Clinical Biocompatibility Evaluation of Contact Lens Coatings

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.

• Contact lens with investigational coating 1 (Device), also known as Test 1: Contact lens with investigational coating 1 pre-cycled in OPTI-FREE® RepleniSH® Multi-Purpose Disinfecting Solution (MPDS)
• Balafilcon A contact lens (Device), also known as Bausch & Lomb PureVision™, Control 1, Control 2: Balafilcon A contact lens pre-cycled OPTI-FREE® RepleniSH® MPDS
• OPTI-FREE® RepleniSH® MPDS (Device): Multipurpose contact lens solution
• Contact lens with investigational coating 2 (Device), also known as Test 2: Contact lens with investigational coating 2 pre-cycled in OPTI-FREE® RepleniSH® MPDS

Primary outcomes

• 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.

Sex: All, ages: 18 Years to any

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.

Participant flow

Outcome results

• Average Percent Area of Solution-related Corneal Staining (Primary), Mean, percentage of area: Test 1 7.01 +/- 10.54; Control 1 12.82 +/- 17.93; Test 2 13.54 +/- 17.20; Control 2 7.58 +/- 10.34

Adverse events

Time frame: Baseline through study completion, approximately 8 days

• Study Protocol (PDF, 2016-12-09)
• Statistical Analysis Plan (PDF, 2017-01-05)

• Sr. Clinical Manager, Trial Management Operations, Study director, Alcon, A Novartis Division