Clinical Comparison of 4 Daily Disposable Soft Contact Lenses
Study Details
Study Description
Brief Summary
The purpose of this study is to obtain on-eye performance data to inform contact lens product development and to further evaluate product performance in the intended population.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
The expected duration of subject participation in the study is approximately 20 days with 3 scheduled visits. Each subject will evaluate the test contact lenses compared to 1 of 3 commercially available contact lenses.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Other: DD T2/Oasys 1-Day Verofilcon A contact lenses and senofilcon A contact lenses worn in both eyes, each product, for 1 week on a daily wear basis, as randomized |
Device: verofilcon A contact lenses
Investigational spherical silicone hydrogel contact lenses for daily disposable wear
Other Names:
Device: senofilcon A contact lenses
Commercially available spherical silicone hydrogel contact lenses for daily disposable wear
Other Names:
|
Other: DD T2/MyDay Verofilcon A contact lenses and stenfilcon A contact lenses worn in both eyes, each product, for 1 week on a daily disposable basis, as randomized |
Device: verofilcon A contact lenses
Investigational spherical silicone hydrogel contact lenses for daily disposable wear
Other Names:
Device: stenfilcon A contact lenses
Commercially available spherical silicone hydrogel contact lenses for daily disposable wear
Other Names:
|
Other: DD T2/Moist Verofilcon A contact lenses and etafilcon A contact lenses worn in both eyes, each product, for 1 week on a daily disposable basis, as randomized |
Device: verofilcon A contact lenses
Investigational spherical silicone hydrogel contact lenses for daily disposable wear
Other Names:
Device: etafilcon A contact lenses
Commercially available spherical silicone hydrogel contact lenses for daily disposable wear
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Overall Quality of Vision [Day 8, each product]
Overall quality of vision was collected binocularly and rated on a 10-point scale with 1 = poor to 10 = excellent. Subjects were asked "Thinking back over the last week, please rate our study lenses. Rate eyes together." No formal hypotheses was conducted; hence no inferential testing was performed.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Able to understand and must sign an approved Informed Consent Form
-
Successfully wears daily disposable spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months
-
Best Corrected Visual Acuity of 20/25 Snellen or better in each eye
-
Willing to stop wearing habitual contact lenses for the duration of study participation
-
Other protocol-defined inclusion criteria may apply
Exclusion Criteria:
-
Any eye condition, surgery, disease, or use of medication that contraindicates contact lens wear, as determined by the Investigator.
-
Routinely sleeps in habitual contact lenses
-
Currently wears Oasys 1-Day, MyDay, or Moist contact lenses
-
Other protocol-defined exclusion criteria may apply
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Alcon Investigative Site | Maitland | Florida | United States | 32751 |
2 | Alcon Investigative Site | Pensacola | Florida | United States | 32503 |
3 | Alcon Investigative Site | Johns Creek | Georgia | United States | 30097 |
Sponsors and Collaborators
- Alcon Research
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- CLE383-C004
Study Results
Participant Flow
Recruitment Details | Subjects were recruited from 3 investigational sites located in the United States. |
---|---|
Pre-assignment Detail | Of the 68 enrolled, 2 subjects exited as screen failures prior to randomization. This reporting group includes all randomized subjects (66). |
Arm/Group Title | DD T2/Oasys 1-Day (Sequence 1) | Oasys 1-Day/DD T2 (Sequence 2) | DD T2/MyDay (Sequence 3) | MyDay/DD T2 (Sequence 4) | DD T2/Moist (Sequence 5) | Moist/DD T2 (Sequence 6) |
---|---|---|---|---|---|---|
Arm/Group Description | Verofilcon A contact lenses worn in Period 1, followed by senofilcon A contact lenses worn in Period 2. Each product worn bilaterally (in both eyes) for 1 week on a daily wear basis, as randomized | Senofilcon A contact lenses worn in Period 1, followed by verofilcon A contact lenses worn in Period 2. Each product worn bilaterally for 1 week on a daily wear basis, as randomized | Verofilcon A contact lenses worn in Period 1, followed by stenfilcon A contact lenses worn in Period 2. Each product worn bilaterally for 1 week on a daily wear basis, as randomized | Stenfilcon A contact lenses worn in Period 1, followed by verofilcon A contact lenses worn in Period 2. Each product worn bilaterally for 1 week on a daily wear basis, as randomized | Verofilcon A contact lenses worn in Period 1, followed by etafilcon A contact lenses worn in Period 2. Each product worn bilaterally for 1 week on a daily wear basis, as randomized | Etafilcon A contact lenses worn in Period 1, followed by verofilcon A contact lenses worn in Period 2. Each product worn bilaterally for 1 week on a daily wear basis, as randomized |
