Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens

Not Applicable

Completed

• Conditions: Corneal Deformity
• Interventions: Device: B&L Investigational Contact Lens

• Registration Number: NCT02258139
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

This will be a randomized non-dispensing study comparing the overnight corneal swelling of an eye while wearing no contact lens to the Ultra contract lens.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-03
• Study First Submitted QC: 2014-10-06
• Study First Posted: 2014-10-07
• Study Start: 2014-11-03
• Primary Completion: 2014-12-11
• Study Completion: 2014-12-11
• Results First Submitted: 2020-08-21
• Status Verified: 2020-09
• Results First Submitted QC: 2020-09-11
• Last Update Submitted: 2020-09-11
• Results First Posted: 2020-09-14
• Last Update Posted: 2020-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Be between 18 and 40 years of age (inclusive)
• Not a current contact lens wearer (have not worn extended wear, and not worn in lenses in 6 months)
• Able to read, comprehend and sign an informed consent
• Willing to comply with the wear and study visit schedule
• Monocular best-corrected distance visual acuity >/-20/25 in each eye

Exclusion Criteria

• Any active corneal infection, disease, injury, inflammation, past surgery, or ocular abnormality which may interfere with contact lens wear
• Systemic or ocular allergies, which might interfere with contact lens wear
• Systemic disease or condition, which might interfere with contact lens wear
• Use of prescription sleep aids or alcohol within 24 hours of study appointment
• Inability to wear contact lenses
• Under 18 years of age

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Group 1	B&L Investigational Contact Lens	1st overnight visit with no contact lens; 2nd overnight visit randomized to either left or right eye for B\&L Investigational Contact Lens

Primary Outcome Measures

Name	Time	Method
Percent Change in Central Corneal Thickness	8 hours	Percent change in central corneal thickness from evening to morning (after 8 hours with lid closed)

Secondary Outcome Measures

Name	Time	Method
Time to Restore Central Corneal Thickness	48 hours	Time (hours) to restore central corneal thickness to its baseline value after lens removal

Trial Locations

Locations (1)

Indiana University; 🇺🇸 Bloomington, Indiana, United States