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

Primary Purpose

Corneal Deformity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
B&L Investigational Contact Lens
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Corneal Deformity

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Indiana University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study Group 1

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 3, 2014
Last Updated
September 11, 2020
Sponsor
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT02258139
Brief Title
Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens
Official Title
The Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
November 3, 2014 (Actual)
Primary Completion Date
December 11, 2014 (Actual)
Study Completion Date
December 11, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Deformity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Group 1
Arm Type
Experimental
Arm Description
1st overnight visit with no contact lens; 2nd overnight visit randomized to either left or right eye for B&L Investigational Contact Lens
Intervention Type
Device
Intervention Name(s)
B&L Investigational Contact Lens
Intervention Description
The lens used in this study will be supplied by the Sponsor. All subjects will wear a -3.00D lens.
Primary Outcome Measure Information:
Title
Percent Change in Central Corneal Thickness
Description
Percent change in central corneal thickness from evening to morning (after 8 hours with lid closed)
Time Frame
8 hours
Secondary Outcome Measure Information:
Title
Time to Restore Central Corneal Thickness
Description
Time (hours) to restore central corneal thickness to its baseline value after lens removal
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Steffen, OD, MS
Organizational Affiliation
Bausch & Lomb Incorporated
Official's Role
Study Director
Facility Information:
Facility Name
Indiana University
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47405
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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