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Clinical Biocompatibility Evaluation of Contact Lens Coatings

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03034928
Recruitment Status : Completed
First Posted : January 27, 2017
Results First Posted : February 18, 2020
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Tracking Information
First Submitted Date  ICMJE January 25, 2017
First Posted Date  ICMJE January 27, 2017
Results First Submitted Date  ICMJE February 5, 2020
Results First Posted Date  ICMJE February 18, 2020
Last Update Posted Date February 18, 2020
Actual Study Start Date  ICMJE February 14, 2017
Actual Primary Completion Date March 14, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2020)
Average Percent Area of Solution-related Corneal Staining [ Time Frame: Day 1 after 2 hours of wear, each product ]
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Biocompatibility Evaluation of Contact Lens Coatings
Official Title  ICMJE Clinical Biocompatibility Evaluation of Contact Lens Coatings
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.
Detailed Description In this contralateral crossover study, qualifying subjects will wear a total of 2 pairs of study contact lenses. Lenses will be worn according to a randomized lens sequence assignment. Each pair will consist of a test lens (Test 1 or Test 2) and a control lens.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Refractive Errors
  • Ametropia
Intervention  ICMJE
  • Device: Contact lens with investigational coating 1
    Contact lens with investigational coating 1 pre-cycled in OPTI-FREE® RepleniSH® Multi-Purpose Disinfecting Solution (MPDS)
    Other Name: Test 1
  • Device: Balafilcon A contact lens
    Balafilcon A contact lens pre-cycled OPTI-FREE® RepleniSH® MPDS
    Other Names:
    • Bausch & Lomb PureVision™
    • Control 1
    • Control 2
  • Device: OPTI-FREE® RepleniSH® MPDS
    Multipurpose contact lens solution
  • Device: Contact lens with investigational coating 2
    Contact lens with investigational coating 2 pre-cycled in OPTI-FREE® RepleniSH® MPDS
    Other Name: Test 2
Study Arms  ICMJE
  • Test 1/Control 1, then Control 2/Test 2
    Contact 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.
    Interventions:
    • Device: Contact lens with investigational coating 1
    • Device: Balafilcon A contact lens
    • Device: OPTI-FREE® RepleniSH® MPDS
    • Device: Contact lens with investigational coating 2
  • Test 2/Control 2, then Control 1/Test 1
    Contact 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.
    Interventions:
    • Device: Contact lens with investigational coating 1
    • Device: Balafilcon A contact lens
    • Device: OPTI-FREE® RepleniSH® MPDS
    • Device: Contact lens with investigational coating 2
  • Control 1/Test 1, then Test 2/Control 2
    Balafilcon 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.
    Interventions:
    • Device: Contact lens with investigational coating 1
    • Device: Balafilcon A contact lens
    • Device: OPTI-FREE® RepleniSH® MPDS
    • Device: Contact lens with investigational coating 2
  • Control 2/Test 2, then Test 1/Control 1
    Balafilcon 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:
    • Device: Contact lens with investigational coating 1
    • Device: Balafilcon A contact lens
    • Device: OPTI-FREE® RepleniSH® MPDS
    • Device: Contact lens with investigational coating 2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 5, 2020)
33
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 14, 2017
Actual Primary Completion Date March 14, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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;
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  • 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;
  • Other protocol-specified exclusion criteria may apply.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03034928
Other Study ID Numbers  ICMJE CLY935-E002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Alcon Research
Study Sponsor  ICMJE Alcon Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sr. Clinical Manager, Trial Management Operations Alcon, A Novartis Division
PRS Account Alcon Research
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP