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

NCT01449526 | Completed Results

• 1 other identifier: 661
• Study Type: interventional
• Target: 166
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Myopia

Keywords

contact lens

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Slit Lamp > Grade 2

  3 months

Study Arms (2)

B&L Investigational Contact Lens

EXPERIMENTAL

The Bausch + Lomb investigational silicone hydrogel contact lens

Device: B&L Investigational Contact Lens

B&L PureVision Contact Lens

ACTIVE COMPARATOR

The Bausch + Lomb PureVision silicone hydrogel contact lens

Device: B&L PureVision Contact Lens

Interventions

B&L Investigational Contact Lens DEVICE

Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly.

B&L Investigational Contact Lens

B&L PureVision Contact Lens DEVICE

Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly.

B&L PureVision Contact Lens

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Robert Steffen, OD, MS
• Organization: Bausch & Lomb Incorporated

robert.steffen@bausch.com

585-338-6399

Study Officials

• Robert Steffen, OD, MS

  Bausch & Lomb Incorporated

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2011
• First Posted: October 10, 2011
• Study Start: August 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2012
• Last Updated: February 18, 2015
• Results First Posted: February 18, 2015

Record last verified: 2015-02