Single Site Study of the Wettability of Contact Lenses With an Investigational Multi-Purpose Disinfecting Solution vs. a Marketed Multi-Purpose Solution

Alcon

Status: Completed

Conditions: Contact Lens Care

Treatments: Device: Balafilcon A contact lens (PureVision®); Device: RepleniSH Multi-Purpose Disinfecting Solution (MPDS) (OPTI-FREE® RepleniSH®); Device: Senofilcon A contact lens (ACUVUE® Oasys™); Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00885092

C-08-082

Details and patient eligibility

About

The purpose of this study is to clinically evaluate an investigational multi-purpose disinfecting solution (MPDS) compared to a commercial MPDS with respect to wettability of silicone hydrogel contact lenses.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age or older.
• Must be successfully wearing assigned study lens brand (either ACUVUE® OASYS™ or PureVision® contact lenses) for at least 7-10 days, minimum 8 hours a day, prior to Visit 1 (screening).
• Vision correctable to 20/30 (Snellen) or better in each eye at distance with study lenses at Visit 1 (screening).
• Must have discontinued contact lens wear for at least two consecutive days before Visit 2 (baseline).
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Any medical condition (systemic or ophthalmic) that may, in the opinion of the investigator, preclude safe administration of test article or safe participation in the study.
• Known sensitivity or intolerance to any protocol-specified contact lens solutions, eye drops, or products containing similar ingredients (e.g., generic products).
• Monocular vision (only one eye with functional vision) or fit with only one contact lens.
• Use of topical ocular over-the-counter or prescribed topical ocular medication, with the exception of rewetting drops, within 7 days prior to screening visit.
• Current or history of ocular infection, inflammation, disease, structural abnormality or conditions within the last 6 months that could affect study participation or may preclude safe administration of the investigational lens care solution, in the opinion of the investigator.
• Any corneal surgery, cataract surgery, intraocular lens implants or glaucoma filtering surgery within the last 12 months.
• Any slit-lamp finding score of 1 (or rated 3 or 4 for limbal and bulbar conjunctival injection) at screening or baseline visits.
• Corneal staining area assessment ≥ 20% in any corneal region in either eye at screening or baseline visit.
• Corneal staining graded as 2 (macropunctate) or greater in any corneal region in either eye at baseline visit.
• Participation in any investigational clinical study within 30 days of baseline visit.
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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40 participants in 2 patient groups

FID 114675A / RepleniSH

Other group

Description:

FID 114675A in Period 1; RepleniSH in Period 2. Each solution was used for 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of each period and worn bilaterally on a daily wear basis.

Treatment:

Device: Senofilcon A contact lens (ACUVUE® Oasys™)

Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS)

Device: RepleniSH Multi-Purpose Disinfecting Solution (MPDS) (OPTI-FREE® RepleniSH®)

Device: Balafilcon A contact lens (PureVision®)

RepleniSH / FID 114675A

Other group

Description:

RepleniSH in Period 1; FID 114675A in Period 2. Each solution was used for 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of each period and worn bilaterally on a daily wear basis.

Treatment:

Device: Senofilcon A contact lens (ACUVUE® Oasys™)

Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS)

Device: RepleniSH Multi-Purpose Disinfecting Solution (MPDS) (OPTI-FREE® RepleniSH®)

Device: Balafilcon A contact lens (PureVision®)