A Study to Evaluate the Product Performance of a Daily Disposable Contact Lens

NCT01192126 | Completed Results

• 1 other identifier: 662
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to evaluate the product performance of visual acuity of the Bausch + Lomb investigational daily disposable contact lenses compared to the currently marketed Johnson \& Johnson Acuvue Moist contact lenses.

Conditions

Myopia; Contact Lenses

Outcome Measures

Primary Outcomes (2)

• Visual Acuity

  Distance High contrast logMAR visual acuity (VA), difference between the test and control lens at dispensing visit and 1 week follow-up, crossover visit and 1 week follow-up.

  Dispensing Visit and 1 week follow-up

• Slit Lamp Examination > Grade 2

  Slit lamp findings for each eye will be assessed at each study visit, including epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates, will be graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). Slit lamp \> 2.

  All study visits from screening through 2 week follow-up

Study Arms (2)

Bausch & Lomb new daily disposable

EXPERIMENTAL

New daily disposable contact lenses

Device: Bausch & Lomb new daily disposable

Johnson & Johnson Acuvue Moist

ACTIVE COMPARATOR

Contact lenses

Device: Johnson & Johnson Acuvue Moist

Interventions

Bausch & Lomb new daily disposable DEVICE

Test lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis.

Bausch & Lomb new daily disposable

Johnson & Johnson Acuvue Moist DEVICE

Control lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis.

Johnson & Johnson Acuvue Moist

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be adapted soft contact lens wearers that are interested in daily disposable wear or currently adapted daily disposable soft contact lens wearers.
• Subjects must agree to wear study lenses on a daily disposable basis for approximately one week and crossover to wear another study lens for one week.
• Subjects must be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
• Subjects must have clear central corneas that are free of any anterior segment disorders.
• Subjects must be myopic and require lens correction from -1.00 D to -6.00 diopters (D) in each eye.

You may not qualify if:

• Subjects who have worn gas permeable contact lenses within the last 30 days or who have worn polymethylmethacrylate lenses within the last 3 months.
• Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an affect 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 who are not correctable to 32 letters (0.3 logMAR) in each eye with soft spherical contact lenses.
• Subjects who currently wear monovision, multifocal, or toric contact lenses.
• Subjects with an ocular astigmatism of 1.00 D or greater in either eye.
• Subjects with anisometropia (spherical equivalent) of greater than 1.00 D.
• Subjects with any grade 2 or greater finding during the slit lamp examination (refer to Appendix B for methods of clinical evaluation).
• Subjects with corneal infiltrates, of ANY GRADE, are not eligible.
• Subjects with any "Present" finding during the slit lamp examination (refer to Appendix B for methods of clinical evaluation) that, in the Investigator's judgment, interferes with contact lens wear.
• Subjects with any scar or neovascularization within the central 4 mm of the cornea. Subjects with minor peripheral corneal scarring (that does not extend into the central area), that in the Investigator's judgment, does not interfere with contact lens wear, are eligible for this study.
• Subjects who are aphakic.
• Subjects who are amblyopic.
• Subjects who have presbyopia.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Bausch & Lomb

Rochester, New York, 14609, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Dr. Robert Steffen OD
• Organization: Bausch & Lomb Incorporated

robert.steffen@bausch.com

585-338-6399

Study Officials

• Bev Barna

  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: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2010
• First Posted: August 31, 2010
• Study Start: August 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: January 3, 2014
• Results First Posted: January 3, 2014

Record last verified: 2013-11

Locations

US (1)