Daily Disposable Toric Comparative Trial in Europe

Not Applicable

Completed

• Conditions: Myopia; Astigmatism
• Interventions: Device: nelfilcon A contact lens; Device: ocufilcon D contact lens

• Registration Number: NCT01070381
• Lead Sponsor: CIBA VISION

Brief Summary

The purpose of this study is to investigate the subjective and objective performance of two daily disposable lenses for wearers with astigmatism.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-02-16
• Study First Submitted QC: 2010-02-17
• Study First Posted: 2010-02-18
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Results First Submitted: 2011-02-25
• Results First Submitted QC: 2011-02-25
• Results First Posted: 2011-03-24
• Status Verified: 2012-01
• Last Update Submitted: 2013-11-19
• Last Update Posted: 2013-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• Current soft contact lens wearers able to be fit with soft toric lenses in the protocol-specified parameters.
• Achieve 0.5 or better distance visual acuity in each eye at time of dispense.
• Achieve acceptable or optimal fit in each eye at time of dispense.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

• Habitual daily disposable contact lens wearer.
• Sleeps in contact lenses overnight.
• Currently enrolled in an ophthalmic clinical trial.
• Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ocufilcon D / nelfilcon A	ocufilcon D contact lens	Ocufilcon D contact lenses worn first, with nelfilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
nelfilcon A / ocufilcon D	ocufilcon D contact lens	Nelfilcon A contact lenses worn first, with ocufilcon D contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
nelfilcon A / ocufilcon D	nelfilcon A contact lens	Nelfilcon A contact lenses worn first, with ocufilcon D contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
ocufilcon D / nelfilcon A	nelfilcon A contact lens	Ocufilcon D contact lenses worn first, with nelfilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.

Primary Outcome Measures

Name	Time	Method
Overall Comfort	1 week of wear	Overall Comfort, as interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 1-week's wear time. Overall comfort is measured on a 10-point scale, with 1 being poor and 10 being excellent.