Back to resultsClinical Characterization of an Investigational Soft Silicone Hydrogel Contact Lens
Primary Purpose
Refractive Errors
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lehfilcon A contact lenses
Multipurpose disinfection 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 weekly/monthly 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.
- Habitual contact lenses worn in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
- Any use of topical ocular medications or artificial tear or rewetting drops that would require instillation during contact lens wear.
- Monovision or multifocal contact lens wear.
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
- Alcon Investigative Site
- Alcon Investigative Site
- Alcon Investigative Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LID020098
Arm Description
Lehfilcon A contact lenses worn in both eyes for 2 weeks. Lenses will be removed nightly for cleaning and disinfection.
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 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
NCT04631796
Brief Title
Clinical Characterization of an Investigational Soft Silicone Hydrogel Contact Lens
Official Title
Clinical Characterization of an Investigational Soft Silicone Hydrogel Contact Lens
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
December 3, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 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
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 2 weeks of daily wear.
Detailed Description
Participants will attend a Screening visit, a Dispense visit (0 to 4 days later), and a follow-up visit approximately 2 weeks after the Dispense 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)
Allocation
N/A
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LID020098
Arm Type
Experimental
Arm Description
Lehfilcon A contact lenses worn in both eyes for 2 weeks. Lenses will be removed nightly for cleaning and disinfection.
Intervention Type
Device
Intervention Name(s)
Lehfilcon A contact lenses
Other Intervention Name(s)
LID020098
Intervention Description
Silicone hydrogel contact lenses with investigational coating
Intervention Type
Device
Intervention Name(s)
Multipurpose disinfection 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 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 2 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 weekly/monthly 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.
Habitual contact lenses worn in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
Any use of topical ocular medications or artificial tear or rewetting drops that would require instillation during contact lens wear.
Monovision or multifocal contact lens wear.
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
Official's Role
Study Director
Facility Information:
Facility Name
Alcon Investigative Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Alcon Investigative Site
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61704
Country
United States
Facility Name
Alcon Investigative Site
City
Powell
State/Province
Ohio
ZIP/Postal Code
43065
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Characterization of an Investigational Soft Silicone Hydrogel Contact Lens
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