Back to resultsPilot Clinical Performance of a Silicone Hydrogel Lens for Up to Six Nights of Extended Wear
Primary Purpose
Refractive Errors, Myopia, Hyperopia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lehfilcon A contact lens
Comfilcon A contact lens
Sponsored by
About this trial
This is an interventional treatment trial for Refractive Errors focused on measuring Extended Wear, Contact Lens, Overnight Wear, Vision Correction, Contralateral Wear
Eligibility Criteria
Key Inclusion Criteria: Able to understand and sign an IRB/IEC 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/week and in an extended wear modality at least 1 night/week. Best corrected visual acuity 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. Any habitual wear of Biofinity contact lenses. Pregnant or breast-feeding. Other protocol specified exclusion criteria may apply.
Sites / Locations
- Alcon Investigator 6402
- Alcon Investigator 8046
- Alcon Investigator 2786
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LID018869 (OD) / Biofinity (OS)
Biofinity (OD) / LID018869 (OS)
Arm Description
Lehfilcon A contact lens worn in the right eye, with comfilcon A contact lens worn in the left eye, as randomized, for approximately 1 week of continuous wear
Comfilcon A contact lens worn in the right eye, with lehfilcon A contact lens worn in the left eye, as randomized, for approximately 1 week of continuous wear
Outcomes
Primary Outcome Measures
Distance Visual Acuity (VA) With Study Lenses
Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters 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
NCT04403542
Brief Title
Pilot Clinical Performance of a Silicone Hydrogel Lens for Up to Six Nights of Extended Wear
Official Title
Pilot Clinical Performance of a Silicone Hydrogel Lens for Up to Six Nights of Extended Wear
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 3, 2020 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
August 31, 2020 (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 when worn continuously for up to 1 week.
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 Screening/Baseline/Dispense; Day 2 Follow-up within 4 hours of awakening (after the first night of sleeping); 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, Myopia, Hyperopia
Keywords
Extended Wear, Contact Lens, Overnight Wear, Vision Correction, Contralateral Wear
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel 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
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LID018869 (OD) / Biofinity (OS)
Arm Type
Experimental
Arm Description
Lehfilcon A contact lens worn in the right eye, with comfilcon A contact lens worn in the left eye, as randomized, for approximately 1 week of continuous wear
Arm Title
Biofinity (OD) / LID018869 (OS)
Arm Type
Active Comparator
Arm Description
Comfilcon A contact lens worn in the right eye, with lehfilcon A contact lens worn in the left eye, as randomized, for approximately 1 week of continuous wear
Intervention Type
Device
Intervention Name(s)
Lehfilcon A contact lens
Other Intervention Name(s)
LID018869
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
Distance Visual Acuity (VA) With Study Lenses
Description
Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters 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 (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 IRB/IEC 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/week and in an extended wear modality at least 1 night/week.
Best corrected visual acuity 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.
Any habitual wear of Biofinity contact lenses.
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 Investigator 6402
City
Medina
State/Province
Minnesota
ZIP/Postal Code
55340
Country
United States
Facility Name
Alcon Investigator 8046
City
Granville
State/Province
Ohio
ZIP/Postal Code
43023
Country
United States
Facility Name
Alcon Investigator 2786
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pilot Clinical Performance of a Silicone Hydrogel Lens for Up to Six Nights of Extended Wear
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