Back to resultsThree Daily Wear Monthly Replacement Silicone Hydrogel Contact Lenses With Two Multi-purpose Disinfecting Solution Combinations
Primary Purpose
Refractive Errors
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LID018869+RepleniSH
LID018869+Biotrue
Biofinity+RepleniSH
PV+Biotrue
Sponsored by
About this trial
This is an interventional treatment trial for Refractive Errors focused on measuring contact lens, contact lens solution
Eligibility Criteria
Key Inclusion Criteria:
- Understand and sign an Informed Consent;
- Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
- Manifest cylinder of less than or equal to 1.50 diopter (D) in each eye;
- Best corrected visual acuity (BCVA) better than or equal to 20/25 Snellen in each eye;
- Willing to stop wearing habitual contact lenses for the duration of study lens exposure and during the washout period.
- Other protocol-specified inclusion criteria may apply.
Key Exclusion Criteria:
- Any eye condition or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator;
- Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
- Eye surgery, as specified in the protocol;
- Dry eye; use of artificial tears, as specified in the protocol;
- Other protocol-specified exclusion criteria may apply.
Sites / Locations
- Alcon Investigator 6565
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Other
Other
Other
Arm Label
Sequence 1
Sequence 2
Sequence 3
Sequence 4
Arm Description
LID018869+RepleniSH in the right eye and Biofinity+RepleniSH in the left eye (first wear period), followed by PV+Biotrue in the right eye and LID018869+Biotrue in the left eye (second wear period). Each wear period will be 2 hours.
Biofinity+RepleniSH in the right eye and LID018869+RepleniSH in the left eye (first wear period), followed by LID018869+Biotrue in the right eye and PV+Biotrue in the left eye (second wear period). Each wear period will be 2 hours.
LID018869+Biotrue in the right eye and PV+Biotrue in the left eye (first wear period), followed by Biofinity+RepleniSH in the right eye and LID018869+RepleniSH in the left eye (second wear period). Each wear period will be 2 hours.
PV+Biotrue in the right eye and LID018869+Biotrue in the left eye (first wear period), followed by LID018869+RepleniSH in the right eye and Biofinity+RepleniSH the left eye (second wear period). Each wear period will be 2 hours.
Outcomes
Primary Outcome Measures
Average Percent Area of Corneal Staining
A slit lamp examination was performed by the investigator to assess corneal staining. Percent of solution-related corneal staining area was assessed first in each of the 5 corneal regions: central, superior, nasal, inferior, and temporal. The average of corneal staining area was then calculated as the average over all 5 regions. Each eye was treated differently and was graded separately. No hypotheses were formulated; no inferences were made, and only descriptive statistics were used in the reporting.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04789382
Brief Title
Three Daily Wear Monthly Replacement Silicone Hydrogel Contact Lenses With Two Multi-purpose Disinfecting Solution Combinations
Official Title
Clinical Biocompatibility of Three Daily Wear Monthly Replacement Silicone Hydrogel Contact Lenses With Two Multi-purpose Disinfecting Solution Combinations
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
April 7, 2021 (Actual)
Primary Completion Date
May 7, 2021 (Actual)
Study Completion Date
May 7, 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 purpose of this study is to evaluate corneal staining observed after 2 hours of wear with an investigational contact lens against both PureVision contact lenses pre-cycled with Biotrue and Biofinity contact lenses pre-cycled with RepleniSH.
Detailed Description
Subjects will be randomized in a 1:1:1:1 manner to receive one of 4 regimen sequences with lens and multipurpose disinfection solution (MPDS) combinations. The expected duration of subject participation in the study is approximately 1 week with 2 study visit days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Errors
Keywords
contact lens, contact lens solution
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sequence 1
Arm Type
Other
Arm Description
LID018869+RepleniSH in the right eye and Biofinity+RepleniSH in the left eye (first wear period), followed by PV+Biotrue in the right eye and LID018869+Biotrue in the left eye (second wear period). Each wear period will be 2 hours.
Arm Title
Sequence 2
Arm Type
Other
Arm Description
Biofinity+RepleniSH in the right eye and LID018869+RepleniSH in the left eye (first wear period), followed by LID018869+Biotrue in the right eye and PV+Biotrue in the left eye (second wear period). Each wear period will be 2 hours.
Arm Title
Sequence 3
Arm Type
Other
Arm Description
LID018869+Biotrue in the right eye and PV+Biotrue in the left eye (first wear period), followed by Biofinity+RepleniSH in the right eye and LID018869+RepleniSH in the left eye (second wear period). Each wear period will be 2 hours.
Arm Title
Sequence 4
Arm Type
Other
Arm Description
PV+Biotrue in the right eye and LID018869+Biotrue in the left eye (first wear period), followed by LID018869+RepleniSH in the right eye and Biofinity+RepleniSH the left eye (second wear period). Each wear period will be 2 hours.
Intervention Type
Device
Intervention Name(s)
LID018869+RepleniSH
Intervention Description
Lehfilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with OPTI-FREE® RepleniSH® multi-purpose disinfecting solution (RepleniSH)
Intervention Type
Device
Intervention Name(s)
LID018869+Biotrue
Intervention Description
Lehfilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with Biotrue® multi-purpose solution (Biotrue)
Intervention Type
Device
Intervention Name(s)
Biofinity+RepleniSH
Intervention Description
Comfilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with OPTI-FREE® RepleniSH® multi-purpose disinfecting solution (RepleniSH)
Intervention Type
Device
Intervention Name(s)
PV+Biotrue
Intervention Description
Balafilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with Biotrue® multi-purpose solution (Biotrue)
Primary Outcome Measure Information:
Title
Average Percent Area of Corneal Staining
Description
A slit lamp examination was performed by the investigator to assess corneal staining. Percent of solution-related corneal staining area was assessed first in each of the 5 corneal regions: central, superior, nasal, inferior, and temporal. The average of corneal staining area was then calculated as the average over all 5 regions. Each eye was treated differently and was graded separately. No hypotheses were formulated; no inferences were made, and only descriptive statistics were used in the reporting.
Time Frame
Hour 2 (each wear period)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Understand and sign an Informed Consent;
Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
Manifest cylinder of less than or equal to 1.50 diopter (D) in each eye;
Best corrected visual acuity (BCVA) better than or equal to 20/25 Snellen in each eye;
Willing to stop wearing habitual contact lenses for the duration of study lens exposure and during the washout period.
Other protocol-specified inclusion criteria may apply.
Key Exclusion Criteria:
Any eye condition or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator;
Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
Eye surgery, as specified in the protocol;
Dry eye; use of artificial tears, as specified in the protocol;
Other protocol-specified exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Lead, 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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Three Daily Wear Monthly Replacement Silicone Hydrogel Contact Lenses With Two Multi-purpose Disinfecting Solution Combinations
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