Back to resultsClinical Characterization of an Investigational Frequent Replacement Daily Wear Silicone Hydrogel Sphere Contact Lens
Primary Purpose
Refractive Errors
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LID021201 contact lenses
OPTI-FREE multipurpose solution
Sponsored by
About this trial
This is an interventional treatment trial for Refractive Errors focused on measuring Vision, Contact lenses
Eligibility Criteria
Inclusion Criteria:
- Understand and sign an Informed Consent that has been approved by an Institutional Review Board.
- Successful wear of spherical daily wear frequent replacement soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months.
- Willing to stop wearing habitual contact lenses for the duration of study participation.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Any condition that contraindicates contact lens wear, as determined by the Investigator.
- Any use of systemic or ocular medications that contraindicates contact lens wear, as determined by the Investigator.
- History of refractive surgery or plan to have refractive surgery during the study.
- Current or history of dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear.
- Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
- Alcon Investigator 6565
- Alcon Investigator 6353
- Alcon Investigator 8028
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LID021201
Arm Description
LID021201 contact lenses worn in both eyes for 7 days. Lenses will be removed nightly for cleaning and disinfection with OPTI-FREE multipurpose solution.
Outcomes
Primary Outcome Measures
Front Surface Wettability, by Category
Front surface wettability (i.e., assessment of the disruption of the front surface wettability of the contact lens) was assessed by the investigator for each eye individually. Front surface wettability was collected on a 5-point scale, where where Grade 0 = a smooth uniformly reflecting surface, Grade 1 = a coarse hazy surface which seems resolved momentarily with each blink and becomes exacerbated with staring, Grade 2 = one stable dry (non-wetting) area of some magnitude, Grade 3 = more than one stable dry (non-wetting) area of some magnitude, and Grade 4 = non-wettable lens surface. No formal hypothesis was predefined for the primary endpoint. No inferential testing was performed.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04702984
Brief Title
Clinical Characterization of an Investigational Frequent Replacement Daily Wear Silicone Hydrogel Sphere Contact Lens
Official Title
Clinical Characterization of an Investigational Frequent Replacement Daily Wear Silicone Hydrogel Sphere Contact Lens
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 21, 2021 (Actual)
Primary Completion Date
February 26, 2021 (Actual)
Study Completion Date
February 26, 2021 (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 primary objective of this study is to evaluate the overall clinical performance of an investigational silicone hydrogel contact lens over 7 days of daily wear.
Detailed Description
Participants will attend a Screening visit, a Dispense visit, and a Week 1 Follow-up/exit visit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Errors
Keywords
Vision, Contact lenses
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Lens will be provided with investigational product labeling
Allocation
N/A
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LID021201
Arm Type
Experimental
Arm Description
LID021201 contact lenses worn in both eyes for 7 days. Lenses will be removed nightly for cleaning and disinfection with OPTI-FREE multipurpose solution.
Intervention Type
Device
Intervention Name(s)
LID021201 contact lenses
Intervention Description
Investigational silicone hydrogel sphere contact lenses for frequent replacement daily wear
Intervention Type
Device
Intervention Name(s)
OPTI-FREE multipurpose solution
Other Intervention Name(s)
OPTI-FREE® RepleniSH®
Intervention Description
Solution for cleaning, disinfecting, and reconditioning silicone hydrogel contact lenses
Primary Outcome Measure Information:
Title
Front Surface Wettability, by Category
Description
Front surface wettability (i.e., assessment of the disruption of the front surface wettability of the contact lens) was assessed by the investigator for each eye individually. Front surface wettability was collected on a 5-point scale, where where Grade 0 = a smooth uniformly reflecting surface, Grade 1 = a coarse hazy surface which seems resolved momentarily with each blink and becomes exacerbated with staring, Grade 2 = one stable dry (non-wetting) area of some magnitude, Grade 3 = more than one stable dry (non-wetting) area of some magnitude, and Grade 4 = non-wettable lens surface. No formal hypothesis was predefined for the primary endpoint. No inferential testing was performed.
Time Frame
Dispense; Week 1 Follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Understand and sign an Informed Consent that has been approved by an Institutional Review Board.
Successful wear of spherical daily wear frequent replacement soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months.
Willing to stop wearing habitual contact lenses for the duration of study participation.
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Any condition that contraindicates contact lens wear, as determined by the Investigator.
Any use of systemic or ocular medications that contraindicates contact lens wear, as determined by the Investigator.
History of refractive surgery or plan to have refractive surgery during the study.
Current or history of dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear.
Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
Other protocol-defined exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sr. Clinical Trial Lead, CDMA Vision Care
Organizational Affiliation
Alcon Research, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Alcon Investigator 6565
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Alcon Investigator 6353
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38111
Country
United States
Facility Name
Alcon Investigator 8028
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76308
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Characterization of an Investigational Frequent Replacement Daily Wear Silicone Hydrogel Sphere Contact Lens
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