Period Title: Period 1, First Week of Wear | ||||||
STARTED | 11 | 11 | 11 | 11 | 11 | 11 |
COMPLETED | 11 | 11 | 11 | 11 | 11 | 11 |
NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 |
Period Title: Period 1, First Week of Wear | ||||||
STARTED | 11 | 11 | 11 | 11 | 11 | 11 |
COMPLETED | 11 | 11 | 11 | 11 | 11 | 11 |
NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Overall |
---|---|
Arm/Group Description | Verofilcon A contact lenses with corresponding control product (senofilcon A, stenfilcon A, or etafilcon) worn during Period 1 and Period 2 in a crossover assignment, as randomized. |
Overall Participants | 66 |
Age (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] |
32.9
(9.1)
|
Sex: Female, Male (Count of Participants) | |
Female |
46
69.7%
|
Male |
20
30.3%
|
Race/Ethnicity, Customized (Count of Participants) | |
White |
56
84.8%
|
Black or African American |
6
9.1%
|
American Indian or Alaska Native |
0
0%
|
Asian |
4
6.1%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
Outcome Measures
Title | Overall Quality of Vision |
---|---|
Description | Overall quality of vision was collected binocularly and rated on a 10-point scale with 1 = poor to 10 = excellent. Subjects were asked "Thinking back over the last week, please rate our study lenses. Rate eyes together." No formal hypotheses was conducted; hence no inferential testing was performed. |
Time Frame | Day 8, each product |
Outcome Measure Data
Analysis Population Description |
---|
Safety Analysis Set |
Arm/Group Title | DD T2 (Sequence 1 and 2) | Oasys 1-Day (Sequence 1 and 2) | DD T2 (Sequence 3 and 4) | MyDay (Sequence 3 and 4) | DD T2 (Sequence 5 and 6) | Moist (Sequence 5 and 6) |
---|---|---|---|---|---|---|
Arm/Group Description | Verofilcon A contact lenses worn in Period 1 or Period 2 for 1 week | Senofilcon A contact lenses worn in Period 1 or Period 2 for 1 week | Verofilcon A contact lenses worn in Period 1 or Period 2 for 1 week | Stenfilcon A contact lenses worn in Period 1 or Period 2 for 1 week | Verofilcon A contact lenses worn in Period 1 or Period 2 for 1 week | Etafilcon A contact lenses worn in Period 1 or Period 2 for 1 week |
Measure Participants | 22 | 22 | 22 | 22 | 22 | 22 |
Mean (Standard Deviation) [units on a scale] |
8.5
(1.4)
|
9.2
(1.3)
|
8.8
(1.8)
|
9.4
(0.8)
|
9.2
(1.1)
|
8.8
(1.7)
|
Adverse Events
Time Frame | Dispense through study completion, an average of 2 weeks | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | An adverse event (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. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Safety Analysis Set, based on treatment-specific exposure. | |||||||||||
Arm/Group Title | DD T2 (Sequence 1 and 2) | Oasys 1- Day (Sequence 1 and 2) | DD T2 (Sequence 3 and 4) | MyDay (Sequence 3 and 4) | DD T2 (Sequence 5 and 6) | Moist (Sequence 5 and 6) | ||||||
Arm/Group Description | Verofilcon A contact lenses worn in Period 1 or Period 2 for 1 week | Senofilcon A contact lenses worn in Period 1 or Period 2 for 1 week | Verofilcon A contact lenses worn in Period 1 or Period 2 for 1 week | Stenfilcon A contact lenses worn in Period 1 or Period 2 for 1 week | Verofilcon A contact lenses worn in Period 1 or Period 2 for 1 week | Etafilcon A contact lenses worn in Period 1 or Period 2 for 1 week | ||||||
All Cause Mortality |
||||||||||||
DD T2 (Sequence 1 and 2) | Oasys 1- Day (Sequence 1 and 2) | DD T2 (Sequence 3 and 4) | MyDay (Sequence 3 and 4) | DD T2 (Sequence 5 and 6) | Moist (Sequence 5 and 6) | |||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) | ||||||
Serious Adverse Events |
||||||||||||
DD T2 (Sequence 1 and 2) | Oasys 1- Day (Sequence 1 and 2) | DD T2 (Sequence 3 and 4) | MyDay (Sequence 3 and 4) | DD T2 (Sequence 5 and 6) | Moist (Sequence 5 and 6) | |||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) | ||||||
Other (Not Including Serious) Adverse Events |
||||||||||||
DD T2 (Sequence 1 and 2) | Oasys 1- Day (Sequence 1 and 2) | DD T2 (Sequence 3 and 4) | MyDay (Sequence 3 and 4) | DD T2 (Sequence 5 and 6) | Moist (Sequence 5 and 6) | |||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) | 0/22 (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 | Senior Clinical Project Lead, GCRA - Vision Care |
---|---|
Organization | Alcon, A Novartis Division |
Phone | 1-888-451-3937 |
alcon.medinfo@alcon.com |
- CLE383-C004