Trial Outcomes & Findings for A Comparative Study of Two Daily Disposable Contact Lenses in Higher Myopia Subjects (NCT NCT02066922)
NCT ID: NCT02066922
Last Updated: 2015-06-08
Results Overview
Corneal curvature (horizontal and vertical keratometry values on the same eye) was measured using a calibrated keratometer prior to study lens dispense (Day 1) and approximately 15 minutes after study lens removal following 8 hours of wear (Week 1). Minus values in change-from-baseline indicate corneal flattening.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
Dispense (Day 1 of lens wear), Week 1 (Day 8 of lens wear)
Results posted on
2015-06-08
Participant Flow
Participants were recruited from 2 study centers located in the US and 2 study centers located in Germany.
Of the 19 enrolled, 4 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants (15).
Participant milestones
| Measure |
DAILIES TOTAL1/TRUEYE
Delefilcon A and narafilcon A contact lenses (1 in each eye) worn in a daily wear, daily disposable mode approximately 8 hours a day for approximately 1 week.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
DAILIES TOTAL1/TRUEYE
Delefilcon A and narafilcon A contact lenses (1 in each eye) worn in a daily wear, daily disposable mode approximately 8 hours a day for approximately 1 week.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
A Comparative Study of Two Daily Disposable Contact Lenses in Higher Myopia Subjects
Baseline characteristics by cohort
| Measure |
DAILIES TOTAL1/TRUEYE
n=15 Participants
Delefilcon A and narafilcon A contact lenses (1 in each eye) worn in a daily wear, daily disposable mode approximately 8 hours a day for approximately 1 week.
|
|---|---|
|
Age, Continuous
|
34.2 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Dispense (Day 1 of lens wear), Week 1 (Day 8 of lens wear)Population: This analysis group includes all randomized participants with data present at visit.
Corneal curvature (horizontal and vertical keratometry values on the same eye) was measured using a calibrated keratometer prior to study lens dispense (Day 1) and approximately 15 minutes after study lens removal following 8 hours of wear (Week 1). Minus values in change-from-baseline indicate corneal flattening.
Outcome measures
| Measure |
DAILIES TOTAL1
n=14 Participants
Delefilcon A contact lens worn in 1 eye approximately 8 hours a day for 1 week
|
TRUEYE
n=14 Participants
Narafilcon A contact lens worn in 1 eye approximately 8 hours a day for 1 week.
|
|---|---|---|
|
Change in Average Central Corneal Curvature From Dispense at Week 1
|
-0.44 diopters
Standard Deviation 0.46
|
-0.11 diopters
Standard Deviation 0.26
|
SECONDARY outcome
Timeframe: Baseline, Week 1 (Day 8 of lens wear)Population: This analysis group includes all randomized participants with data present at visit.
Subjective manifest refraction was assessed using a phoropter or trial frame set with the subject's current prescription at Baseline (Visit 2) after a 2-day washout period and approximately 15 minutes after study lens removal following 8 hours of wear (Week 1). Spectacle over-refraction, if required, was performed. Higher myopia is indicated by larger negative values in manifest refraction.
Outcome measures
| Measure |
DAILIES TOTAL1
n=14 Participants
Delefilcon A contact lens worn in 1 eye approximately 8 hours a day for 1 week
|
TRUEYE
n=14 Participants
Narafilcon A contact lens worn in 1 eye approximately 8 hours a day for 1 week.
|
|---|---|---|
|
Number of Eyes With Change of >1.00 Diopter (D) in Spherical Equivalent of Subjective Refraction From Baseline at Week 1
|
3 Eyes
|
1 Eyes
|
Adverse Events
DAILIES TOTAL1
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
TRUEYE
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DAILIES TOTAL1
n=15 participants at risk
Delefilcon A contact lens worn in 1 eye approximately 8 hours a day for 1 week
|
TRUEYE
n=15 participants at risk
Narafilcon A contact lens worn in 1 eye approximately 8 hours a day for 1 week
|
|---|---|---|
|
Eye disorders
Foreign body sensation in eyes
|
6.7%
1/15 • Adverse events (AEs) were collected for the duration of the study (March, 2014 - May, 2014). This analysis group includes all participants/eyes exposed to the study products. Trial-fit lenses were not considered study products.
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 investigational medical device.
|
0.00%
0/15 • Adverse events (AEs) were collected for the duration of the study (March, 2014 - May, 2014). This analysis group includes all participants/eyes exposed to the study products. Trial-fit lenses were not considered study products.
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 investigational medical device.
|
|
Eye disorders
Metamorphopsia
|
6.7%
1/15 • Adverse events (AEs) were collected for the duration of the study (March, 2014 - May, 2014). This analysis group includes all participants/eyes exposed to the study products. Trial-fit lenses were not considered study products.
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 investigational medical device.
|
6.7%
1/15 • Adverse events (AEs) were collected for the duration of the study (March, 2014 - May, 2014). This analysis group includes all participants/eyes exposed to the study products. Trial-fit lenses were not considered study products.
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 investigational medical device.
|
|
Musculoskeletal and connective tissue disorders
Myokymia
|
6.7%
1/15 • Adverse events (AEs) were collected for the duration of the study (March, 2014 - May, 2014). This analysis group includes all participants/eyes exposed to the study products. Trial-fit lenses were not considered study products.
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 investigational medical device.
|
6.7%
1/15 • Adverse events (AEs) were collected for the duration of the study (March, 2014 - May, 2014). This analysis group includes all participants/eyes exposed to the study products. Trial-fit lenses were not considered study products.
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 investigational medical device.
|
|
Eye disorders
Ocular discomfort
|
6.7%
1/15 • Adverse events (AEs) were collected for the duration of the study (March, 2014 - May, 2014). This analysis group includes all participants/eyes exposed to the study products. Trial-fit lenses were not considered study products.
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 investigational medical device.
|
0.00%
0/15 • Adverse events (AEs) were collected for the duration of the study (March, 2014 - May, 2014). This analysis group includes all participants/eyes exposed to the study products. Trial-fit lenses were not considered study products.
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 investigational medical device.
|
|
Eye disorders
Punctate keratitis
|
6.7%
1/15 • Adverse events (AEs) were collected for the duration of the study (March, 2014 - May, 2014). This analysis group includes all participants/eyes exposed to the study products. Trial-fit lenses were not considered study products.
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 investigational medical device.
|
0.00%
0/15 • Adverse events (AEs) were collected for the duration of the study (March, 2014 - May, 2014). This analysis group includes all participants/eyes exposed to the study products. Trial-fit lenses were not considered study products.
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 investigational medical device.
|
|
Investigations
Topography corneal abnormal
|
6.7%
1/15 • Adverse events (AEs) were collected for the duration of the study (March, 2014 - May, 2014). This analysis group includes all participants/eyes exposed to the study products. Trial-fit lenses were not considered study products.
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 investigational medical device.
|
0.00%
0/15 • Adverse events (AEs) were collected for the duration of the study (March, 2014 - May, 2014). This analysis group includes all participants/eyes exposed to the study products. Trial-fit lenses were not considered study products.
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 investigational medical device.
|
Additional Information
Clinical Lead, Vision Care Development
Alcon Research, Ltd.
Phone: 1-888-451-3937
Email: [email protected]
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