NCT03034928

Clinical Biocompatibility Evaluation of Contact Lens Coatings

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to evaluate corneal staining observed after 2 hours of wear with contact lenses with investigational coating against PureVision™ lenses, all pre-cycled with OPTI-FREE® RepleniSH® multi-purpose disinfection solution.

Detailed description

In this contralateral crossover study, qualifying subjects will wear a total of 2 pairs of study contact lenses. Lenses will be worn according to a randomized lens sequence assignment. Each pair will consist of a test lens (Test 1 or Test 2) and a control lens.

Conditions

• Refractive Errors
• Ametropia

Interventions

Type	Name	Description
DEVICE	Contact lens with investigational coating 1	Contact lens with investigational coating 1 pre-cycled in OPTI-FREE® RepleniSH® Multi-Purpose Disinfecting Solution (MPDS)
DEVICE	Balafilcon A contact lens	Balafilcon A contact lens pre-cycled OPTI-FREE® RepleniSH® MPDS
DEVICE	OPTI-FREE® RepleniSH® MPDS	Multipurpose contact lens solution
DEVICE	Contact lens with investigational coating 2	Contact lens with investigational coating 2 pre-cycled in OPTI-FREE® RepleniSH® MPDS

Timeline

• Start date: 2017-02-14
• Primary completion: 2017-03-14
• Completion: 2017-03-14
• First posted: 2017-01-27
• Last updated: 2020-02-18
• Results posted: 2020-02-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study