Comparative Performance of PureVision Lens Designs

Myopia Clinical Trial

Official title:

A Study to Evaluate the Product Performance of the Redesigned Bausch & Lomb PureVision® Contact Lens (Test) Compared to the Currently Marketed Bausch & Lomb PureVision® Contact Lens (Control) When Worn on an Extended Wear Basis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00661687
• Other study ID #: 544
• Status: Completed
• Phase: Phase 3
• First received: April 16, 2008
• Last updated: December 7, 2011
• Start date: December 2007
• 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: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate the performance of the PureVision Lens designs when worn on a 30-day continuous wear basis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: June 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• subject is myopic

• 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

• wear monovision, multifocal or toric contact lenses

• Any grade 2 or greater slit lamp findings

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Currently Marketed PureVision Contact Lens.
Contact lens for continuous wear
• Alternate Design of the PureVision Contact Lens.
Contact lens for continuous wear

Locations

Country	Name	City	State
Malaysia	Laser Focus Sdn Bhd, Vision Correction Centre	Johor Bahru
Philippines	Asian Eye Institute	Makati City

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Countries where clinical trial is conducted

Malaysia,  Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective Responses to Symptoms/Complaints	Subjective responses to symptoms/complaints on a scale 0-100, where 100 is the most favorable score. Subjects rated various aspects of lens comfort, vision, and handling. The average of each symptom/complaint over all follow-up visits was assessed as the primary endpoint.	Measured at screening/dispensing visit, 1 day, 1 week and 1 month follow-up visits	No
Secondary	LogMAR Visual Acuity	The mean distance high contrast LogMAR visual acuity (VA) score for test eyes over all visits, determined by the total number of letters correctly identified on the logMAR chart.	Mean over all visits - 1 day, 1 week, 1 month	No
Secondary	Lens Characteristics	Investigators evaluated study lenses, while on eye, for the number of eyes showing 100% wettability, no discoloration, none-light deposits, fully centered centration, and adequate movement.	Over all scheduled visits day 1 - 1 month	No