Clinical Biocompatibility Evaluation of Contact Lens Coatings

Alcon

Status: Completed

Conditions: Refractive Errors; Ametropia

Treatments: Device: Contact lens with investigational coating 1; Device: OPTI-FREE® RepleniSH® MPDS; Device: Balafilcon A contact lens; Device: Contact lens with investigational coating 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT03034928

CLY935-E002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

33 participants in 4 patient groups

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

Other group

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.

Treatment:

Device: Contact lens with investigational coating 2

Device: OPTI-FREE® RepleniSH® MPDS

Device: Balafilcon A contact lens

Device: Contact lens with investigational coating 1

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

Other group

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.

Treatment:

Device: Contact lens with investigational coating 2

Device: OPTI-FREE® RepleniSH® MPDS

Device: Balafilcon A contact lens

Device: Contact lens with investigational coating 1

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

Other group

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.

Treatment:

Device: Contact lens with investigational coating 2

Device: OPTI-FREE® RepleniSH® MPDS

Device: Balafilcon A contact lens

Device: Contact lens with investigational coating 1

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

Other group

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.

Treatment:

Device: Contact lens with investigational coating 2

Device: OPTI-FREE® RepleniSH® MPDS

Device: Balafilcon A contact lens

Device: Contact lens with investigational coating 1