Evaluate the Safety and Effectiveness of the Biotrue ONEday for Astigmatism

Sponsor
Bausch & Lomb Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT03681808
Collaborator
(none)
242
Enrollment
13
Locations
2
Arms
14.2
Actual Duration (Months)
18.6
Patients Per Site
1.3
Patients Per Site Per Month

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 DiseaseIntervention/TreatmentPhase
  • Device: Control
  • Device: Test
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

Study Type:
Interventional
Actual Enrollment :
242 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Investigator/Sponsor masked, randomized, open-label, parallel-group, multicenter studyInvestigator/Sponsor masked, randomized, open-label, parallel-group, multicenter study
Masking:
Single (Investigator)
Masking Description:
Subjects will be dispensed product according to the treatment arm corresponding to their randomization and will be unmasked. The Investigator will be masked.
Primary Purpose:
Treatment
Official Title:
A Study to Evaluate the Safety and Effectiveness of the Biotrue ONEday for Astigmatism Soft Contact Lens When Worn on a Daily Basis
Actual Study Start Date :
Oct 10, 2018
Actual Primary Completion Date :
Dec 16, 2019
Actual Study Completion Date :
Dec 16, 2019

Arms and Interventions

ArmIntervention/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

  1. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

SiteCityStateCountryPostal Code
1Bausch Site 117IrvineCaliforniaUnited States92618
2Bausch Site 107San DiegoCaliforniaUnited States92123
3Bausch Site 101San FranciscoCaliforniaUnited States94112
4Bausch Site 108San JoseCaliforniaUnited States95132
5Bausch Site 104SunnyvaleCaliforniaUnited States94087
6Bausch Site 102JacksonvilleFloridaUnited States32250
7Bausch Site 116BloomingtonIllinoisUnited States61701
8Bausch Site 110BrightonNew YorkUnited States14618
9Bausch Site 118New YorkNew YorkUnited States10022
10Bausch Site 111New YorkNew YorkUnited States10036
11Bausch Site 114RaleighNorth CarolinaUnited States27603
12Bausch Site 105HoustonTexasUnited States77204
13Bausch Site 115IssaquahWashingtonUnited States98027

Sponsors and Collaborators

  • Bausch & Lomb Incorporated

Investigators

  • Study Director: Lindsey Mathew, Bausch Health Companies

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT03681808
Other Study ID Numbers:
  • 885
First Posted:
Sep 24, 2018
Last Update Posted:
Jan 8, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group TitleBiotrueAcuvue
Arm/Group DescriptionBiotrue ONEday for Astigmatism Soft Contact Lens®1-Day Acuvue Moist for Astigmatism Contact Lens
Period Title: Overall Study
STARTED123119
COMPLETED109102
NOT COMPLETED1417

Baseline Characteristics

Arm/Group TitleBiotrueAcuvueTotal
Arm/Group DescriptionBiotrue ONEday for Astigmatism Soft Contact Lens®1-Day Acuvue Moist for Astigmatism Contact LensTotal of all reporting groups
Overall Participants123119242
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

1. Primary Outcome
TitleProportion of Participants Achieving a Contact Lens Corrected Distance logMAR VA of 0.04 or Better
DescriptionThe proportion of participants achieving a contact lens corrected distance logMAR VA of 0.04 or better in both eyes
Time FrameEvaluated 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 TitleBiotrueAcuvue
Arm/Group DescriptionBiotrue ONEday for Astigmatism Soft Contact Lens®1-Day Acuvue Moist for Astigmatism Contact Lens
Measure Participants10698
Count of Participants [Participants]
105
85.4%
92
77.3%

Adverse Events

Time Frame3 months
Adverse Event Reporting Description
Arm/Group TitleBiotrueAcuvue
Arm/Group DescriptionBiotrue ONEday for Astigmatism Soft Contact Lens®1-Day Acuvue Moist for Astigmatism Contact Lens
All Cause Mortality
BiotrueAcuvue
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/123 (0%) 0/119 (0%)
Serious Adverse Events
BiotrueAcuvue
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/123 (0%) 0/119 (0%)
Other (Not Including Serious) Adverse Events
BiotrueAcuvue
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/123 (0%) 0/119 (0%)

Limitations/Caveats

[Not Specified]

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/TitleStudy Director
OrganizationBausch & Lomb
Phone585-338-6399
EmailRobert.Steffen@bausch.com
Responsible Party:
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT03681808
Other Study ID Numbers:
  • 885
First Posted:
Sep 24, 2018
Last Update Posted:
Jan 8, 2021
Last Verified:
Jan 1, 2021