Back to resultsClinical Evaluation of Two Monthly Contact Lenses
Primary Purpose
Refractive Errors
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Comfilcon A with Digital Zone Optics™ contact lenses
Comfilcon A contact lenses
Sponsored by
About this trial
This is an interventional treatment trial for Refractive Errors
Eligibility Criteria
Inclusion Criteria:
- Able to understand and sign an approved informed consent form (ICF);
- Successful wear of BIOFINITY® (spherical) (or private label) 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 (BCVA) 20/25 or better in each eye;
- Possess spectacles that provide a corrected visual acuity of 20/40 or better in both eyes (OU) and be willing to wear them (as needed);
- Currently using digital devices (computer, tablet, and/or smart phone) for a minimum of 5 days per week and 4 hours per day;
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
- Any anterior segment infection, inflammation, abnormality or disease that contraindicates contact lens wear;
- Any use of systemic or ocular medications for which contact lens wear could be contraindicated;
- Refractive, ocular, or intraocular surgery, as specified in the protocol;
- Current or history of eye injury or disorders, as specified in the protocol;
- Current or history of intolerance, hypersensitivity or allergy to any component of the study products;
- Habitual contact lens wear in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
- Use of topical ocular medications that would require instillation during contact lens wear;
- Other protocol-specified exclusion criteria may apply.
Sites / Locations
- Alcon Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
BIOFINITY ENERGYS then BIOFINITY
BIOFINITY then BIOFINITY ENERGYS
Arm Description
Comfilcon A with Digital Zone Optics™ contact lenses worn first, followed by comfilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for 7 days in a daily wear modality.
Comfilcon A contact lenses worn first, followed by comfilcon A with Digital Zone Optics™ contact lenses. Each product will be worn bilaterally (in both eyes) for 7 days in a daily wear modality.
Outcomes
Primary Outcome Measures
Subjective Rating of Overall Vision
Overall vision was assessed binocularly (both eyes together) by the subject on a 10-point scale, where 1=poor and 10=excellent. Inferential testing was not planned for this primary effectiveness endpoint.
Secondary Outcome Measures
Over-refraction
Over-refraction (amount of additional correction needed to improve visual acuity (VA)) was collected for each eye and measured in diopters (D). Inferential testing was not planned for this endpoint.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03459131
Brief Title
Clinical Evaluation of Two Monthly Contact Lenses
Official Title
Clinical Evaluation of Two Monthly Contact Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
March 7, 2018 (Actual)
Primary Completion Date
March 26, 2018 (Actual)
Study Completion Date
March 26, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to explore overall vision with BIOFINITY® ENERGYS™ contact lenses as compared to BIOFINITY® contact lenses after one week of wear.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Errors
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BIOFINITY ENERGYS then BIOFINITY
Arm Type
Other
Arm Description
Comfilcon A with Digital Zone Optics™ contact lenses worn first, followed by comfilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for 7 days in a daily wear modality.
Arm Title
BIOFINITY then BIOFINITY ENERGYS
Arm Type
Other
Arm Description
Comfilcon A contact lenses worn first, followed by comfilcon A with Digital Zone Optics™ contact lenses. Each product will be worn bilaterally (in both eyes) for 7 days in a daily wear modality.
Intervention Type
Device
Intervention Name(s)
Comfilcon A with Digital Zone Optics™ contact lenses
Other Intervention Name(s)
BIOFINITY® ENERGYS™
Intervention Description
Silicone hydrogel spherical contact lenses with Digital Zone Optics™
Intervention Type
Device
Intervention Name(s)
Comfilcon A contact lenses
Other Intervention Name(s)
BIOFINITY®
Intervention Description
Silicone hydrogel spherical contact lenses
Primary Outcome Measure Information:
Title
Subjective Rating of Overall Vision
Description
Overall vision was assessed binocularly (both eyes together) by the subject on a 10-point scale, where 1=poor and 10=excellent. Inferential testing was not planned for this primary effectiveness endpoint.
Time Frame
Day 7, each product
Secondary Outcome Measure Information:
Title
Over-refraction
Description
Over-refraction (amount of additional correction needed to improve visual acuity (VA)) was collected for each eye and measured in diopters (D). Inferential testing was not planned for this endpoint.
Time Frame
Day 1 (Dispense), each product
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Able to understand and sign an approved informed consent form (ICF);
Successful wear of BIOFINITY® (spherical) (or private label) 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 (BCVA) 20/25 or better in each eye;
Possess spectacles that provide a corrected visual acuity of 20/40 or better in both eyes (OU) and be willing to wear them (as needed);
Currently using digital devices (computer, tablet, and/or smart phone) for a minimum of 5 days per week and 4 hours per day;
Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
Any anterior segment infection, inflammation, abnormality or disease that contraindicates contact lens wear;
Any use of systemic or ocular medications for which contact lens wear could be contraindicated;
Refractive, ocular, or intraocular surgery, as specified in the protocol;
Current or history of eye injury or disorders, as specified in the protocol;
Current or history of intolerance, hypersensitivity or allergy to any component of the study products;
Habitual contact lens wear in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
Use of topical ocular medications that would require instillation during contact lens wear;
Other protocol-specified exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alcon, A Novartis Division
Organizational Affiliation
Alcon, A Novartis Division
Official's Role
Study Director
Facility Information:
Facility Name
Alcon Investigative Site
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Evaluation of Two Monthly Contact Lenses
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