Three Daily Wear Monthly Replacement Silicone Hydrogel Contact Lenses With Two Multi-purpose Disinfecting Solution Combinations
Clinical Biocompatibility of Three Daily Wear Monthly Replacement Silicone Hydrogel Contact Lenses With Two Multi-purpose Disinfecting Solution Combinations
1 other identifier
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2021
CompletedFirst Posted
Study publicly available on registry
March 9, 2021
CompletedStudy Start
First participant enrolled
April 7, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 7, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 7, 2021
CompletedResults Posted
Study results publicly available
May 3, 2022
CompletedMay 25, 2022
May 1, 2022
1 month
March 5, 2021
April 5, 2022
May 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Hour 2 (each wear period)
Study Arms (4)
Sequence 1
OTHERLID018869+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.
Sequence 2
OTHERBiofinity+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.
Sequence 3
OTHERLID018869+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.
Sequence 4
OTHERPV+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.
Interventions
Lehfilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with OPTI-FREE® RepleniSH® multi-purpose disinfecting solution (RepleniSH)
Lehfilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with Biotrue® multi-purpose solution (Biotrue)
Comfilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with OPTI-FREE® RepleniSH® multi-purpose disinfecting solution (RepleniSH)
Balafilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with Biotrue® multi-purpose solution (Biotrue)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (1)
Alcon Investigator 6565
Maitland, Florida, 32751, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- CDMA Project Lead, Vision Care
- Organization
- Alcon Research, LLC
Study Officials
- STUDY DIRECTOR
Clinical Trial Lead, Vision Care
Alcon Research, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2021
First Posted
March 9, 2021
Study Start
April 7, 2021
Primary Completion
May 7, 2021
Study Completion
May 7, 2021
Last Updated
May 25, 2022
Results First Posted
May 3, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share