Trial Outcomes & Findings for Bilateral Dispensing Study of MyDay Toric, 1-day Acuvue Moist for Astigmatism, and Dailies Aquacomfort Plus Toric Lenses (NCT NCT03134248)
NCT ID: NCT03134248
Last Updated: 2019-09-12
Results Overview
Subjective ratings of lens performance for comfort assessed. Comfort Scale 0-10, 0=painful, 10=can't feel the lenses.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
1 week
Results posted on
2019-09-12
Participant Flow
60 subjects were enrolled for this study (assigned a subjectID), but 11 of these subjects were screen failures, leaving 49 subjects who were randomized for lens assignments.
Participant milestones
| Measure |
1-Day AM First, Then DACP, Then MDT
1-day Acuvue Moist for Astig first, then Dailies Aquacomfort Plus, then MyDay Troic
|
1-Day AM First, Then MDT, Then DACP
1-day Acuvue Moist for Astig, then MyDay Toric, then Dailies Aquacomfort Plus
|
DACP First, Then 1-Day AM, Then MDT
Dailies Aquacomfort Plus, then 1-day Acuvue Moist for Astig, then MyDay Toric
|
DACP First, Then MDT, Then 1-Day AM
Dailies Aquacomfort Plus, then MyDay Toric, then 1-day Acuvue Moist for Astig
|
MDT First, Then 1-Day AM, Then DACP
MyDay Toric, then 1-day Acuvue Moist for Astig, then Dailies Aquacomfort Plus
|
MDT First, Then DACP, Then 1-Day AM
MyDay Toric, then Dailies Aquacomfort Plus, then 1-day Acuvue Moist for Astig
|
|---|---|---|---|---|---|---|
|
Week 1
STARTED
|
7
|
8
|
9
|
7
|
9
|
9
|
|
Week 1
COMPLETED
|
7
|
8
|
9
|
7
|
9
|
9
|
|
Week 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Week 2
STARTED
|
7
|
8
|
9
|
7
|
9
|
9
|
|
Week 2
COMPLETED
|
7
|
8
|
9
|
7
|
9
|
9
|
|
Week 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Week 3
STARTED
|
7
|
8
|
9
|
7
|
9
|
9
|
|
Week 3
COMPLETED
|
7
|
8
|
9
|
7
|
9
|
9
|
|
Week 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Study Participants
n=49 Participants
A bilateral dispensing of MyDay Toric, 1-Day Acuvue Moist for Astigmatism, and Dailies Aqua Comfort Plus Toric Contact Lenses
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=49 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
49 Participants
n=49 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=49 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=49 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=49 Participants
|
|
Region of Enrollment
Canada
|
49 Participants
n=49 Participants
|
PRIMARY outcome
Timeframe: 1 weekSubjective ratings of lens performance for comfort assessed. Comfort Scale 0-10, 0=painful, 10=can't feel the lenses.
Outcome measures
| Measure |
MyDay Toric Contact Lens
n=49 Participants
Participants randomly assigned to wear MyDay Toric lenses either as first, second or third lens in this crossover study.
|
1-Day Acuvue Moist for Astigmatism Contact Lens
n=49 Participants
Participants randomly assigned to wear 1-Day Acuvue Moist for Astigmatism contact lenses either as first, second or third lens in this crossover study.
|
Dailies Aquacomfort Plus Toric Contact Lens
n=49 Participants
Participants randomly assigned to wear Dailies Aquacomfort Plus Toric lenses either as first, second or third lens in this crossover study.
|
|---|---|---|---|
|
Comfort
|
8 units on a scale
Standard Deviation 1.37
|
9 units on a scale
Standard Deviation 1.14
|
8 units on a scale
Standard Deviation 2.05
|
PRIMARY outcome
Timeframe: 1 weekSubjective ratings of lens performance for dryness assessed. Dryness Scale 0-10, 0=extremely dry, 10=no dryness
Outcome measures
| Measure |
MyDay Toric Contact Lens
n=49 Participants
Participants randomly assigned to wear MyDay Toric lenses either as first, second or third lens in this crossover study.
|
1-Day Acuvue Moist for Astigmatism Contact Lens
n=49 Participants
Participants randomly assigned to wear 1-Day Acuvue Moist for Astigmatism contact lenses either as first, second or third lens in this crossover study.
|
Dailies Aquacomfort Plus Toric Contact Lens
n=49 Participants
Participants randomly assigned to wear Dailies Aquacomfort Plus Toric lenses either as first, second or third lens in this crossover study.
|
|---|---|---|---|
|
Dryness
|
9 units on a scale
Standard Deviation 1.69
|
8 units on a scale
Standard Deviation 1.65
|
7 units on a scale
Standard Deviation 2.18
|
PRIMARY outcome
Timeframe: 1 weekSubjective ratings of lens performance for visual quality assessed. Visual quality Scale 0-10, 0=completely dissatisfied, 10=completely satisfied
Outcome measures
| Measure |
MyDay Toric Contact Lens
n=49 Participants
Participants randomly assigned to wear MyDay Toric lenses either as first, second or third lens in this crossover study.
