Trial Outcomes & Findings for DAILIES TOTAL1 Versus ACUVUE TruEye - Effects on the Biology of the Ocular Surface and Lid Margin (NCT NCT02347631)
NCT ID: NCT02347631
Last Updated: 2020-12-10
Results Overview
Group 1: Rate of desquamation of corneal epithelial cells (cells/min) will be assessed for participants wearing Alcon DAILIES contacts lenses. 1. Initial 1 mo. washout period (baseline 1). 2. Participant wears the Alcon DAILIES contacts for 2 months after baseline 1. Group 2: Rate of desquamation of corneal epithelial cells (cells/min) will be assessed for participants wearing AcuVue TRUEYE contact lenses. 1. Second 1 mo. washout period (baseline 2). 2. Participant wears the Acuvue TRUEYE contacts for 2 months after baseline 2.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
118 participants
Primary outcome timeframe
Baseline + 3 months
Results posted on
2020-12-10
Participant Flow
Patients were screened for eligibility in 2017 at the Aston Ambulatory Optometry Clinic at UT Southwestern Medical Center.
118 patients were randomize for the study. This is a crossover to compare patients who wear DAILIES contact lenses first, then TruEye contact lenses, vs. patients who wear TruEye contacts first, them DAILIES contact lenses second.
Participant milestones
| Measure |
Alcon DAILIES TOTAL1, Then ACUVUE TRUEYE Contact Lenses
Comparison of Alcon Dailies Total 1 versus Acuvue TruEye when worn as daily disposables over a two month period. This is a crossover project where both lenses will be worn by participant over the course of the study. The order of randomization will differ for each participant.
Intervention 1: Soft Contact Lens - Daily Disposable Name - Alcon Dailies Total 1 Material - Delefilcon A Water Content - 33% Oxygen Permeability - 140 x10-11 (cm2/sec)(mL O2/mL mmHg) Oxygen Transmissibility - 156 x10-9 (cm/sec)(mL O2/mL mmHg) Base Curve - 8.5mm Manner of Wear - Daily Disposables Wearing Time - 2 months
Washout period - 1 month
Intervention 2: Soft Contact Lens - Daily Disposable Name - Acuvue TruEye Material - Narafilcon A Water Content - 46% Oxygen Permeability - 100 x10-11 (cm2/sec)(mL O2/mL mmHg) Oxygen Transmissibility - 118 x10-9 (cm/sec)(mL O2/mL mmHg) Base Curve - 8.5mm \& 9.0mm Manner of Wear - Daily Disposables Wearing Time - 2 months
|
ACUVUE TRUEYE, Then Alcon DAILIES TOTAL1 Contact Lenses
Comparison of Acuvue TruEye versus Alcon Dailies Total 1 contact lenses when worn as daily disposables over a two month period. This is a crossover project where both lenses will be worn by participant over the course of the study. The order of randomization will differ for each participant.
Intervention 1: Soft Contact Lens - Daily Disposable Name - Acuvue TruEye Material - Narafilcon A Water Content - 46% Oxygen Permeability - 100 x10-11 (cm2/sec)(mL O2/mL mmHg) Oxygen Transmissibility - 118 x10-9 (cm/sec)(mL O2/mL mmHg) Base Curve - 8.5mm \& 9.0mm Manner of Wear - Daily Disposables Wearing Time - 2 months
Washout period - 1 month
Intervention 2 : Soft Contact Lens - Daily Disposable Name - Alcon Dailies Total 1 Material - Delefilcon A Water Content - 33% Oxygen Permeability - 140 x10-11 (cm2/sec)(mL O2/mL mmHg) Oxygen Transmissibility - 156 x10-9 (cm/sec)(mL O2/mL mmHg) Base Curve - 8.5mm Manner of Wear - Daily Disposables Wearing Time - 2 months
|
|---|---|---|
|
Washout 1 (1 Month)
STARTED
|
61
|
57
|
|
Washout 1 (1 Month)
COMPLETED
|
61
|
57
|
|
Washout 1 (1 Month)
NOT COMPLETED
|
0
|
0
|
|
First Intervention (2 Months)
STARTED
|
61
|
57
|
|
First Intervention (2 Months)
COMPLETED
|
54
|
51
|
|
First Intervention (2 Months)
NOT COMPLETED
|
7
|
6
|
|
Washout 2 (1 Month)
STARTED
|
54
|
51
|
|
Washout 2 (1 Month)
COMPLETED
|
52
|
48
|
|
Washout 2 (1 Month)
NOT COMPLETED
|
2
|
3
|
|
Second Intervention (2 Months)
STARTED
|
52
|
48
|
|
Second Intervention (2 Months)
COMPLETED
|
39
|
44
|
|
Second Intervention (2 Months)
NOT COMPLETED
|
13
|
4
|
Reasons for withdrawal
| Measure |
Alcon DAILIES TOTAL1, Then ACUVUE TRUEYE Contact Lenses
Comparison of Alcon Dailies Total 1 versus Acuvue TruEye when worn as daily disposables over a two month period. This is a crossover project where both lenses will be worn by participant over the course of the study. The order of randomization will differ for each participant.
