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Product Performance of a Toric Contact Lens

Primary Purpose

Myopia, Astigmatism

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
SofLens DD Toric
Ciba Vision Focus Dailies Toric Contact Lens
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Myopia

Eligibility Criteria

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

Inclusion Criteria:

  • Subject is an adapted soft contact lens wearer with astigmatism of 0.50 Diopter or greater
  • Visual acuity (VA) correctable to 0.3 logMar or better (driving vision)
  • Clear central cornea

Exclusion Criteria:

  • Systemic disease affecting ocular health
  • Using systemic or topical medications
  • Wears monovision or multifocal contact lenses
  • Any grade 2 or greater slit lamp findings
  • Adapted wearer of Ciba Focus Dailies Toric lens upon study entry

Sites / Locations

  • Laser Focus Sdn Bhd, Vision Correction Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SofLens DD Toric

Ciba Vision Toric Lens

Arm Description

Bausch & Lomb SofLens Daily Disposable Toric Contact Lens

Ciba Vision Focus Dailies Toric Contact Lens

Outcomes

Primary Outcome Measures

Symptoms and Complaints
1-100 Scale for each eye. Zero represented the least favorable rating and 100 represented the most favorable.
Contact Lens High Contrast Visual Acuity
VA measures at each scheduled visit were averaged to obtain an overall measure for each eye. A non-inferiority upper bound of 0.06 (3 letters) were used to assess the difference (Test - Control) in overall logMAR VA.

Secondary Outcome Measures

Slit Lamp Findings
Graded 0-4 where 0=none and 4=severe on measure of epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates

Full Information

First Posted
April 12, 2008
Last Updated
December 7, 2011
Sponsor
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT00658996
Brief Title
Product Performance of a Toric Contact Lens
Official Title
A Study to Evaluate the Product Performance of a Prism-Ballasted Toric Contact Lens When Worn by Currently Adapted Soft Contact Lens Wearers.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (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
Product performance of a Bausch & Lomb Toric Contact Lens compared to Ciba Vision Focus Daily Toric Contact Lens

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Astigmatism

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SofLens DD Toric
Arm Type
Experimental
Arm Description
Bausch & Lomb SofLens Daily Disposable Toric Contact Lens
Arm Title
Ciba Vision Toric Lens
Arm Type
Active Comparator
Arm Description
Ciba Vision Focus Dailies Toric Contact Lens
Intervention Type
Device
Intervention Name(s)
SofLens DD Toric
Intervention Description
daily disposable wear contact lens for 2 weeks
Intervention Type
Device
Intervention Name(s)
Ciba Vision Focus Dailies Toric Contact Lens
Intervention Description
daily disposable wear contact lens for 2 weeks
Primary Outcome Measure Information:
Title
Symptoms and Complaints
Description
1-100 Scale for each eye. Zero represented the least favorable rating and 100 represented the most favorable.
Time Frame
Over-all follow-up visits for 2 week period
Title
Contact Lens High Contrast Visual Acuity
Description
VA measures at each scheduled visit were averaged to obtain an overall measure for each eye. A non-inferiority upper bound of 0.06 (3 letters) were used to assess the difference (Test - Control) in overall logMAR VA.
Time Frame
Over-all follow-up visits, 2 weeks
Secondary Outcome Measure Information:
Title
Slit Lamp Findings
Description
Graded 0-4 where 0=none and 4=severe on measure of epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates
Time Frame
Over-all follow-up visits, 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is an adapted soft contact lens wearer with astigmatism of 0.50 Diopter or greater Visual acuity (VA) correctable to 0.3 logMar or better (driving vision) Clear central cornea Exclusion Criteria: Systemic disease affecting ocular health Using systemic or topical medications Wears monovision or multifocal contact lenses Any grade 2 or greater slit lamp findings Adapted wearer of Ciba Focus Dailies Toric lens upon study entry
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerard Cairns, PhD,MCOptom
Organizational Affiliation
Bausch & Lomb Incorporated
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Benny Chian, MCOptom,DO
Organizational Affiliation
Laser Focus Sdn Bhd, Vision Correction Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laser Focus Sdn Bhd, Vision Correction Centre
City
Johor Bahru
ZIP/Postal Code
80400
Country
Malaysia

12. IPD Sharing Statement

Learn more about this trial

Product Performance of a Toric Contact Lens

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