Assessment of Tear Film-Based Proteins Associated With Care Solution Induced Corneal Staining

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01100424
First received: April 7, 2010
Last updated: October 19, 2012
Last verified: July 2012
  Purpose

The purpose of this study was to investigate the association of inflammatory mediators found in the tear film during the development and following the induction of contact lens solution-induced corneal staining.


Condition Intervention
Corneal Staining
Device: Opti-Free RepleniSH
Device: ReNu MultiPlus
Device: Balafilcon A
Other: Unisol 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Assessment of Tear Film-Based Proteins Associated With Care Solution Induced Corneal Staining

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Tear Protein Expression [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Corneal Staining [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: March 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Contact lens wearers
Contact lens wearers experienced three currently available contact lens/contact lens care combinations in randomized order: balafilcon A + Optifree RepleniSH, balafilcon A + ReNu MultiPlus, and balafilcon A + Unisol 4 saline.
Device: Opti-Free RepleniSH
Commercially available contact lens solution used for pre-soaking balafilcon A contact lenses overnight prior to lens insertion.
Device: ReNu MultiPlus
Commercially available contact lens solution used for pre-soaking balafilcon A contact lenses overnight prior to lens insertion.
Other Name: Renu
Device: Balafilcon A
Commercially available silicone hydrogel contact lenses removed from blister pack and soaked overnight in Opti-Free Replenish, ReNu MultiPlus, or Unisol 4, then applied to the eye and worn for 2 hours.
Other Name: PureVision
Other: Unisol 4
Commercially available non preserved sterile saline solution used for pre-soaking balafilcon A contact lenses overnight prior to lens insertion.
No Intervention: Non-lens wearers
Non-lens wearers completed one study visit and served as the control group.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

For non-lens wearers:

  • Normal eyes.
  • Currently not wearing contact lenses and has not worn contact lenses for the previous 6 months.
  • Free of dry eye using the Ocular Surface Disease Index (Schiffman et al).
  • Other protocol-defined inclusion criteria may apply.

For contact lens wearers:

  • Currently wearing soft contact lenses.
  • Free of dry eye during lens wear using the Contact Lens Dry Eye Questionnaire Short-Form (Nichols et al, Cornea, 2002).
  • Reports a contact lens wearing time of at least 12 hours per day, 7 days per week, daily wear basis (not overnight wear).
  • Reports only occasional use of contact lens rewetting drops or artificial tears.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

For non-lens wearers and contact lens wearers:

  • Pregnant.
  • Participating in another research study.
  • Exhibiting staining with fluorescein in more than 5% of the total cornea (graded by "extent" of staining across 5 regions).
  • 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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01100424

Locations
United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Jami Kern Alcon, Ltd.
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01100424     History of Changes
Other Study ID Numbers: SMA-09-20
Study First Received: April 7, 2010
Last Updated: October 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
Contact lenses
Contact lens solution
Corneal staining

Additional relevant MeSH terms:
Contact Lens Solutions
Disinfectants
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014