|
1-Day Acuvue Moist for Astigmatism Contact Lens
n=49 Participants
Participants randomly assigned to wear 1-Day Acuvue Moist for Astigmatism contact lenses either as first, second or third lens in this crossover study.
|
Dailies Aquacomfort Plus Toric Contact Lens
n=49 Participants
Participants randomly assigned to wear Dailies Aquacomfort Plus Toric lenses either as first, second or third lens in this crossover study.
|
|---|---|---|---|
|
Visual Quality
|
9 units on a scale
Standard Deviation 1.41
|
8 units on a scale
Standard Deviation 1.14
|
8 units on a scale
Standard Deviation 1.81
|
PRIMARY outcome
Timeframe: 1 weekOverall comfort preference of MyDay Toric, 1-Day Acuvue Moist Toric or Dailies Aquacomfort Plus Toric lenses. Scale: Strong or Slight preference for one lens, or No-preference
Outcome measures
| Measure |
MyDay Toric Contact Lens
n=49 Participants
Participants randomly assigned to wear MyDay Toric lenses either as first, second or third lens in this crossover study.
|
1-Day Acuvue Moist for Astigmatism Contact Lens
Participants randomly assigned to wear 1-Day Acuvue Moist for Astigmatism contact lenses either as first, second or third lens in this crossover study.
|
Dailies Aquacomfort Plus Toric Contact Lens
Participants randomly assigned to wear Dailies Aquacomfort Plus Toric lenses either as first, second or third lens in this crossover study.
|
|---|---|---|---|
|
Lens Preference With Respect to Overall Comfort
Strongly Prefer MyDay Toric
|
15 Participants
|
—
|
—
|
|
Lens Preference With Respect to Overall Comfort
Slightly Prefer MyDay Toric
|
6 Participants
|
—
|
—
|
|
Lens Preference With Respect to Overall Comfort
Strongly Prefer 1Day Acuvue Moist Toric
|
14 Participants
|
—
|
—
|
|
Lens Preference With Respect to Overall Comfort
Slightly Prefer 1Day Acuvue Moist Toric
|
5 Participants
|
—
|
—
|
|
Lens Preference With Respect to Overall Comfort
Strongly Prefer Dailies Aquacomfort Plus Toric
|
5 Participants
|
—
|
—
|
|
Lens Preference With Respect to Overall Comfort
Slighlty Prefer Dailies Aquacomfort Plus Toric
|
3 Participants
|
—
|
—
|
|
Lens Preference With Respect to Overall Comfort
No Preference
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 weekOverall visual quality preference of MyDay Toric, 1-Day Acuvue Moist Toric or Dailies Aquacomfort Plus Toric lenses. Scale: Strong or Slight preference for one lens, or No-preference
Outcome measures
| Measure |
MyDay Toric Contact Lens
n=49 Participants
Participants randomly assigned to wear MyDay Toric lenses either as first, second or third lens in this crossover study.
|
1-Day Acuvue Moist for Astigmatism Contact Lens
Participants randomly assigned to wear 1-Day Acuvue Moist for Astigmatism contact lenses either as first, second or third lens in this crossover study.
|
Dailies Aquacomfort Plus Toric Contact Lens
Participants randomly assigned to wear Dailies Aquacomfort Plus Toric lenses either as first, second or third lens in this crossover study.
|
|---|---|---|---|
|
Lens Preference With Respect to Visual Quality
Slightly Prefer MyDay Toric
|
4 Participants
|
—
|
—
|
|
Lens Preference With Respect to Visual Quality
Strongly Prefer 1Day Acuvue Moist Toric
|
9 Participants
|
—
|
—
|
|
Lens Preference With Respect to Visual Quality
Strongly Prefer MyDay Toric
|
10 Participants
|
—
|
—
|
|
Lens Preference With Respect to Visual Quality
Slightly Prefer 1Day Acuvue Moist Toric
|
8 Participants
|
—
|
—
|
|
Lens Preference With Respect to Visual Quality
Strongly Prefer Dailies Aquacomfort Plus Toric
|
6 Participants
|
—
|
—
|
|
Lens Preference With Respect to Visual Quality
Slightly Prefer Dailies Aquacomfort Plus Toric
|
2 Participants
|
—
|
—
|
|
Lens Preference With Respect to Visual Quality
No Preference
|
10 Participants
|
—
|
—
|
Adverse Events
MyDay Toric
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
1-Day Acuvue Moist for Astigmatism
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dailies Aqua Comfort Plus Toric
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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 Disclosure restriction on the PI is that the sponsor should be notified of any results communications and has ability to review.
- Publication restrictions are in place
Restriction type: OTHER