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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01192126
• Other study ID #: 662
• Status: Completed
• Phase: N/A
• First received: August 30, 2010
• Last updated: November 14, 2013
• Start date: August 2010
• Est. completion date: October 2010

Study information

• Verified date: November 2013
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

• Subjects who have had any corneal surgery (eg, refractive surgery).

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Contact Lenses
• Myopia

Intervention

Device:
• Bausch & Lomb new daily disposable
Test lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis.
• Johnson & Johnson Acuvue Moist
Control lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis.

Locations

Country	Name	City	State
United States	Bausch & Lomb	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No