Clinical Comparison of Two Daily Disposable Toric Lenses

Not Applicable

Completed

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

• Registration Number: NCT01362894
• Lead Sponsor: CIBA VISION

Brief Summary

The purpose of this trial was to compare the performance of two contact lenses commercially available for people with astigmatism.

Detailed Description

This trial compared the performance of two commercialized daily disposable contact lenses in Germany.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-27
• Study First Submitted QC: 2011-05-27
• Study First Posted: 2011-06-01
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2012-07
• Results First Submitted: 2012-07-03
• Results First Submitted QC: 2012-07-03
• Last Update Submitted: 2012-07-03
• Results First Posted: 2012-08-09
• Last Update Posted: 2012-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• Sign written informed consent.
• Germany: Be of legal age.
• Current monthly or weekly toric soft lens wearer able to be fit in both eyes with soft toric lenses in the study parameters.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

• Eye injury or surgery within twelve weeks.
• Pre-existing ocular irritation that would preclude contact lens fitting.
• Currently enrolled in an ophthalmic clinical trial.
• Wears contact lenses overnight while sleeping.
• Habitual daily disposable contact lens wearer.
• Monovision correction during the study.
• Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
nelfilcon A / etafilcon A	etafilcon A contact lens	Nelfilcon A lenses worn first, with etafilcon A lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
etafilcon A / nelfilcon A	nelfilcon A contact lens	Etafilcon A lenses worn first, with nelfilcon A lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
etafilcon A / nelfilcon A	etafilcon A contact lens	Etafilcon A lenses worn first, with nelfilcon A lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
nelfilcon A / etafilcon A	nelfilcon A contact lens	Nelfilcon A lenses worn first, with etafilcon A 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 Vision	1 week, replacing lenses daily	As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent.
Overall Comfort	1 week, replacing lenses daily	As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall comfort was rated on a 10-point scale, with 1 being poor and 10 being excellent.
Overall Handling	1 week, replacing lenses daily	As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall handling was rated on a 10-point scale, with 1 being difficult and 10 being easy.
Overall Satisfaction	1 week, replacing lenses daily	As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent.

Secondary Outcome Measures

Name	Time	Method
Ease of Selecting Final Lens Power	Day 0	As interpreted by the investigator at time of lens fitting and recorded on a questionnaire. Ease of selecting final lens power was rated on a 10-point scale, with 1 being difficult and 10 being easy.