Intervention 1: Soft Contact Lens - Daily Disposable Name - Alcon Dailies Total 1 Material - Delefilcon A Water Content - 33% Oxygen Permeability - 140 x10-11 (cm2/sec)(mL O2/mL mmHg) Oxygen Transmissibility - 156 x10-9 (cm/sec)(mL O2/mL mmHg) Base Curve - 8.5mm Manner of Wear - Daily Disposables Wearing Time - 2 months
Washout period - 1 month
Intervention 2: Soft Contact Lens - Daily Disposable Name - Acuvue TruEye Material - Narafilcon A Water Content - 46% Oxygen Permeability - 100 x10-11 (cm2/sec)(mL O2/mL mmHg) Oxygen Transmissibility - 118 x10-9 (cm/sec)(mL O2/mL mmHg) Base Curve - 8.5mm \& 9.0mm Manner of Wear - Daily Disposables Wearing Time - 2 months
|
ACUVUE TRUEYE, Then Alcon DAILIES TOTAL1 Contact Lenses
Comparison of Acuvue TruEye versus Alcon Dailies Total 1 contact lenses when worn as daily disposables over a two month period. This is a crossover project where both lenses will be worn by participant over the course of the study. The order of randomization will differ for each participant.
Intervention 1: Soft Contact Lens - Daily Disposable Name - Acuvue TruEye Material - Narafilcon A Water Content - 46% Oxygen Permeability - 100 x10-11 (cm2/sec)(mL O2/mL mmHg) Oxygen Transmissibility - 118 x10-9 (cm/sec)(mL O2/mL mmHg) Base Curve - 8.5mm \& 9.0mm Manner of Wear - Daily Disposables Wearing Time - 2 months
Washout period - 1 month
Intervention 2 : Soft Contact Lens - Daily Disposable Name - Alcon Dailies Total 1 Material - Delefilcon A Water Content - 33% Oxygen Permeability - 140 x10-11 (cm2/sec)(mL O2/mL mmHg) Oxygen Transmissibility - 156 x10-9 (cm/sec)(mL O2/mL mmHg) Base Curve - 8.5mm Manner of Wear - Daily Disposables Wearing Time - 2 months
|
|---|---|---|
|
First Intervention (2 Months)
Adverse Event
|
1
|
1
|
|
First Intervention (2 Months)
Pregnancy
|
1
|
0
|
|
First Intervention (2 Months)
Moved out of area
|
0
|
2
|
|
First Intervention (2 Months)
Lost to Follow-up
|
5
|
3
|
|
Washout 2 (1 Month)
Withdrawal by Subject
|
2
|
2
|
|
Washout 2 (1 Month)
Lost to Follow-up
|
0
|
1
|
|
Second Intervention (2 Months)
Lost to Follow-up
|
7
|
4
|
|
Second Intervention (2 Months)
Withdrawal by Subject
|
6
|
0
|
Baseline Characteristics
DAILIES TOTAL1 Versus ACUVUE TruEye - Effects on the Biology of the Ocular Surface and Lid Margin
Baseline characteristics by cohort
| Measure |
Alcon DAILIES TOTAL1, and ACUVUE TRUEYE Contact Lenses
n=61 Participants
Comparison of Alcon Dailies Total 1 versus Acuvue TruEye when worn as daily disposables over a two month period. This is a crossover project where both lenses will be worn by participant over the course of the study. The order of randomization will differ for each participant.
