Trial Outcomes & Findings for Visual Assessment of DAILIES® AquaComfort Plus® for Astigmatism as Compared to 1-DAY ACUVUE® MOIST® for Astigmatism (NCT NCT02071771)
NCT ID: NCT02071771
Last Updated: 2015-11-10
Results Overview
TCVA test was performed at 4 meters under high illumination (90%) using a Landolt ring test. For each acuity level, a series of single rings with gaps in one of four directions was presented and the percentage of correctly identified rings constituted the score. TCVA was measured in VA units and a higher TCVA value indicates an improvement in visual acuity. Both eyes contributed to the analysis.
COMPLETED
NA
80 participants
Day 10, each product
2015-11-10
Participant Flow
Subjects were recruited from 1 study center located in the US and 1 study center located in the UK.
This reporting group includes all enrolled participants, as treated. Note: 2 participants randomized to DACP T were exited prior to dispense due to unacceptable fit (1) and unavailable lens power (1).
Participant milestones
| Measure |
DACP T, Then 1DAM A
Nelfilcon A toric contact lenses worn first, with Etafilcon A toric contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 10 days.
|
1DAM A, Then DACP T
Etafilcon A toric contact lenses worn first, with Nelfilcon A toric contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 10 days.
|
|---|---|---|
|
Period 1: First 10 Days
STARTED
|
41
|
39
|
|
Period 1: First 10 Days
Dispensed
|
39
|
39
|
|
Period 1: First 10 Days
COMPLETED
|
39
|
39
|
|
Period 1: First 10 Days
NOT COMPLETED
|
2
|
0
|
|
Period 2: Second 10 Days
STARTED
|
39
|
38
|
|
Period 2: Second 10 Days
COMPLETED
|
39
|
38
|
|
Period 2: Second 10 Days
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
DACP T, Then 1DAM A
Nelfilcon A toric contact lenses worn first, with Etafilcon A toric contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 10 days.
|
1DAM A, Then DACP T
Etafilcon A toric contact lenses worn first, with Nelfilcon A toric contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 10 days.
|
|---|---|---|
|
Period 1: First 10 Days
Unacceptable lens fit
|
1
|
0
|
|
Period 1: First 10 Days
Unavailable lens power
|
1
|
0
|
Baseline Characteristics
Visual Assessment of DAILIES® AquaComfort Plus® for Astigmatism as Compared to 1-DAY ACUVUE® MOIST® for Astigmatism
Baseline characteristics by cohort
| Measure |
Overall
n=69 Participants
Nelfilcon A and Etafilcon A toric contact lenses worn during Period 1 and Period 2, as randomized, in a crossover assignment.
|
|---|---|
|
Age, Continuous
|
32.9 years
STANDARD_DEVIATION 9.4 • n=99 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Day 10, each productPopulation: This analysis group includes all randomized subjects who had no major protocol violations excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan.
TCVA test was performed at 4 meters under high illumination (90%) using a Landolt ring test. For each acuity level, a series of single rings with gaps in one of four directions was presented and the percentage of correctly identified rings constituted the score. TCVA was measured in VA units and a higher TCVA value indicates an improvement in visual acuity. Both eyes contributed to the analysis.
Outcome measures
| Measure |
DACP T
n=69 Participants
Nelfilcon A toric contact lenses worn bilaterally during Period 1 or Period 2 on a daily wear, daily disposable basis for 10 days.
|
1DAM A
n=69 Participants
Etafilcon A toric contact lenses worn bilaterally during Period 1 or Period 2 on a daily wear, daily disposable basis for 10 days.
|
|---|---|---|
|
High Contrast Time Controlled Visual Acuity (TCVA) at Day 10
|
0.02 VA units
Standard Deviation 0.94
|
0.04 VA units
Standard Deviation 0.92
|
SECONDARY outcome
Timeframe: Day 10, each productPopulation: This analysis group includes all randomized subjects at the UK site with data at visit who had no major protocol violations excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan.
Lens oscillation (rotational stability of the lens on the eye) at blink was video-recorded. Digital images were used to measure the rotational characteristics of the lenses and objectively measure the amplitude of the lens oscillation. A higher value indicates greater lens movement on the eye. This outcome measure was collected at one site only.
Outcome measures
| Measure |
DACP T
n=38 Participants
Nelfilcon A toric contact lenses worn bilaterally during Period 1 or Period 2 on a daily wear, daily disposable basis for 10 days.
|
1DAM A
n=38 Participants
Etafilcon A toric contact lenses worn bilaterally during Period 1 or Period 2 on a daily wear, daily disposable basis for 10 days.
|
|---|---|---|
|
Lens Oscillation at Blink at Day 10
Right Eye
|
2.1 degrees
Standard Deviation 1.0
|
2.7 degrees
Standard Deviation 1.1
|
|
Lens Oscillation at Blink at Day 10
Left Eye
|
2.1 degrees
Standard Deviation 1.0
|
2.5 degrees
Standard Deviation 0.8
|
Adverse Events
DACP T
1DAM A
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sr Global Brand Lead, GCRA, Vision Care
Alcon Research, Ltd.
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