search
Back to results

Evaluation of Two Different Designs of Bausch & Lomb Contact Lenses

Primary Purpose

Myopia

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

About this trial

This is an interventional basic science trial for Myopia focused on measuring contact lens

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects must have clear central corneas and be free of any anterior segment disorders.
  • Subjects must be adapted wearers of one of the listed contact lenses
  • Subjects must be myopic
  • Subjects must use a lens care system on a regular basis.

Exclusion Criteria:

  • Subjects who have worn gas permeable (GP) contact lenses within the last 30 days of polymethylmethacrylate (PMMA) lenses within the last 3 months.
  • Subjects with any systemic disease affecting ocular health.
  • Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
  • Subjects with an active ocular disease or are using any ocular medication.
  • Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
  • Subjects who have had any corneal surgery (eg, refractive surgery).
  • Subjects who have participated in any drug or device clinical investigation within two weeks prior to entry into this study and/or during the period of study participation.

Sites / Locations

  • Bausch & Lomb

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Redesigned Purevision Contact Lens

PureVision Contact Lens

Arm Description

Redesigned Bausch & Lomb PureVision contact lens

Bausch & Lomb PureVision contact lens

Outcomes

Primary Outcome Measures

Symptoms and Complaints
Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints and 100 denoting the most favorable rating. The generic scale was comprised of 14 separate questions, where each assessed the denoted symptom/complaint with a score between 0 and 100. The total score was not calculated.

Secondary Outcome Measures

Visual Acuity
Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).
Percentage of Eyes With > Grade 2 Slit Lamp Findings
Graded slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). The outcome measure is any finding > grade 2, across abnormalities.

Full Information

First Posted
April 30, 2010
Last Updated
September 11, 2020
Sponsor
Bausch & Lomb Incorporated
search

1. Study Identification

Unique Protocol Identification Number
NCT01118338
Brief Title
Evaluation of Two Different Designs of Bausch & Lomb Contact Lenses
Official Title
A Study to Evaluate the Product Performance of Two Different Designs of Bausch & Lomb PureVision® Contact Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
July 2010 (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
The objective of this one month study is to evaluate the product performance of a redesigned PureVision Contact Lens compared to the PureVision Contact Lens when worn on a daily wear basis by wearers of contact lenses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
contact lens

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
376 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Redesigned Purevision Contact Lens
Arm Type
Experimental
Arm Description
Redesigned Bausch & Lomb PureVision contact lens
Arm Title
PureVision Contact Lens
Arm Type
Active Comparator
Arm Description
Bausch & Lomb PureVision contact lens
Intervention Type
Device
Intervention Name(s)
Redesigned Purevision Contact Lens
Intervention Description
Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month.
Intervention Type
Device
Intervention Name(s)
PureVision Contact Lens
Intervention Description
Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month.
Primary Outcome Measure Information:
Title
Symptoms and Complaints
Description
Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints and 100 denoting the most favorable rating. The generic scale was comprised of 14 separate questions, where each assessed the denoted symptom/complaint with a score between 0 and 100. The total score was not calculated.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Visual Acuity
Description
Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).
Time Frame
1 month
Title
Percentage of Eyes With > Grade 2 Slit Lamp Findings
Description
Graded slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). The outcome measure is any finding > grade 2, across abnormalities.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects must have clear central corneas and be free of any anterior segment disorders. Subjects must be adapted wearers of one of the listed contact lenses Subjects must be myopic Subjects must use a lens care system on a regular basis. Exclusion Criteria: Subjects who have worn gas permeable (GP) contact lenses within the last 30 days of polymethylmethacrylate (PMMA) lenses within the last 3 months. Subjects with any systemic disease affecting ocular health. Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance. Subjects with an active ocular disease or are using any ocular medication. Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear. Subjects who have had any corneal surgery (eg, refractive surgery). Subjects who have participated in any drug or device clinical investigation within two weeks prior to entry into this study and/or during the period of study participation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerard Cairns, MCOptom, PhD
Organizational Affiliation
Bausch & Lomb Incorporated
Official's Role
Study Director
Facility Information:
Facility Name
Bausch & Lomb
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Two Different Designs of Bausch & Lomb Contact Lenses

We'll reach out to this number within 24 hrs