NCT01629706

Determination of Cell Population in Solution-Induced Corneal Staining (SICS) and Symptomatic Versus Asymptomatic Lens Wearers

Determination of Cell Population in SICS and Symptomatic Versus Asymptomatic Lens Wearers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: CIBA VISION · Industry
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to investigate the corneal epithelial cell response associated with lens wear that results in solution-induced corneal staining (Phase1) and to determine the cell appearance in symptomatic and asymptomatic contact lens wearers (Phase 2).

Detailed description

This study consisted of 2 phases. In Phase 1, participants wore contact lenses pre-soaked overnight in contact lens solution for 2 hours and 4 hours, separate days. A minimum of 7 days separated the wear periods. Ocular surface cells were collected after both wear periods. In Phase 2, participants wore their habitual contact lenses on a daily wear basis for 4 weeks with habitual lens care. Ocular surface cells were collected after Day 1 and Day 28. Phase 2 included eligible participants who completed Phase 1 and new participants. A participant was considered to be asymptomatic if he/she can typically wear contact lenses comfortably for at least 10 hours/day a minimum of 5 days/week, and symptomatic if he/she typically wears contact lenses for a minimum of 3 days/week and experiences ocular discomfort after less than 6 hours of wear. Phase 1 participants not eligible to participate in Phase 2 or uninterested in continuing into Phase 2 were exited from the study.

Conditions

• Refractive Error
• Dry Eye

Interventions

Type	Name	Description
DEVICE	Balafilcon A contact lens	Commercially marketed silicone hydrogel contact lens
DEVICE	Habitual contact lenses	Commercially marketed silicone hydrogel contact lenses as prescribed by eye care practitioner, brand and power
DEVICE	Renu multi-purpose solution	Commercially marketed solution for use in removing protein, cleaning, conditioning, and disinfecting contact lenses.
DEVICE	ClearCare	Commercially marketed hydrogen peroxide system for cleaning and disinfecting contact lenses
DEVICE	Habitual lens care	Lens care per habitual use

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2012-06-28
• Last updated: 2015-03-03
• Results posted: 2015-02-13