Evaluation of Two Daily Disposable Contact Lenses for Wearers With Astigmatism

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alcon Research ( CIBA VISION )

ClinicalTrials.gov Identifier:

NCT01207466

First received: September 21, 2010

Last updated: June 27, 2012

Last verified: January 2012

Purpose

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

Condition	Intervention
Astigmatism Myopia	Device: Nelfilcon A investigational contact lens Device: Nelfilcon A commercial contact lens

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Quality of Vision (Crisp and Clear) [ Time Frame: 1 week of wear ] [ Designated as safety issue: No ]
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.

Enrollment:	95
Study Start Date:	September 2010
Study Completion Date:	October 2010
Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Nelfilcon A invest'l / nelfilconA comm'l 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 lens Investigational, soft contact lens for astigmatism worn on a daily disposable basis. Device: Nelfilcon A commercial contact lens Commercially marketed, soft contact lens for astigmatism worn on a daily disposable basis. Other Name: Focus DAILIES Toric
Nelfilcon A comm'l / nelfilconA invest'l 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 lens Investigational, soft contact lens for astigmatism worn on a daily disposable basis. Device: Nelfilcon A commercial contact lens Commercially marketed, soft contact lens for astigmatism worn on a daily disposable basis. Other Name: Focus DAILIES Toric

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Exclusion Criteria:

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
Other protocol exclusion criteria may apply

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:	NCT01207466 History of Changes
Other Study ID Numbers:	P-415-C-001 sub 2
Study First Received:	September 21, 2010
Results First Received:	July 28, 2011
Last Updated:	June 27, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Astigmatism
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 16, 2013