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

Primary Purpose

Myopia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

PureVision2 HD contact lenses

Spectacles

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

15 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Bausch & Lomb, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Spectacles

PureVision2 HD contact lenses

Arm Description

The subject's habitual spectacles (updated or confirmed as correct within the last 2 years)

Currently marketed Bausch + Lomb PureVision2 HD contact lenses

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01416142

First Posted

August 11, 2011

Last Updated

November 7, 2013

Sponsor

Bausch & Lomb Incorporated

1. Study Identification

Unique Protocol Identification Number

NCT01416142

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Completed

Study Start Date

July 2011 (undefined)

Primary Completion Date

August 2011 (Actual)

Study Completion Date

September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myopia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

63 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Spectacles

Arm Type

Active Comparator

Arm Description

The subject's habitual spectacles (updated or confirmed as correct within the last 2 years)

Arm Title

PureVision2 HD contact lenses

Arm Type

Experimental

Arm Description

Currently marketed Bausch + Lomb PureVision2 HD contact lenses

Intervention Type

Device

Intervention Name(s)

PureVision2 HD contact lenses

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Spectacles

Intervention Description

Spectacles to be worn throughout 1/2 of an HD movie.

Primary Outcome Measure Information:

Title

Visual Acuity

Description

Time Frame

Screening visit (Visit 1) and one week follow-up(Visit 3)

Secondary Outcome Measure Information:

Title

Preference for Test Lens

Description

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.

Time Frame

During the movie (Visit 2)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bev Barna, CCRA

Organizational Affiliation

Bausch & Lomb Incorporated

Official's Role

Study Director

Facility Information:

Facility Name

Bausch & Lomb, Inc.

City

Rochester

State/Province

New York

ZIP/Postal Code

14609

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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