NCT00661687

Brief Summary

The objective of this study is to evaluate the performance of the PureVision Lens designs when worn on a 30-day continuous wear basis

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
206

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2007

Shorter than P25 for phase_3

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 18, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

October 15, 2010

Completed
Last Updated

December 12, 2011

Status Verified

December 1, 2011

Enrollment Period

2 months

First QC Date

April 16, 2008

Results QC Date

February 20, 2009

Last Update Submit

December 7, 2011

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

  • Subjective Responses to Symptoms/Complaints

    Subjective responses to symptoms/complaints on a scale 0-100, where 100 is the most favorable score. Subjects rated various aspects of lens comfort, vision, and handling. The average of each symptom/complaint over all follow-up visits was assessed as the primary endpoint.

    Measured at screening/dispensing visit, 1 day, 1 week and 1 month follow-up visits

Secondary Outcomes (2)

  • LogMAR Visual Acuity

    Mean over all visits - 1 day, 1 week, 1 month

  • Lens Characteristics

    Over all scheduled visits day 1 - 1 month

Study Arms (2)

Purevision Contact Lens #1

ACTIVE COMPARATOR

PureVision Soft Contact Lens Design (currently marketed)

Device: Currently Marketed PureVision Contact Lens.

PureVision Contact Lens #2

EXPERIMENTAL

Redesign of the currently marketed PureVision soft contact lens.

Device: Alternate Design of the PureVision Contact Lens.

Interventions

Currently Marketed PureVision Contact Lens.DEVICE

Contact lens for continuous wear

Purevision Contact Lens #1
Alternate Design of the PureVision Contact Lens.DEVICE

Contact lens for continuous wear

PureVision Contact Lens #2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • subject is myopic
  • VA correctable to 0.3 logMAR or better (driving vision)
  • Clear central cornea

You may not qualify if:

  • Systemic disease affecting ocular health
  • using systemic or topical medications
  • wear monovision, multifocal or toric contact lenses
  • Any grade 2 or greater slit lamp findings

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Laser Focus Sdn Bhd, Vision Correction Centre

Johor Bahru, Johor Bahru, 80400, Malaysia

Location

Asian Eye Institute

Makati City, 1200, Philippines

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Limitations and Caveats

2 participants discontinued due to adverse events, not classified as serious. One subject in the test group developed corneal ulcer, one subject in the control group developed a central epithelial defect, both conditions resolved following treatment.

Results Point of Contact

Title
Gerard Cairns
Organization
Bausch & Lomb Incorporated
gerard.cairns@bausch.com
(585)338 - 5170

Study Officials

  • Gerard Cairns, MCOptom, PhD

    Bausch & Lomb Incorporated

    STUDY DIRECTOR

  • Benny Chian, MCOptom

    Laser Focus Sdn Bhd, Vision Correction Centre

    PRINCIPAL INVESTIGATOR

  • Harvey Siy Uy, MD

    Asian Eye Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2008

First Posted

April 18, 2008

Study Start

December 1, 2007

Primary Completion

February 1, 2008

Study Completion

June 1, 2008

Last Updated

December 12, 2011

Results First Posted

October 15, 2010

Record last verified: 2011-12

Locations

MY(1)PH(1)