Evaluation of Two Daily Disposable Contact Lenses for Wearers With Astigmatism

Not Applicable

Completed

• Conditions: Astigmatism; Myopia
• Interventions: Device: Nelfilcon A investigational contact lens; Device: Nelfilcon A commercial contact lens

• Registration Number: NCT01207466
• Lead Sponsor: CIBA VISION

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-21
• Study First Submitted QC: 2010-09-21
• Study First Posted: 2010-09-23
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Results First Submitted: 2011-07-28
• Results First Submitted QC: 2011-07-28
• Results First Posted: 2011-08-26
• Status Verified: 2012-01
• Last Update Submitted: 2012-06-27
• Last Update Posted: 2012-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nelfilcon A invest'l / nelfilconA comm'l	Nelfilcon A investigational contact lens	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.
Nelfilcon A invest'l / nelfilconA comm'l	Nelfilcon A commercial contact lens	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.
Nelfilcon A comm'l / nelfilconA invest'l	Nelfilcon A investigational contact lens	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.
Nelfilcon A comm'l / nelfilconA invest'l	Nelfilcon A commercial contact lens	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.

Primary Outcome Measures

Name	Time	Method
Quality of Vision (Crisp and Clear)	1 week of wear	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.