard Deviation 0.231
|
0.27 μg
Standard Deviation 0.173
|
SECONDARY outcome
Timeframe: Hour 0 (Lens Insertion) to Hour 12 on Day 1Population: Full Analysis Set. Number Analyzed is the number of eyes with non-missing response.
MPA (the minimum area of the contact lens surface (expressed in %) protected by the tear film between two natural blinks) was assessed by the Investigator during the interblink period using the Tearscope® lighting system. Higher values indicate a more stable tear film in front of the lens. This Outcome Measure was pre-specified for AOHG only. Both eyes contributed to the analysis.
Outcome measures
| Measure |
AOHG Contact Lenses
n=90 Eyes
Lotrafilcon B contact lenses with EOBO-41 worn bilaterally for 30 days in Period 1 or 2, as randomized
|
AOA Contact Lenses
Lotrafilcon B contact lenses worn bilaterally for 30 days in Period 1 or 2, as randomized
|
|---|---|---|
|
Change From Insertion in Minimum Protected Area (MPA)
Insertion (Hour 0)
|
86.839 percentage of contact lens surface area
Standard Deviation 24.775
|
—
|
|
Change From Insertion in Minimum Protected Area (MPA)
Change from Insertion (Hour 12 - Hour 0)
|
4.396 percentage of contact lens surface area
Standard Deviation 23.060
|
—
|
Adverse Events
Pretreatment
AOHG Contact Lenses
AOA Contact Lenses
Serious adverse events
| Measure |
Pretreatment
n=82 participants at risk
All subjects who consented to participate in the study prior to initiation of study treatment
|
AOHG Contact Lenses
n=75 participants at risk
All subjects exposed to AOHG contact lenses
|
AOA Contact Lenses
n=75 participants at risk
All subjects exposed to AOA contact lenses
|
|---|---|---|---|
|
Gastrointestinal disorders
Food Poisoning
|
0.00%
0/82 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 74 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device.
|
1.3%
1/75 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 74 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device.
|
0.00%
0/75 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 74 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device.
|
Other adverse events
Adverse event data not reported
Additional Information
Sr. Global Brand Medical Affairs Lead, GCRA
Alcon, A Novartis Division
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER