NCT00768885

Brief Summary

To evaluate the wearing satisfaction of a new design of the PureVision soft contact lenses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

September 1, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 8, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

March 18, 2013

Status Verified

March 1, 2013

Enrollment Period

1 month

First QC Date

October 6, 2008

Last Update Submit

March 15, 2013

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

  • Patient satisfaction

    4 weeks

Study Arms (2)

PureVision 1

ACTIVE COMPARATOR

PureVision soft contact lens design #1.

Device: PureVision 1

PureVision 2

EXPERIMENTAL

PureVision soft contact lens design #2

Device: PureVision 2

Interventions

PureVision 1DEVICE

Currently marketed PureVision soft contact lens.

PureVision 1
PureVision 2DEVICE

Alternate design soft contact lens.

PureVision 2

Eligibility Criteria

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

You may qualify if:

  • Subject is myopic
  • Subjects who wear soft contact lenses that are exchanged at least biweekly at the time consent is obtained.

You may not qualify if:

  • Systemic disease affecting ocular health
  • Using pharmaceuticals that may affect the function of the eyes or lenses.
  • Subject possessing corneal infiltrate or corneal ulcers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kodama Eye Clinic

Kyoto, 6100121, Japan

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2008

First Posted

October 8, 2008

Study Start

September 1, 2008

Primary Completion

October 1, 2008

Study Completion

January 1, 2009

Last Updated

March 18, 2013

Record last verified: 2013-03

Locations

JP(1)