Clinical Biocompatibility Evaluation of Contact Lens Coatings
1 other identifier
interventional
33
1 country
1
Brief Summary
The primary objective is to evaluate corneal staining observed after 2 hours of wear with contact lenses with investigational coating against PureVision™ lenses, all pre-cycled with OPTI-FREE® RepleniSH® multi-purpose disinfection solution.
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 Feb 2017
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
January 25, 2017
CompletedFirst Posted
Study publicly available on registry
January 27, 2017
CompletedStudy Start
First participant enrolled
February 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 14, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 14, 2017
CompletedResults Posted
Study results publicly available
February 18, 2020
CompletedFebruary 18, 2020
February 1, 2020
28 days
January 25, 2017
February 5, 2020
February 5, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Average Percent Area of Solution-related 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. A higher percentage reflects more damage to the corneal surface. Both eyes contributed to the analysis. No hypotheses were formulated; no inferences were made and only descriptive statistics were used in the reporting.
Day 1 after 2 hours of wear, each product
Study Arms (4)
Test 1/Control 1, then Control 2/Test 2
OTHERContact lens with investigational coating 1 in right eye, with balafilcon A contact lens in left eye during Period 1, followed by balafilcon A contact lens in right eye, with contact lens with investigational coating 2 in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.
Test 2/Control 2, then Control 1/Test 1
OTHERContact lens with investigational coating 2 in right eye, with balafilcon A contact lens in left eye during Period 1, followed by balafilcon A contact lens in right eye, with contact lens with investigational coating 1 in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.
Control 1/Test 1, then Test 2/Control 2
OTHERBalafilcon A contact lens in right eye, with contact lens with investigational coating 1 in left eye during Period 1, followed by contact lens with investigational coating 2 in right eye, with balafilcon A contact lens in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.
Control 2/Test 2, then Test 1/Control 1
OTHERBalafilcon A contact lens in right eye, with contact lens with investigational coating 2 in left eye during Period 1, followed by contact lens with investigational coating 1 in right eye, with balafilcon A contact lens in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.
Interventions
Contact lens with investigational coating 1 pre-cycled in OPTI-FREE® RepleniSH® Multi-Purpose Disinfecting Solution (MPDS)
Balafilcon A contact lens pre-cycled OPTI-FREE® RepleniSH® MPDS
Multipurpose contact lens solution
Contact lens with investigational coating 2 pre-cycled in OPTI-FREE® RepleniSH® MPDS
Eligibility Criteria
You may qualify if:
- Able to understand and must sign an Informed Consent;
- Successful wearer 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 less than or equal to 1.50 diopter (D) in each eye;
- Best Corrected Visual Acuity (BCVA) 20/25 or better in each eye;
- VA with habitual spectacles 20/40 in both eyes (OU) or better and willing to wear spectacles as needed during the washout period and during study lens exposure;
You may not qualify if:
- Any anterior segment infection, inflammation, abnormality or disease that contraindicates contact lens wear;
- Any use of systemic or ocular medications for which contact lens wear could be contraindicated;
- History of refractive surgery or plan to have refractive surgery during the study or irregular cornea in either eye;
- Ocular or intra-ocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study;
- Current or history of pathologically dry eye in either eye that would preclude contact lens wear;
- Current or history of herpetic keratitis in either eye;
- Eye injury in either eye within 12 weeks immediately prior to enrollment;
- History of intolerance or hypersensitivity to any component of the study lenses or solutions;
- 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;
- Use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (1)
Alcon Investigative Site
Johns Creek, Georgia, 30097, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sr CDMA Project Lead, GCRA - Vision Care
- Organization
- Alcon, A Novartis Division
Study Officials
- STUDY DIRECTOR
Sr. Clinical Manager, Trial Management Operations
Alcon, A Novartis Division
Publication Agreements
- PI is Sponsor Employee
- 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
January 25, 2017
First Posted
January 27, 2017
Study Start
February 14, 2017
Primary Completion
March 14, 2017
Study Completion
March 14, 2017
Last Updated
February 18, 2020
Results First Posted
February 18, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share