Product Performance of a Toric Contact Lens
A Study to Evaluate the Product Performance of a Prism-Ballasted Toric Contact Lens When Worn by Currently Adapted Soft Contact Lens Wearers.
1 other identifier
interventional
220
1 country
1
Brief Summary
Product performance of a Bausch \& Lomb Toric Contact Lens compared to Ciba Vision Focus Daily Toric Contact Lens
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2008
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 12, 2008
CompletedFirst Posted
Study publicly available on registry
April 16, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedResults Posted
Study results publicly available
February 16, 2011
CompletedDecember 12, 2011
December 1, 2011
2 months
April 12, 2008
December 14, 2010
December 7, 2011
Conditions
Outcome Measures
Primary Outcomes (2)
Symptoms and Complaints
1-100 Scale for each eye. Zero represented the least favorable rating and 100 represented the most favorable.
Over-all follow-up visits for 2 week period
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.
Over-all follow-up visits, 2 weeks
Secondary Outcomes (1)
Slit Lamp Findings
Over-all follow-up visits, 2 weeks
Study Arms (2)
SofLens DD Toric
EXPERIMENTALBausch \& Lomb SofLens Daily Disposable Toric Contact Lens
Ciba Vision Toric Lens
ACTIVE COMPARATORCiba Vision Focus Dailies Toric Contact Lens
Interventions
daily disposable wear contact lens for 2 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Laser Focus Sdn Bhd, Vision Correction Centre
Johor Bahru, 80400, Malaysia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Cairns, PhD, MCOptom
- Organization
- Bausch & Lomb Incorporated
Study Officials
- STUDY DIRECTOR
Gerard Cairns, PhD,MCOptom
Bausch & Lomb Incorporated
- PRINCIPAL INVESTIGATOR
Benny Chian, MCOptom,DO
Laser Focus Sdn Bhd, Vision Correction Centre
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2008
First Posted
April 16, 2008
Study Start
April 1, 2008
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
December 12, 2011
Results First Posted
February 16, 2011
Record last verified: 2011-12