ACUVUE® OASYS® 1-DAY vs DAILIES TOTAL1®
Study Details
Study Description
Brief Summary
The purpose of this study is to compare the lens fit characteristics, specifically lens centration, of ACUVUE® OASYS® 1-DAY (AO1D) contact lenses and DAILIES TOTAL1® (DT1) contact lenses.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Other: DT1, then AO1D Delefilcon A contact lenses worn first, followed by senofilcon A contact lenses. Each product worn bilaterally (in both eyes) for 14 days in a daily wear, daily disposable modality. |
Device: Delefilcon A contact lenses
Other Names:
Device: Senofilcon A contact lenses
Other Names:
|
Other: AO1D, then DT1 Senofilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product worn bilaterally for 14 days in a daily wear, daily disposable modality. |
Device: Delefilcon A contact lenses
Other Names:
Device: Senofilcon A contact lenses
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Lenses Graded as 0 or 1 for Lens Centration at Day 14 [Day 14, each product]
Lens centration, was assessed by the investigator for each eye individually and rated on a 5-point scale: 0=centered/optimal, 1=slight decentration, 2=mild decentration, 3=moderate decentration, 4=severe decentration. The combined percentage of lenses assessed as "centered" or "slight decentration" is reported. Lenses from both eyes contributed to the percentage.
Secondary Outcome Measures
- Ex Vivo Critical Coefficient of Friction (CCOF) at Day 14 [Day 14, each product]
The ex vivo CCOF (ratio of the force of friction between two bodies and the force pressing them together) was measured by the incline plane technique after 16 hours of lens wear. Worn lenses were collected and analyzed for a subset of subjects (all subjects from one site only) who attended the Day 14 visit (Visit 2 and Visit 3) after 16 hours of lens wear. Only lens worn on the right eye (OD) was measured in each subject per each lens brand. CCOF values for contact lenses range from near zero to approximately 0.10 using the inclined plane method. A lower CCOF indicates higher contact lens lubricity.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Must sign informed consent form;
-
Adapted, current daily disposable soft contact lens wearer who typically wears lenses every day, or at least 5 days per week, 6 hours per day;
-
Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Pre-screening questionnaire;
-
Prescription within -1.00 Diopter (D) to -6.00D to be fitted with study contact lenses;
-
Cylinder equal or lower than -0.75D in both eyes;
-
Vision correctable to 20/25 or 0.1 logMAR (Logarithmic minimum angle of resolution) or better in each eye at distance with both study lenses at Visit 1;
-
Can be successfully fitted with both study lenses at Visit 1;
-
Willing to wear lenses every day or at least 5 days per week, 6 hours per day and attend all study visits;
-
Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
-
Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
-
Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the Investigator;
-
Monocular (only 1 eye with functional vision) or fit with only 1 lens;
-
Fitted with monovision;
-
Prior refractive surgery;
-
History of herpetic keratitis, ocular surgery, or irregular cornea;
-
Pregnant or lactating;
-
Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study;
-
Participation in any clinical study within 30 days of Visit 1;
-
Current DT1 or AO1D lens wearer;
-
Other protocol-specified exclusion criteria may apply.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Contact Alcon Call Center for Trial Locations | Fort Worth | Texas | United States | 76134 |
Sponsors and Collaborators
- Alcon, a Novartis Company
Investigators
- Study Director: Sr. Clinical Manager, Global Medical Affairs, GCRA, Alcon, A Novartis Division
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CLV771-P001
Study Results
Participant Flow
Recruitment Details | Subjects were recruited from 12 study centers located in the United States. |
---|---|
Pre-assignment Detail | Of the 252 enrolled, 5 subjects were exited prior to randomization and 1 randomized subject was exited prior to treatment. This reporting group includes all randomized subjects who were exposed to a study product (test or control) (246). |
Arm/Group Title | DT1, Then AO1D | AO1D, Then DT1 |
---|---|---|
Arm/Group Description | Delefilcon A contact lenses worn first, followed by senofilcon A contact lenses. Each product worn bilaterally (in both eyes) for 14 days in a daily wear, daily disposable modality. | Senofilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product worn bilaterally for 14 days in a daily wear, daily disposable modality. |
