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

NCT ID: NCT00884806

Last Updated: 2012-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2009-06-30

Brief Summary

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.

Conditions

Contact Lens Care

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

FID 114675A

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.

Group Type: EXPERIMENTAL

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

Etafilcon A contact lens (ACUVUE® 2™)

Intervention Type: DEVICE

Commercially marketed hydrogel contact lens for daily wear use

Senofilcon A contact lens (ACUVUE® OASYS™)

Intervention Type: DEVICE

Commercially marketed silicone hydrogel contact lens for daily wear use

Lotrafilcon B contact lens (O2 OPTIX®)

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

Etafilcon A contact lens (ACUVUE® 2™)

Commercially marketed hydrogel contact lens for daily wear use

Intervention Type: DEVICE

Senofilcon A contact lens (ACUVUE® OASYS™)

Commercially marketed silicone hydrogel contact lens for daily wear use

Intervention Type: DEVICE

Lotrafilcon B contact lens (O2 OPTIX®)

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

ACUVUE® 2™; ACUVUE® OASYS™; O2 OPTIX®; PureVision®

Eligibility Criteria

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).

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.

• 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-08-081

Identifier Type: -

Identifier Source: org_study_id