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

Not Applicable

Completed

• Conditions: Contact Lens Care
• Interventions: 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®)

• Registration Number: NCT00884806
• Lead Sponsor: Alcon Research

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-04-17
• Study First Submitted QC: 2009-04-20
• Study First Posted: 2009-04-21
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Results First Submitted: 2012-02-20
• Results First Submitted QC: 2012-02-20
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-21
• Results First Posted: 2012-03-22
• Last Update Posted: 2012-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FID 114675A	Balafilcon A contact lens (PureVision®)	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.
FID 114675A	FID 114675A Multi-Purpose Disinfecting Solution (MPDS)	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.
FID 114675A	Senofilcon A contact lens (ACUVUE® OASYS™)	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.
FID 114675A	Lotrafilcon B contact lens (O2 OPTIX®)	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.
FID 114675A	Etafilcon A contact lens (ACUVUE® 2™)	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.

Primary Outcome Measures

Name	Time	Method
Solution-Related Corneal Staining	Day 7	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.

Secondary Outcome Measures

Name	Time	Method
Mean Lens Comfort	Day 7	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.