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OpenTrials
Completed

NCT Number: NCT01100424

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

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.

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Key information

Conditions

Corneal Staining

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

OPTI-FREE RepleniSH

Device

Commercially available contact lens solution used for pre-soaking balafilcon A contact lenses overnight prior to lens insertion.

ReNu MultiPlus

Device

Commercially available contact lens solution used for pre-soaking balafilcon A contact lenses overnight prior to lens insertion.

Other names: Renu

balafilcon A

Device

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 names: PureVision

Unisol 4

Other

Commercially available non preserved sterile saline solution used for pre-soaking balafilcon A contact lenses overnight prior to lens insertion.

Primary outcomes

  1. Tear Protein Expression

    Time frame: 1 day

Secondary outcomes

  1. Corneal Staining

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 9, 2010
Registry last updated
Oct 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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