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

NCT ID: NCT00885092

Last Updated: 2012-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2009-05-31

Brief Summary

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.

Conditions

Contact Lens Care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

FID 114675A / RepleniSH

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.

Group Type: OTHER

FID 114675A Multi-Purpose Disinfecting Solution (MPDS)

Intervention Type: DEVICE

Investigational solution intended for use as a cleaning, rinsing, conditioning, disinfecting, and storage solution for silicone hydrogel (SiH) contact lenses.

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

Intervention Type: DEVICE

Commercially marketed solution intended for use as a cleaning, conditioning, rinsing, disinfecting, and storage solution for all silicone hydrogel and soft (hydrophilic) contact lenses.

Senofilcon A contact lens (ACUVUE® Oasys™)

Intervention Type: DEVICE

Commercially marketed silicone hydrogel contact lens for daily wear use

Balafilcon A contact lens (PureVision®)

Intervention Type: DEVICE

Commercially marketed silicone hydrogel contact lens for daily wear use

RepleniSH / FID 114675A

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.

Group Type: OTHER

FID 114675A Multi-Purpose Disinfecting Solution (MPDS)

Intervention Type: DEVICE

Investigational solution intended for use as a cleaning, rinsing, conditioning, disinfecting, and storage solution for silicone hydrogel (SiH) contact lenses.

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

Intervention Type: DEVICE

Commercially marketed solution intended for use as a cleaning, conditioning, rinsing, disinfecting, and storage solution for all silicone hydrogel and soft (hydrophilic) contact lenses.

Senofilcon A contact lens (ACUVUE® Oasys™)

Intervention Type: DEVICE

Commercially marketed silicone hydrogel contact lens for daily wear use

Balafilcon A contact lens (PureVision®)

Intervention Type: DEVICE

Commercially marketed silicone hydrogel contact lens for daily wear use

Interventions

FID 114675A Multi-Purpose Disinfecting Solution (MPDS)

Investigational solution intended for use as a cleaning, rinsing, conditioning, disinfecting, and storage solution for silicone hydrogel (SiH) contact lenses.

Intervention Type: DEVICE

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

Commercially marketed solution intended for use as a cleaning, conditioning, rinsing, disinfecting, and storage solution for all silicone hydrogel and soft (hydrophilic) contact lenses.

Intervention Type: DEVICE

Senofilcon A contact lens (ACUVUE® Oasys™)

Commercially marketed silicone hydrogel contact lens for daily wear use

Intervention Type: DEVICE

Balafilcon A contact lens (PureVision®)

Commercially marketed silicone hydrogel contact lens for daily wear use

Intervention Type: DEVICE

Other Intervention Names

(OPTI-FREE® RepleniSH®); ACUVUE® Oasys™; PureVision®

Eligibility Criteria

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).

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

C-08-082

Identifier Type: -

Identifier Source: org_study_id