Period Title: Period 1, First 14 Days of Wear | ||
STARTED | 125 | 121 |
COMPLETED | 124 | 120 |
NOT COMPLETED | 1 | 1 |
Period Title: Period 1, First 14 Days of Wear | ||
STARTED | 124 | 120 |
COMPLETED | 124 | 120 |
NOT COMPLETED | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Overall |
---|---|
Arm/Group Description | Delefilcon A and senofilcon A contact lenses worn during Period 1 and Period 2 in a crossover assignment. |
Overall Participants | 246 |
Age (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] |
30.7
(8.44)
|
Sex: Female, Male (Count of Participants) | |
Female |
183
74.4%
|
Male |
63
25.6%
|
Outcome Measures
Title | Percentage of Lenses Graded as 0 or 1 for Lens Centration at Day 14 |
---|---|
Description | Lens centration, was assessed by the investigator for each eye individually and rated on a 5-point scale: 0=centered/optimal, 1=slight decentration, 2=mild decentration, 3=moderate decentration, 4=severe decentration. The combined percentage of lenses assessed as "centered" or "slight decentration" is reported. Lenses from both eyes contributed to the percentage. |
Time Frame | Day 14, each product |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set. Number Analyzed is the number of eyes with non-missing response. |
Arm/Group Title | DAILIES TOTAL1 | AO1D |
---|---|---|
Arm/Group Description | Delefilcon A contact lenses worn bilaterally for 14 days in a daily wear, daily disposable modality | Senofilcon A contact lenses worn bilaterally for 14 days in a daily wear, daily disposable modality |
Measure Participants | 244 | 244 |
Measure Eyes | 488 | 488 |
Number [percentage of lenses] |
100.0
|
99.4
|
Title | Ex Vivo Critical Coefficient of Friction (CCOF) at Day 14 |
---|---|
Description | The ex vivo CCOF (ratio of the force of friction between two bodies and the force pressing them together) was measured by the incline plane technique after 16 hours of lens wear. Worn lenses were collected and analyzed for a subset of subjects (all subjects from one site only) who attended the Day 14 visit (Visit 2 and Visit 3) after 16 hours of lens wear. Only lens worn on the right eye (OD) was measured in each subject per each lens brand. CCOF values for contact lenses range from near zero to approximately 0.10 using the inclined plane method. A lower CCOF indicates higher contact lens lubricity. |
Time Frame | Day 14, each product |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set. Number Analyzed is the number of eyes with non-missing responses, including only subjects from one site. |
Arm/Group Title | DAILIES TOTAL1 | AO1D |
---|---|---|
Arm/Group Description | Delefilcon A contact lenses worn bilaterally for 14 days in a daily wear, daily disposable modality | Senofilcon A contact lenses worn bilaterally for 14 days in a daily wear, daily disposable modality |
Measure Participants | 17 | 17 |
Measure Eyes | 17 | 17 |
Mean (Standard Deviation) [unitless] |
0.0468
(0.00557)
|
0.0675
(0.00599)
|
Adverse Events
Time Frame | Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pre-treatment and treatment-emergent. | |||||
---|---|---|---|---|---|---|
Adverse Event Reporting Description | An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device. | |||||
Arm/Group Title | Pretreatment | DAILIES TOTAL1 (DT1) | ACUVUE OASYS 1-DAY (AO1D) | |||
Arm/Group Description | All subjects who consented to participate in the study prior to initiation of study treatment | All subjects exposed to DT1 contact lenses, except for lenses used for parameter optimization and fitting | All subjects exposed to AO1D contact lenses, except for lenses used for parameter optimization and fitting | |||
All Cause Mortality |
||||||
Pretreatment | DAILIES TOTAL1 (DT1) | ACUVUE OASYS 1-DAY (AO1D) | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/252 (0%) | 0/246 (0%) | 0/246 (0%) | |||
Serious Adverse Events |
||||||
Pretreatment | DAILIES TOTAL1 (DT1) | ACUVUE OASYS 1-DAY (AO1D) | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/252 (0%) | 0/246 (0%) | 0/246 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
Pretreatment | DAILIES TOTAL1 (DT1) | ACUVUE OASYS 1-DAY (AO1D) | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/252 (0%) | 0/246 (0%) | 0/246 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
Name/Title | Franchise Head, Vision Care |
---|---|
Organization | Alcon, A Novartis Division |
Phone | 1-888-451-3937 |
alcon.medinfo@alcon.com |
- CLV771-P001