Clinical Biocompatibility Evaluation of Contact Lens Coatings

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.

Study Overview

• Status: Completed
• Conditions: Refractive Errors; Ametropia
• Intervention / Treatment: Device: Contact lens with investigational coating 1; Device: Balafilcon A contact lens; Device: OPTI-FREE® RepleniSH® MPDS; Device: Contact lens with investigational coating 2

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: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Johns Creek, Georgia, United States, 30097
      • Alcon Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 Names: Test 1; Device: Balafilcon A contact lens; Balafilcon A contact lens pre-cycled OPTI-FREE® RepleniSH® MPDS; Other Names: Control 1; Bausch & Lomb PureVision™; 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 Names: Test 2
Other: 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 Names: Test 1; Device: Balafilcon A contact lens; Balafilcon A contact lens pre-cycled OPTI-FREE® RepleniSH® MPDS; Other Names: Control 1; Bausch & Lomb PureVision™; 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 Names: Test 2
Other: 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 Names: Test 1; Device: Balafilcon A contact lens; Balafilcon A contact lens pre-cycled OPTI-FREE® RepleniSH® MPDS; Other Names: Control 1; Bausch & Lomb PureVision™; 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 Names: Test 2
Other: 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 Names: Test 1; Device: Balafilcon A contact lens; Balafilcon A contact lens pre-cycled OPTI-FREE® RepleniSH® MPDS; Other Names: Control 1; Bausch & Lomb PureVision™; 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 Names: Test 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Sr. Clinical Manager, Trial Management Operations, Alcon, A Novartis Division

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2017
• Primary Completion (Actual): March 14, 2017
• Study Completion (Actual): March 14, 2017

Study Registration Dates

• First Submitted: January 25, 2017
• First Submitted That Met QC Criteria: January 25, 2017
• First Posted (Estimate): January 27, 2017

Study Record Updates

• Last Update Posted (Actual): February 18, 2020
• Last Update Submitted That Met QC Criteria: February 5, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CLY935-E002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes