Evaluation of Two Daily Disposable Contact Lenses for Wearers With Astigmatism

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

Study Overview

• Status: Completed
• Conditions: Astigmatism; Myopia
• Intervention / Treatment: Device: Nelfilcon A investigational contact lens; Device: Nelfilcon A commercial contact lens

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Currently wearing soft contact lenses with astigmatism correction
• Other protocol inclusion criteria may apply

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 Names: Focus DAILIES Toric
Other: 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 Names: Focus DAILIES Toric

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: CIBA VISION

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: September 21, 2010
• First Submitted That Met QC Criteria: September 21, 2010
• First Posted (Estimate): September 23, 2010

Study Record Updates

• Last Update Posted (Estimate): July 10, 2012
• Last Update Submitted That Met QC Criteria: June 27, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: P-415-C-001 sub 2