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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

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.

Condition or disease Intervention/treatment Phase
Refractive Errors Ametropia Device: Contact lens with investigational coating 1 Device: Balafilcon A contact lens Device: OPTI-FREE® RepleniSH® MPDS Device: Contact lens with investigational coating 2 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Biocompatibility Evaluation of Contact Lens Coatings
Actual Study Start Date : February 14, 2017
Actual Primary Completion Date : March 14, 2017
Actual Study Completion Date : March 14, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
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.
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

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.
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

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.
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

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.
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




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03034928


Locations
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United States, Georgia
Alcon Investigative Site
Johns Creek, Georgia, United States, 30097
Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Sr. Clinical Manager, Trial Management Operations Alcon, A Novartis Division
  Study Documents (Full-Text)

Documents provided by Alcon Research:
Study Protocol  [PDF] December 9, 2016
Statistical Analysis Plan  [PDF] January 5, 2017

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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT03034928    
Other Study ID Numbers: CLY935-E002
First Posted: January 27, 2017    Key Record Dates
Results First Posted: February 18, 2020
Last Update Posted: February 18, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Refractive Errors
Eye Diseases