Effect of FID 114675A on Lens Wettability

• FID 114675A multi-purpose disinfecting solution (MPDS) (Device): Investigational multi-purpose disinfecting solution intended for use as a cleaning, reconditioning, rinsing, disinfecting, and storage solution for silicone hydrogel and soft contact lenses.
• Soft contact lens (Device), also known as Acuvue2, PureVision, Acuvue Oasys: Soft hydrogel or silicone hydrogel contact lens matching subject's pre-study lens, including parameters, worn 16 hours on day of dispense.
• Blister pack solution (Device), also known as Acuvue2, PureVision, Acuvue Oasys: Commercially approved storage solution as found in the contact lens blister pack.

Primary outcomes

• Lens Wettability [16 hours]: As assessed by the investigator during slit-lamp exam and rated on a 0-4 scale, with 0 = a smooth uniformly reflecting wettable surface; 1 = a coarse hazy wettable surface which seems resolved momentarily with each blink and becomes exacerbated with staring; 2 = one stable dry (non-wetting) area of some magnitude; 3 = more than one stable dry (non-wetting) area of some magnitude; 4 = non-wettable lens surface of severe magnitude. Lenses with a Grade 0 or 1 were rated as wettable and reported as a percentage of total lenses evaluated.

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* 18 years or age or older with normal eyes, other than correction for refractive error.
* At least 5 days successful daily wear (minimum 8 hours per day) of PureVision®, Acuvue® Oasys™, or Acuvue® 2 contact lenses prior to Visit 1
* Vision correctable to 20/30 (Snellen) or better in each eye at distance with lenses at Visit 1 (Day 0 - Baseline).
* Grade 0 or Grade 1 wettability in both eyes after at least 15 minutes of lens wear at Visit 1 (Day 0 - Baseline).
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the test articles or affect the results of the study.
* Need to wear contact lenses on an extended wear basis (i.e., overnight) during the study.
* Use of products other than a multi-purpose solution or hydrogen peroxide solution, including daily and enzyme cleaners and saline rinses, for lens care at least 7 days prior to Visit 1 (Day 0 - Baseline).
* Use of over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit 1. Use of lens rewetting drops is acceptable.
* History or current ocular infections or ocular inflammatory events.
* Ocular surgery within the past year.
* Participation in any investigational study within the past 30 days.
* Other protocol-defined exclusion criteria may apply.

Participant flow

Outcome results

• Lens Wettability (Primary), Number, percentage of lenses: FID 114675A 95.5 (87.3 to 99.1); Blister Pack 97.0 (89.5 to 99.6)

Adverse events

Time frame: Adverse events were collected for the duration of the study: October 11, 2010 through February 2, 2011.