A Study to Evaluate the Safety and Efficacy of a New Silicone Hydrogel Contact Lens Design

Myopia Clinical Trial

Official title:

A Study to Evaluate the Safety and Efficacy of a New Silicone Hydrogel Contact Lens Design

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01449526
• Other study ID #: 661
• Status: Completed
• Phase: N/A
• First received: October 6, 2011
• Last updated: February 13, 2015
• Start date: August 2011
• Est. completion date: January 2012

Study information

• Verified date: February 2015
• 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 safety and efficacy of a new silicone hydrogel contact lens compared to the Bausch + Lomb PureVision contact lens when worn by adapted soft contact lens wearers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: January 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Subjects must have clear central corneas and be free of any anterior segment disorders.

• Subjects must be myopic, and wear contact lenses in each eye.

• Subjects must be adapted soft contact lens wearers and agree to wear their study lenses on a daily wear basis for approximately 3 months.

Exclusion Criteria:

• Subjects who are older than age 40 on the date the informed consent (ICF) is signed.

• Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study.

• 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 who are using any ocular medication.

• Subjects with any grade 2 or greater finding during the slit lamp examination.

• Subjects with corneal infiltrates, of ANY GRADE, are not eligible.

• Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.

• Subjects who are allergic to any component in the study care products.

Study Design

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

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• B&L Investigational Contact Lens
Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly.
• B&L PureVision Contact Lens
Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity (VA)	Mean high contrast, distance logMAR VA for each eye between the Test and Control lenses. This measure is an average from 4 visits taking place over 3 months.	4 visits over 3 months	No
Secondary	Slit Lamp > Grade 2	Proportion of eyes with any slit lamp findings greater than grade 2 at any visit between the Test and Control lenses.	3 months	No