Clinical Comparison of Two Daily Disposable Lenses Among Daily Disposable Lens Wearers

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: nelfilcon A; Device: filcon II 3

• Registration Number: NCT01134211
• Lead Sponsor: CIBA VISION

Brief Summary

The primary objective of this trial is to evaluate the subjective performance of two different daily disposable contact lenses in a population of daily disposable lens wearers.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-27
• Study First Submitted QC: 2010-05-27
• Study First Posted: 2010-05-31
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2011-10
• Last Update Submitted: 2016-11-17
• Last Update Posted: 2016-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 316

Inclusion Criteria

• Currently wearing any spherical daily disposable lens in daily wear, daily disposable modality for at least 3 months prior to enrollment with the exception of the 2 study products
• Currently Wearing lenses at least 8 hrs/day and 5 days/week.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

• Eye injury or surgery within twelve weeks immediately prior to enrollment for this trial.
• Pre-existing ocular irritation that would preclude contact lens fitting.
• Currently enrolled in any clinical trial.
• Evidence of systemic or ocular abnormality, infection, or disease which is likely to affect successful wear of contact lenses or use of their accessory solutions as determined by the investigator.
• Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
• Prior history of corneal or refractive surgery.
• Requires monovision correction.
• Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
nelfilcon A / filcon II 3	nelfilcon A	Nelfilcon A contact lenses worn first, with filcon II 3 contact lenses worn second. Both products worn in both eyes on a daily wear, daily disposable basis for one week each.
filcon II 3 / nelfilcon A	nelfilcon A	Filcon II 3 contact lenses worn first, with nelfilcon A contact lenses worn second. Both products worn in both eyes on a daily wear, daily disposable basis for one week each.
nelfilcon A / filcon II 3	filcon II 3	Nelfilcon A contact lenses worn first, with filcon II 3 contact lenses worn second. Both products worn in both eyes on a daily wear, daily disposable basis for one week each.
filcon II 3 / nelfilcon A	filcon II 3	Filcon II 3 contact lenses worn first, with nelfilcon A contact lenses worn second. Both products worn in both eyes on a daily wear, daily disposable basis for one week each.

Primary Outcome Measures

Name	Time	Method
subjective ratings and preferences	2 weeks

Trial Locations

Locations (1)

W.Hartwig - Qualität in jeder Hinsicht; 🇩🇪 Heikendorf, Germany