NCT02540122

Pilot Clinical Evaluation of Approved Contact Lenses

Imaging of Conjunctival Microvasculature During Contact Lens Wear

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Johnson & Johnson Vision Care, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This is a pilot evaluation to assess the feasibility of using novel imaging process to characterize lens edge and limbal epithelial thickness profile; lens movement with gaze and blink; and conjunctival microvasculature including fractal analysis of microvascular perfusion maps and blood flow velocity.

Detailed description

This is a pilot evaluation to assess the feasibility of using ultra-high resolution optical coherence tomography (OCT) to image and characterize lens edge and limbal epithelial thickness profile; lens movement with gaze and blink; and conjunctival microvasculature including fractal analysis of microvascular perfusion maps and blood flow velocity.

Conditions

• Vision Disorders

Interventions

Type	Name	Description
DEVICE	Marketed Contact Lens 1	Marketed contact lens being worn by the subject in a bilateral fashion for approximately 6 hours (+/- 30 minutes).
DEVICE	Marketed Contact Lens 2	Marketed contact lens being worn by the subject in a bilateral fashion for approximately 6 hours (+/- 30 minutes).
DEVICE	Marketed Contact Lens 3	Marketed contact lens being worn by the subject in a bilateral fashion for approximately 6 hours (+/- 30 minutes).
DEVICE	Marketed Contact Lens 4	Marketed contact lens being worn by the subject in a bilateral fashion for approximately 6 hours (+/- 30 minutes).

Timeline

• Start date: 2015-08-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2015-09-03
• Last updated: 2017-06-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study