A Study to Evaluate the Product Performance of the PureVision®2 High Definition (HD) Contact Lens

Myopia Clinical Trial

Official title:

A Study to Evaluate the Product Performance of the PureVision®2 HD Contact Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01416142
• Other study ID #: 701E
• Status: Completed
• Phase: N/A
• First received: August 11, 2011
• Last updated: November 7, 2013
• Start date: July 2011
• Est. completion date: September 2011

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 this study is to evaluate the product performance of PureVision2 HD contact lenses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: September 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 30 Years

Eligibility

Inclusion Criteria:

• Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings

• Subjects must be myopic or hyperopic and require lens correction in each eye

• Subjects must own a pair of spectacles and the spectacle prescription must have been updated or confirmed as correct within the last 2 years.

Exclusion Criteria:

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

• Any systemic disease affecting ocular health.

• Using any systemic or topical medications that will affect ocular physiology or lens performance.

• Allergic to any component in the Biotrue multi-purpose solution

Study Design

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

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• PureVision2 HD contact lenses
Lenses to be worn through 1/2 of an HD movie. Following the movie, all subjects were to wear the dispensed contact lenses on a daily wear basis for approximately one week.
• Spectacles
Spectacles to be worn throughout 1/2 of an HD movie.

Locations

Country	Name	City	State
United States	Bausch & Lomb, Inc.	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	Visual acuity(VA) measured at the screening visit (all eligible participants) while wearing spectacles and the VA measured at the end of study (Visit 3) 1-Week wearing PureVision2 HD lenses. VA wearing spectacles vs. VA wearing PureVision2 HD Lenses, lower the number the better the VA.	Screening visit (Visit 1) and one week follow-up(Visit 3)	No
Secondary	Preference for Test Lens	Proportion of participants preferring the Test lens over their spectacles. Participants changed from Spectacles to PureVision Lenses or PureVision Lenses to spectacles during movie intermission.	During the movie (Visit 2)	No