Clinical Biocompatibility Evaluation of Contact Lens Coatings

Not Applicable

Completed

Conditions: Refractive Errors
Ametropia

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

Registration Number: NCT03034928

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 33

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 & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test 2/Control 2, then Control 1/Test 1	Contact lens with investigational coating 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.
Test 2/Control 2, then Control 1/Test 1	Balafilcon A contact lens	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.
Test 1/Control 1, then Control 2/Test 2	Balafilcon A contact lens	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.
Test 1/Control 1, then Control 2/Test 2	Contact lens with investigational coating 1	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.
Test 1/Control 1, then Control 2/Test 2	Contact lens with investigational coating 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.
Control 1/Test 1, then Test 2/Control 2	Contact lens with investigational coating 1	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.
Control 1/Test 1, then Test 2/Control 2	OPTI-FREE® RepleniSH® MPDS	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.
Control 2/Test 2, then Test 1/Control 1	OPTI-FREE® RepleniSH® MPDS	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.
Test 1/Control 1, then Control 2/Test 2	OPTI-FREE® RepleniSH® MPDS	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.
Test 2/Control 2, then Control 1/Test 1	OPTI-FREE® RepleniSH® MPDS	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.
Control 2/Test 2, then Test 1/Control 1	Contact lens with investigational coating 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.
Control 1/Test 1, then Test 2/Control 2	Balafilcon A contact lens	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.
Control 1/Test 1, then Test 2/Control 2	Contact lens with investigational coating 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.
Control 2/Test 2, then Test 1/Control 1	Contact lens with investigational coating 2	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.
Test 2/Control 2, then Control 1/Test 1	Contact lens with investigational coating 2	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.
Control 2/Test 2, then Test 1/Control 1	Balafilcon A contact lens	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.

Primary Outcome Measures

Name	Time	Method
Average Percent Area of Solution-related Corneal Staining	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.

Secondary Outcome Measures