NCT00958828

Brief Summary

The purpose of this study is to evaluate the performance of two daily disposable contact lenses in a population of daily disposable contact lens wearers.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
178

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2009

Shorter than P25 for not_applicable

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

July 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 11, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 13, 2009

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

October 19, 2010

Completed
Last Updated

July 10, 2012

Status Verified

January 1, 2012

Enrollment Period

2 months

First QC Date

August 11, 2009

Results QC Date

September 23, 2010

Last Update Submit

June 26, 2012

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

  • Overall Lens Satisfaction

    Overall Lens Satisfaction, as interpreted by the subject and reported by the subject on a questionnaire as a single, retrospective evaluation of 1-week's wear time. Overall lens satisfaction was measured on a 10-point scale, with 1 being poor and 10 being excellent.

    After 1 week of wear

Study Arms (2)

Nelfilcon A / Narafilcon A

OTHER

Nelfilcon A contact lenses, then Narafilcon A contact lenses

Device: Nelfilcon A contact lensDevice: Narafilcon A contact lens

Narafilcon A / Nelfilcon A

OTHER

Narafilcon A contact lenses, then Nelfilcon A contact lenses

Device: Nelfilcon A contact lensDevice: Narafilcon A contact lens

Interventions

Nelfilcon A contact lensDEVICE

Spherical, soft contact lens for daily disposable wear

Narafilcon A / Nelfilcon ANelfilcon A / Narafilcon A
Narafilcon A contact lensDEVICE

Spherical, soft contact lens for daily disposable wear

Narafilcon A / Nelfilcon ANelfilcon A / Narafilcon A

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Currently wearing any spherical daily disposable contact lens except the two study products for at least 3 months prior to enrollment.
  • Currently wearing contact lenses at least 8 hours/day and 5 days/week.

You may not qualify if:

  • Eye injury or surgery within twelve weeks immediately prior to enrollment.
  • Currently enrolled in any clinical trial.
  • Prior history of corneal or refractive surgery.
  • Monovision correction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

Title
Priya Janakiraman, OD, FAAO / Head, Global Clinical Affairs
Organization
CIBA VISION
priya.janakiraman@cibavision.com
1-800-241-7629

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2009

First Posted

August 13, 2009

Study Start

July 1, 2009

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

July 10, 2012

Results First Posted

October 19, 2010

Record last verified: 2012-01