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N/A N=110 Supportive Care

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

Contact Lens Care

Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Mar 2012
Primary outcome: Primary: Solution-Related Corneal Staining — 0 Percentage of participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
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®) (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Alcon Research
Primary completion
Jun 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Solution-Related Corneal Staining
SECONDARY
Mean Lens Comfort
4.4

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.

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).
  • 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00884806). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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