Intervention 1: Soft Contact Lens - Daily Disposable Name - Alcon Dailies Total 1 Material - Delefilcon A Water Content - 33% Oxygen Permeability - 140 x10-11 (cm2/sec)(mL O2/mL mmHg) Oxygen Transmissibility - 156 x10-9 (cm/sec)(mL O2/mL mmHg) Base Curve - 8.5mm Manner of Wear - Daily Disposables Wearing Time - 2 months
Washout period - 1 month
Intervention 2: Soft Contact Lens - Daily Disposable Name - Acuvue TruEye Material - Narafilcon A Water Content - 46% Oxygen Permeability - 100 x10-11 (cm2/sec)(mL O2/mL mmHg) Oxygen Transmissibility - 118 x10-9 (cm/sec)(mL O2/mL mmHg) Base Curve - 8.5mm \& 9.0mm Manner of Wear - Daily Disposables Wearing Time - 2 months
|
ACUVUE TRUEYE, and Alcon DAILIES TOTAL1 Contact Lenses
n=57 Participants
Comparison of Acuvue TruEye versus Alcon Dailies Total 1 contact lenses when worn as daily disposables over a two month period. This is a crossover project where both lenses will be worn by participant over the course of the study. The order of randomization will differ for each participant.
Intervention 1: Soft Contact Lens - Daily Disposable Name - Acuvue TruEye Material - Narafilcon A Water Content - 46% Oxygen Permeability - 100 x10-11 (cm2/sec)(mL O2/mL mmHg) Oxygen Transmissibility - 118 x10-9 (cm/sec)(mL O2/mL mmHg) Base Curve - 8.5mm \& 9.0mm Manner of Wear - Daily Disposables Wearing Time - 2 months
Washout period - 1 month
Intervention 2 : Soft Contact Lens - Daily Disposable Name - Alcon Dailies Total 1 Material - Delefilcon A Water Content - 33% Oxygen Permeability - 140 x10-11 (cm2/sec)(mL O2/mL mmHg) Oxygen Transmissibility - 156 x10-9 (cm/sec)(mL O2/mL mmHg) Base Curve - 8.5mm Manner of Wear - Daily Disposables Wearing Time - 2 months
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
61 Participants
n=93 Participants
|
57 Participants
n=4 Participants
|
118 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
81 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
37 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
51 Participants
n=93 Participants
|
46 Participants
n=4 Participants
|
97 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
20 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
37 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
54 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Desquamation rate
|
76.98 cells/min
STANDARD_DEVIATION 21.97 • n=93 Participants
|
79.26 cells/min
STANDARD_DEVIATION 20.88 • n=4 Participants
|
78.72 cells/min
STANDARD_DEVIATION 21.32 • n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline + 3 monthsPopulation: All participants completed a 1 mo. washout 1 and wore the 1st set of contact lenses (Alcon DAILIES), then completed a second 1 mo. washout, and wore a 2nd set of contact lenses (Acuvue TRUEYE).
Group 1: Rate of desquamation of corneal epithelial cells (cells/min) will be assessed for participants wearing Alcon DAILIES contacts lenses. 1. Initial 1 mo. washout period (baseline 1). 2. Participant wears the Alcon DAILIES contacts for 2 months after baseline 1. Group 2: Rate of desquamation of corneal epithelial cells (cells/min) will be assessed for participants wearing AcuVue TRUEYE contact lenses. 1. Second 1 mo. washout period (baseline 2). 2. Participant wears the Acuvue TRUEYE contacts for 2 months after baseline 2.
Outcome measures
| Measure |
Alcon DAILIES TOTAL1 Contact Lenses
n=39 Participants
A 1 month washout will precede the intervention.
Intervention: Soft Contact Lens - Daily Disposable Name - Alcon Dailies Total 1 Material - Delefilcon A Water Content - 33% Oxygen Permeability - 140 x10-11 (cm2/sec)(mL O2/mL mmHg) Oxygen Transmissibility - 156 x10-9 (cm/sec)(mL O2/mL mmHg) Base Curve - 8.5mm Manner of Wear - Daily Disposables Wearing Time - 2 months
|
ACUVUE TRUEYE Contact Lenses
n=39 Participants
A 1 month washout will precede the intervention.
