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Clinical Biocompatibility Evaluation of Contact Lens Coatings

Primary Purpose

Refractive Errors, Ametropia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Contact lens with investigational coating 1
Balafilcon A contact lens
OPTI-FREE® RepleniSH® MPDS
Contact lens with investigational coating 2
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractive Errors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Alcon Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Test 1/Control 1, then Control 2/Test 2

Test 2/Control 2, then Control 1/Test 1

Control 1/Test 1, then Test 2/Control 2

Control 2/Test 2, then Test 1/Control 1

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 25, 2017
Last Updated
February 5, 2020
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT03034928
Brief Title
Clinical Biocompatibility Evaluation of Contact Lens Coatings
Official Title
Clinical Biocompatibility Evaluation of Contact Lens Coatings
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
February 14, 2017 (Actual)
Primary Completion Date
March 14, 2017 (Actual)
Study Completion Date
March 14, 2017 (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
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Errors, Ametropia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test 1/Control 1, then Control 2/Test 2
Arm Type
Other
Arm Description
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.
Arm Title
Test 2/Control 2, then Control 1/Test 1
Arm Type
Other
Arm Description
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.
Arm Title
Control 1/Test 1, then Test 2/Control 2
Arm Type
Other
Arm Description
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.
Arm Title
Control 2/Test 2, then Test 1/Control 1
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Contact lens with investigational coating 1
Other Intervention Name(s)
Test 1
Intervention Description
Contact lens with investigational coating 1 pre-cycled in OPTI-FREE® RepleniSH® Multi-Purpose Disinfecting Solution (MPDS)
Intervention Type
Device
Intervention Name(s)
Balafilcon A contact lens
Other Intervention Name(s)
Bausch & Lomb PureVision™, Control 1, Control 2
Intervention Description
Balafilcon A contact lens pre-cycled OPTI-FREE® RepleniSH® MPDS
Intervention Type
Device
Intervention Name(s)
OPTI-FREE® RepleniSH® MPDS
Intervention Description
Multipurpose contact lens solution
Intervention Type
Device
Intervention Name(s)
Contact lens with investigational coating 2
Other Intervention Name(s)
Test 2
Intervention Description
Contact lens with investigational coating 2 pre-cycled in OPTI-FREE® RepleniSH® MPDS
Primary Outcome Measure Information:
Title
Average Percent Area of Solution-related Corneal Staining
Description
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.
Time Frame
Day 1 after 2 hours of wear, each product

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sr. Clinical Manager, Trial Management Operations
Organizational Affiliation
Alcon, A Novartis Division
Official's Role
Study Director
Facility Information:
Facility Name
Alcon Investigative Site
City
Johns Creek
State/Province
Georgia
ZIP/Postal Code
30097
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Biocompatibility Evaluation of Contact Lens Coatings

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