Evaluate the Safety and Effectiveness of the Biotrue ONEday for Astigmatism
Study Details
Study Description
Brief Summary
Comparing Test Lens for Astigmatism Soft Contact Lens (Test) to 1-Day Control for Astigmatism contact lenses (Control).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
This is a multicenter, randomized 1:1, parallel-group, bilateral, Investigator-masked study at 13 investigative sites in the United States (US) in a population including Chinese subjects (maternal and paternal grandparents born in China)
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Test Soft Contact Lens |
Device: Test
Soft Contact Lens
|
Active Comparator: Control Contact lens |
Device: Control
Contact Lens
|
Outcome Measures
Primary Outcome Measures
- Proportion of Participants Achieving a Contact Lens Corrected Distance logMAR VA of 0.04 or Better [Evaluated at the 1 week follow up visit]
The proportion of participants achieving a contact lens corrected distance logMAR VA of 0.04 or better in both eyes
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject must be of legal age (at least 18 or as defined by state law) on the date the ICF is signed and have the capacity to provide voluntary informed consent.
-
Subject must be able to read, understand and provide written informed consent on the IRB approved ICF and provide authorization as appropriate for local privacy regulations.
-
Subject must have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings (greater than Grade 1 and/or presence of infiltrates) and have clear central 6 mm corneas.
-
Subject must be an adapted wearer of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
Exclusion Criteria:
-
Subject has worn gas permeable (GP) contact lenses within last 30 days or polymethylmethacrylate (PMMA) lenses within last 3 months.
-
Subject has systemic disease affecting ocular health.
-
Subject is using any systemic or topical medications that will affect ocular physiology or lens performance.
-
Subject has an active ocular disease (for example but not limited to papillary conjunctivitis, any conjunctivitis: viral, bacterial, allergic), any corneal infiltrative response or are using any ocular medications.
-
Subject has any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Bausch Site 117 | Irvine | California | United States | 92618 |
2 | Bausch Site 107 | San Diego | California | United States | 92123 |
3 | Bausch Site 101 | San Francisco | California | United States | 94112 |
4 | Bausch Site 108 | San Jose | California | United States | 95132 |
5 | Bausch Site 104 | Sunnyvale | California | United States | 94087 |
6 | Bausch Site 102 | Jacksonville | Florida | United States | 32250 |
7 | Bausch Site 116 | Bloomington | Illinois | United States | 61701 |
8 | Bausch Site 110 | Brighton | New York | United States | 14618 |
9 | Bausch Site 118 | New York | New York | United States | 10022 |
10 | Bausch Site 111 | New York | New York | United States | 10036 |
11 | Bausch Site 114 | Raleigh | North Carolina | United States | 27603 |
12 | Bausch Site 105 | Houston | Texas | United States | 77204 |
13 | Bausch Site 115 | Issaquah | Washington | United States | 98027 |
Sponsors and Collaborators
- Bausch & Lomb Incorporated
Investigators
- Study Director: Lindsey Mathew, Bausch Health Companies
Study Documents (Full-Text)
More Information
Publications
None provided.- 885
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Biotrue | Acuvue |
---|---|---|
Arm/Group Description | Biotrue ONEday for Astigmatism Soft Contact Lens® | 1-Day Acuvue Moist for Astigmatism Contact Lens |
Period Title: Overall Study | ||
STARTED | 123 | 119 |
COMPLETED | 109 | 102 |
NOT COMPLETED | 14 | 17 |
Baseline Characteristics
Arm/Group Title | Biotrue | Acuvue | Total |
---|---|---|---|
Arm/Group Description | Biotrue ONEday for Astigmatism Soft Contact Lens® | 1-Day Acuvue Moist for Astigmatism Contact Lens | Total of all reporting groups |
Overall Participants | 123 | 119 | 242 |
Age (years) [Mean (Full Range) ] | |||
Mean (Full Range) [years] |
33.7
|
32.9
|
33.3
|
Sex: Female, Male (Count of Participants) | |||
Female |
78
63.4%
|
72
60.5%
|
150
62%
|
Male |
45
36.6%
|
47
39.5%
|
92
38%
|
Race (NIH/OMB) (Count of Participants) | |||
American Indian or Alaska Native |
2
1.6%
|
1
0.8%
|
3
1.2%
|
Asian |
60
48.8%
|
59
49.6%
|
119
49.2%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
1
0.8%
|
1
0.4%
|
Black or African American |
16
13%
|
8
6.7%
|
24
9.9%
|
White |
42
34.1%
|
49
41.2%
|
91
37.6%
|
More than one race |
3
2.4%
|
0
0%
|
3
1.2%
|
Unknown or Not Reported |
0
0%
|
1
0.8%
|
1
0.4%
|
Ancestry (Count of Participants) | |||
Chinese |
45
36.6%
|
41
34.5%
|
86
35.5%
|
Non-Chinese |
78
63.4%
|
78
65.5%
|
156
64.5%
|
Outcome Measures
Title | Proportion of Participants Achieving a Contact Lens Corrected Distance logMAR VA of 0.04 or Better |
---|---|
Description | The proportion of participants achieving a contact lens corrected distance logMAR VA of 0.04 or better in both eyes |
Time Frame | Evaluated at the 1 week follow up visit |
Outcome Measure Data
Analysis Population Description |
---|
The Per Protocol (PP) Population included all randomized participants without major protocol deviations who completed the study. |
Arm/Group Title | Biotrue | Acuvue |
---|---|---|
Arm/Group Description | Biotrue ONEday for Astigmatism Soft Contact Lens® | 1-Day Acuvue Moist for Astigmatism Contact Lens |
Measure Participants | 106 | 98 |
Count of Participants [Participants] |
105
85.4%
|
92
77.3%
|
Adverse Events
Time Frame | 3 months | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Biotrue | Acuvue | ||
Arm/Group Description | Biotrue ONEday for Astigmatism Soft Contact Lens® | 1-Day Acuvue Moist for Astigmatism Contact Lens | ||
All Cause Mortality |
||||
Biotrue | Acuvue | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/123 (0%) | 0/119 (0%) | ||
Serious Adverse Events |
||||
Biotrue | Acuvue | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/123 (0%) | 0/119 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Biotrue | Acuvue | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/123 (0%) | 0/119 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Contact sponsor directly for details.
Results Point of Contact
Name/Title | Study Director |
---|---|
Organization | Bausch & Lomb |
Phone | 585-338-6399 |
Robert.Steffen@bausch.com |
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