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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00884806
First received: April 17, 2009
Last updated: March 21, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Contact Lens Care
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
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Corneal Staining Evaluation of SiH MPDS FID 114675A

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Solution-Related Corneal Staining [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
    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:
  • Mean Lens Comfort [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
    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.


Enrollment: 110
Study Start Date: March 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: ACUVUE® 2™
Device: Senofilcon A contact lens (ACUVUE® OASYS™)
Commercially marketed silicone hydrogel contact lens for daily wear use
Other Name: ACUVUE® OASYS™
Device: Lotrafilcon B contact lens (O2 OPTIX®)
Commercially marketed silicone hydrogel contact lens for daily wear use
Other Name: O2 OPTIX®
Device: Balafilcon A contact lens (PureVision®)
Commercially marketed silicone hydrogel contact lens for daily wear use
Other Name: PureVision®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00884806     History of Changes
Other Study ID Numbers: C-08-081
Study First Received: April 17, 2009
Results First Received: February 20, 2012
Last Updated: March 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
Contact lenses
Disinfecting solutions

Additional relevant MeSH terms:
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014