Product Performance of a Toric Contact Lens

Myopia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00658996
• Other study ID #: 559
• Status: Completed
• Phase: N/A
• First received: April 12, 2008
• Last updated: December 7, 2011
• Start date: April 2008
• Est. completion date: June 2008

Study information

• Verified date: December 2011
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Product performance of a Bausch & Lomb Toric Contact Lens compared to Ciba Vision Focus Daily Toric Contact Lens

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Astigmatism
• Myopia

Intervention

Device:
• SofLens DD Toric
daily disposable wear contact lens for 2 weeks
• Ciba Vision Focus Dailies Toric Contact Lens
daily disposable wear contact lens for 2 weeks

Locations

Country	Name	City	State
Malaysia	Laser Focus Sdn Bhd, Vision Correction Centre	Johor Bahru

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	Over-all follow-up visits, 2 weeks	No