NCT01207466

Brief Summary

The purpose of this trial is to compare the performance of two contact lenses for contact lens wearers with astigmatism.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2010

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

September 1, 2010

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2010

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
11 months until next milestone

Results Posted

Study results publicly available

August 26, 2011

Completed
Last Updated

July 10, 2012

Status Verified

January 1, 2012

Enrollment Period

1 month

First QC Date

September 21, 2010

Results QC Date

July 28, 2011

Last Update Submit

June 27, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • Quality of Vision (Crisp and Clear)

    Quality of vision (crisp and clear), as interpreted and reported by the participant by eye on a questionnaire as a single, retrospective evaluation of one week's wear time. Quality of vision was assessed on a 10-point scale, with 1 being poor and 10 being excellent.

    1 week of wear

Study Arms (2)

Nelfilcon A invest'l / nelfilconA comm'l

OTHER

Nelfilcon A investigational toric contact lenses worn first, with nelfilcon A commercial toric contact lenses worn second. Each product worn bilaterally on a daily disposable basis for one week.

Device: Nelfilcon A investigational contact lensDevice: Nelfilcon A commercial contact lens

Nelfilcon A comm'l / nelfilconA invest'l

OTHER

Nelfilcon A commercial toric contact lenses worn first, with nelfilcon A investigational toric contact lenses worn second. Each product worn bilaterally on a daily disposable basis for one week.

Device: Nelfilcon A investigational contact lensDevice: Nelfilcon A commercial contact lens

Interventions

Investigational, soft contact lens for astigmatism worn on a daily disposable basis.

Nelfilcon A comm'l / nelfilconA invest'lNelfilcon A invest'l / nelfilconA comm'l

Commercially marketed, soft contact lens for astigmatism worn on a daily disposable basis.

Also known as: Focus DAILIES Toric
Nelfilcon A comm'l / nelfilconA invest'lNelfilcon A invest'l / nelfilconA comm'l

Eligibility Criteria

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

You may qualify if:

  • Currently wearing soft contact lenses with astigmatism correction

You may not qualify if:

  • Eye injury or surgery within twelve weeks prior to enrollment
  • Currently enrolled in an ophthalmic clinical trial
  • Strabismus
  • Any use of medications for which contact lens wear could be contraindicated as determined by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

AstigmatismMyopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

Title
Joe Rappon, OD, MS, FAAO / Head, Clinical Trial Management
Organization
CIBA VISION

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

September 21, 2010

First Posted

September 23, 2010

Study Start

September 1, 2010

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

July 10, 2012

Results First Posted

August 26, 2011

Record last verified: 2012-01