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

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

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.

Study Overview

• Status: Completed
• Conditions: Corneal Deformity
• Intervention / Treatment: Device: B&L Investigational Contact Lens

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Bloomington, Indiana, United States, 47405
      • Indiana University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Group 1; 1st overnight visit with no contact lens; 2nd overnight visit randomized to either left or right eye for B&L Investigational Contact Lens	Device: B&L Investigational Contact Lens; The lens used in this study will be supplied by the Sponsor. All subjects will wear a -3.00D lens.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change in Central Corneal Thickness	Percent change in central corneal thickness from evening to morning (after 8 hours with lid closed)	8 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Restore Central Corneal Thickness	Time (hours) to restore central corneal thickness to its baseline value after lens removal	48 hours

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated
• Investigators: Study Director: Robert Steffen, OD, MS, Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2014
• Primary Completion (Actual): December 11, 2014
• Study Completion (Actual): December 11, 2014

Study Registration Dates

• First Submitted: October 3, 2014
• First Submitted That Met QC Criteria: October 6, 2014
• First Posted (Estimate): October 7, 2014

Study Record Updates

• Last Update Posted (Actual): September 14, 2020
• Last Update Submitted That Met QC Criteria: September 11, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: 14-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No