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

Corneal Staining Evaluation of SiH MPDS FID 114675A

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.

Study Overview

• Status: Completed
• Conditions: Contact Lens Care
• Intervention / Treatment: Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS); Device: Etafilcon A contact lens (ACUVUE® 2™); Device: Senofilcon A contact lens (ACUVUE® OASYS™); Device: Lotrafilcon B contact lens (O2 OPTIX®); Device: Balafilcon A contact lens (PureVision®)

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Device: 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; Device: Etafilcon A contact lens (ACUVUE® 2™); Commercially marketed hydrogel contact lens for daily wear use; Other Names: ACUVUE® 2™; Device: Senofilcon A contact lens (ACUVUE® OASYS™); Commercially marketed silicone hydrogel contact lens for daily wear use; Other Names: ACUVUE® OASYS™; Device: Lotrafilcon B contact lens (O2 OPTIX®); Commercially marketed silicone hydrogel contact lens for daily wear use; Other Names: O2 OPTIX®; Device: Balafilcon A contact lens (PureVision®); Commercially marketed silicone hydrogel contact lens for daily wear use; Other Names: PureVision®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Solution-Related Corneal Staining	Corneal staining was assessed by the investigator using fluorescein dye, a yellow filter, and a slit lamp. Corneal staining was graded on a continuous scale of 0% (no staining in the region) to 100% (staining covers entire region) in 1% increments for 5 corneal regions (central, nasal, temporal, inferior, and superior). Solution-related corneal staining was defined as ≥20% corneal staining area in at least 3 corneal regions of both eyes.	Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Lens Comfort	Lens comfort was assessed by the participant on a 5-point Likert scale prior to any examination. The participant was instructed to select a single response to the statement, "Over the previous 2-3 hours, my lenses felt comfortable," with 1 = strongly disagree, 2 = disagree, 3 = undecided, 4 = agree, and 5 = strongly agree.	Day 7

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: April 17, 2009
• First Submitted That Met QC Criteria: April 20, 2009
• First Posted (Estimate): April 21, 2009

Study Record Updates

• Last Update Posted (Estimate): March 27, 2012
• Last Update Submitted That Met QC Criteria: March 21, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Contact lenses; Disinfecting solutions
• Other Study ID Numbers: C-08-081