7-Day, Multi-Site Study of an Investigational Multi-Purpose Disinfecting Solution for Contact Lens Wearers

Alcon

Status: Completed

Conditions: Contact Lens Care

Treatments: Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS); Device: Balafilcon A contact lens (PureVision®); Device: Lotrafilcon B contact lens (O2 OPTIX®); Device: Senofilcon A contact lens (ACUVUE® OASYS™); Device: Etafilcon A contact lens (ACUVUE® 2™)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00884806

C-08-081

Details and patient eligibility

About

The purpose of this study is to clinically evaluate solution-related corneal staining with an investigational multi-purpose disinfecting solution (MPDS) in hydrogel and silicone hydrogel contact lens wearers.

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age or older.
• Wear contact lenses a minimum of 8 hours per day for at least 7-10 days prior to Visit 1 (screening visit).
• Vision correctable to 20/30 (Snellen) or better in each eye at distance with contact lenses at Visit 1.
• Must discontinue contact lens wear for at least two consecutive days before Visit 2 (baseline visit).
• Other protocol-specified 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 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: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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110 participants in 1 patient group

FID 114675A

Experimental group

Description:

FID 114675A used for 7 days, per protocol-specified instructions. Silicone hydrogel or hydrogel contact lenses worn bilaterally on a daily wear basis, one brand only.

Treatment:

Device: Etafilcon A contact lens (ACUVUE® 2™)

Device: Lotrafilcon B contact lens (O2 OPTIX®)

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

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

Device: Balafilcon A contact lens (PureVision®)