Intervention: Soft Contact Lens - Daily Disposable Name - Acuvue TruEye Material - Narafilcon A Water Content - 46% Oxygen Permeability - 100 x10-11 (cm2/sec)(mL O2/mL mmHg) Oxygen Transmissibility - 118 x10-9 (cm/sec)(mL O2/mL mmHg) Base Curve - 8.5mm \& 9.0mm Manner of Wear - Daily Disposables Wearing Time - 2 months
|
|---|---|---|
|
Desquamation Rate of Wearing Alcon DAILIES, Then AcuVue TruEye Contact Lenses
|
53.86 cells/min
Standard Deviation 13.00
|
54.05 cells/min
Standard Deviation 11.91
|
PRIMARY outcome
Timeframe: Baseline + 3 monthsPopulation: All participants completed a 1 mo. washout 1 and wore the 1st set of contact lenses (Acuvue TRUEYE), then completed a second 1 mo. washout, and wore a 2nd set of contact lenses (Alcon DAILIES).
Group 1: Rate of desquamation of corneal epithelial cells (cells/min) will be assessed for participants wearing Acuvue TRUEYE contacts lenses. 1. Initial 1 mo. washout period (baseline 1). 2. Participant wears the Acuvue TRUEYE contacts for 2 months after baseline 1. Group 2: Rate of desquamation of corneal epithelial cells (cells/min) will be assessed for participants wearing Alcon DAILIES contact lenses. 1. Second 1 mo. washout period (baseline 2). 2. Participant wears the Alcon DAILIES contacts for 2 months after baseline 2.
Outcome measures
| Measure |
Alcon DAILIES TOTAL1 Contact Lenses
n=44 Participants
A 1 month washout will precede the intervention.
Intervention: Soft Contact Lens - Daily Disposable Name - Alcon Dailies Total 1 Material - Delefilcon A Water Content - 33% Oxygen Permeability - 140 x10-11 (cm2/sec)(mL O2/mL mmHg) Oxygen Transmissibility - 156 x10-9 (cm/sec)(mL O2/mL mmHg) Base Curve - 8.5mm Manner of Wear - Daily Disposables Wearing Time - 2 months
|
ACUVUE TRUEYE Contact Lenses
n=44 Participants
A 1 month washout will precede the intervention.
Intervention: Soft Contact Lens - Daily Disposable Name - Acuvue TruEye Material - Narafilcon A Water Content - 46% Oxygen Permeability - 100 x10-11 (cm2/sec)(mL O2/mL mmHg) Oxygen Transmissibility - 118 x10-9 (cm/sec)(mL O2/mL mmHg) Base Curve - 8.5mm \& 9.0mm Manner of Wear - Daily Disposables Wearing Time - 2 months
|
|---|---|---|
|
Desquamation Rate of Wearing Acuvue TruEye, Then Alcon DAILIES Contact Lenses
|
53.48 cells/min.
Standard Deviation 13.10
|
54.19 cells/min.
Standard Deviation 12.34
|
Adverse Events
Alcon DAILIES TOTAL1 Contact Lenses
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
ACUVUE TRUEYE Contact Lenses
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Alcon DAILIES TOTAL1 Contact Lenses
n=118 participants at risk
A 1 month washout will precede the intervention.
Intervention: Soft Contact Lens - Daily Disposable Name - Alcon Dailies Total 1 Material - Delefilcon A Water Content - 33% Oxygen Permeability - 140 x10-11 (cm2/sec)(mL O2/mL mmHg) Oxygen Transmissibility - 156 x10-9 (cm/sec)(mL O2/mL mmHg) Base Curve - 8.5mm Manner of Wear - Daily Disposables Wearing Time - 2 months
|
ACUVUE TRUEYE Contact Lenses
n=118 participants at risk
A 1 month washout will precede the intervention.
Intervention: Soft Contact Lens - Daily Disposable Name - Acuvue TruEye Material - Narafilcon A Water Content - 46% Oxygen Permeability - 100 x10-11 (cm2/sec)(mL O2/mL mmHg) Oxygen Transmissibility - 118 x10-9 (cm/sec)(mL O2/mL mmHg) Base Curve - 8.5mm \& 9.0mm Manner of Wear - Daily Disposables Wearing Time - 2 months
|
|---|---|---|
|
Eye disorders
Corneal Ulcer
|
0.85%
1/118 • Number of events 1 • Baseline + 6 months
|
0.00%
0/118 • Baseline + 6 months
|
|
Eye disorders
Bacterial Conjunctivitis
|
0.85%
1/118 • Number of events 1 • Baseline + 6 months
|
0.00%
0/118 • Baseline + 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place