Three Daily Wear Monthly Replacement Silicone Hydrogel Contact Lenses With Two Multi-purpose Disinfecting Solution Combinations

Alcon

Status: Completed

Conditions: Refractive Errors

Treatments: Device: LID018869+RepleniSH; Device: Biofinity+RepleniSH; Device: LID018869+Biotrue; Device: PV+Biotrue

Study type: Interventional

Funder types: Industry

Identifiers

NCT04789382

CLY935-E007

Details and patient eligibility

About

The purpose of this study is to evaluate corneal staining observed after 2 hours of wear with an investigational contact lens against both PureVision contact lenses pre-cycled with Biotrue and Biofinity contact lenses pre-cycled with RepleniSH.

Full description

Subjects will be randomized in a 1:1:1:1 manner to receive one of 4 regimen sequences with lens and multipurpose disinfection solution (MPDS) combinations. The expected duration of subject participation in the study is approximately 1 week with 2 study visit days.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Understand and sign an Informed Consent;
• Successful wear 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 of less than or equal to 1.50 diopter (D) in each eye;
• Best corrected visual acuity (BCVA) better than or equal to 20/25 Snellen in each eye;
• Willing to stop wearing habitual contact lenses for the duration of study lens exposure and during the washout period.
• Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

• Any eye condition or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator;
• Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
• Eye surgery, as specified in the protocol;
• Dry eye; use of artificial tears, as specified in the protocol;
• Other protocol-specified exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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36 participants in 4 patient groups

Sequence 1

Other group

Description:

LID018869+RepleniSH in the right eye and Biofinity+RepleniSH in the left eye (first wear period), followed by PV+Biotrue in the right eye and LID018869+Biotrue in the left eye (second wear period). Each wear period will be 2 hours.

Treatment:

Device: Biofinity+RepleniSH

Device: LID018869+Biotrue

Device: PV+Biotrue

Device: LID018869+RepleniSH

Sequence 2

Other group

Description:

Biofinity+RepleniSH in the right eye and LID018869+RepleniSH in the left eye (first wear period), followed by LID018869+Biotrue in the right eye and PV+Biotrue in the left eye (second wear period). Each wear period will be 2 hours.

Treatment:

Device: Biofinity+RepleniSH

Device: LID018869+Biotrue

Device: PV+Biotrue

Device: LID018869+RepleniSH

Sequence 3

Other group

Description:

LID018869+Biotrue in the right eye and PV+Biotrue in the left eye (first wear period), followed by Biofinity+RepleniSH in the right eye and LID018869+RepleniSH in the left eye (second wear period). Each wear period will be 2 hours.

Treatment:

Device: Biofinity+RepleniSH

Device: LID018869+Biotrue

Device: PV+Biotrue

Device: LID018869+RepleniSH

Sequence 4

Other group

Description:

PV+Biotrue in the right eye and LID018869+Biotrue in the left eye (first wear period), followed by LID018869+RepleniSH in the right eye and Biofinity+RepleniSH the left eye (second wear period). Each wear period will be 2 hours.

Treatment:

Device: Biofinity+RepleniSH

Device: LID018869+Biotrue

Device: PV+Biotrue

Device: LID018869+RepleniSH