Back to resultsClinical Performance of a Silicone Hydrogel Contact Lens Following Six Nights of Extended Wear
Primary Purpose
Refractive Errors
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LID011121 contact lens
Comfilcon A contact lens
Sponsored by
About this trial
This is an interventional treatment trial for Refractive Errors focused on measuring Contact Lens, Extended Wear, Overnight Wear, Contralateral Wear, Vision Correction
Eligibility Criteria
Key Inclusion Criteria:
- Able to understand and sign an Institutional Review Board/Ethics Committee-approved Informed Consent form.
- Successful wear of spherical soft contact lenses in both eyes during the past 3 months for a minimum of 5 days per week and in an extended wear modality a minimum of 1 night per week.
- Best Corrected Visual Acuity (BCVA) of 20/25 or better in each eye.
- Other protocol-specified inclusion criteria may apply.
Key Exclusion Criteria:
- Any condition, use of medications, or surgery that could contraindicate contact lens wear, as determined by the Investigator.
- Current Biofinity© lens wearer.
- Pregnant or breast-feeding.
- Other protocol-specified exclusion criteria may apply.
Sites / Locations
- Alcon Investigative Site
- Alcon Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
LID011121 (OD) / Biofinity (OS)
Biofinity (OD) / LID011121 (OS)
Arm Description
LID011121 contact lens worn in the right eye, with comfilcon A contact lens worn in the left eye, as randomized, for approximately 6 nights of extended (overnight) wear
Comfilcon A contact lens worn in the right eye, with LID011121 contact lens worn in the left eye, as randomized, for approximately 6 nights of extended (overnight) wear
Outcomes
Primary Outcome Measures
Visual Acuity (VA) With Study Lenses, Collected by Eye
Visual acuity (VA) was assessed for each eye individually with study lenses in place using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03614130
Brief Title
Clinical Performance of a Silicone Hydrogel Contact Lens Following Six Nights of Extended Wear
Official Title
Clinical Performance of a Silicone Hydrogel Following Six Nights of Extended Wear
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
August 23, 2018 (Actual)
Primary Completion Date
September 11, 2018 (Actual)
Study Completion Date
September 11, 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
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this clinical study is to evaluate the on-eye performance of an investigational soft contact lens compared to a commercially available soft contact lens following 1 week of extended wear.
Detailed Description
Subjects will be randomized to wear the investigational contact lens in 1 eye and the commercially available contact lens in the other eye. Subjects will be expected to attend 3 scheduled study visits: Day 1 Baseline/Dispense; Day 2 Follow-up; and Week 1 Follow-up/Exit. The expected duration of exposure to each of the study lenses for all randomized, completed subjects was approximately 7 days / 6 nights of wear.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Errors
Keywords
Contact Lens, Extended Wear, Overnight Wear, Contralateral Wear, Vision Correction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
In this contralateral study, subjects will be randomized to wear the investigational lens in 1 eye and the control lens in the other eye.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LID011121 (OD) / Biofinity (OS)
Arm Type
Other
Arm Description
LID011121 contact lens worn in the right eye, with comfilcon A contact lens worn in the left eye, as randomized, for approximately 6 nights of extended (overnight) wear
Arm Title
Biofinity (OD) / LID011121 (OS)
Arm Type
Other
Arm Description
Comfilcon A contact lens worn in the right eye, with LID011121 contact lens worn in the left eye, as randomized, for approximately 6 nights of extended (overnight) wear
Intervention Type
Device
Intervention Name(s)
LID011121 contact lens
Intervention Description
Investigational silicone hydrogel contact lens
Intervention Type
Device
Intervention Name(s)
Comfilcon A contact lens
Other Intervention Name(s)
Biofinity
Intervention Description
Commercially available silicone hydrogel contact lens
Primary Outcome Measure Information:
Title
Visual Acuity (VA) With Study Lenses, Collected by Eye
Description
Visual acuity (VA) was assessed for each eye individually with study lenses in place using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.
Time Frame
Day 1 Dispense; Day 2 Follow-up (ideally within 4 hours of awakening); Week 1 Follow-up/Exit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Able to understand and sign an Institutional Review Board/Ethics Committee-approved Informed Consent form.
Successful wear of spherical soft contact lenses in both eyes during the past 3 months for a minimum of 5 days per week and in an extended wear modality a minimum of 1 night per week.
Best Corrected Visual Acuity (BCVA) of 20/25 or better in each eye.
Other protocol-specified inclusion criteria may apply.
Key Exclusion Criteria:
Any condition, use of medications, or surgery that could contraindicate contact lens wear, as determined by the Investigator.
Current Biofinity© lens wearer.
Pregnant or breast-feeding.
Other protocol-specified exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CDMA Project Lead, Vision Care
Organizational Affiliation
Alcon Research, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Alcon Investigative Site
City
Johns Creek
State/Province
Georgia
ZIP/Postal Code
30097
Country
United States
Facility Name
Alcon Investigative Site
City
Brentwood
State/Province
Tennessee
ZIP/Postal Code
37027
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Performance of a Silicone Hydrogel Contact Lens Following Six Nights of Extended Wear
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