Back to resultsClinical Comparison of Two Daily Disposable Lenses Among Daily Disposable Lens Wearers
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
nelfilcon A
filcon II 3
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
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.
Sites / Locations
- W.Hartwig - Qualität in jeder Hinsicht
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
nelfilcon A / filcon II 3
filcon II 3 / nelfilcon A
Arm Description
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 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.
Outcomes
Primary Outcome Measures
subjective ratings and preferences
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01134211
Brief Title
Clinical Comparison of Two Daily Disposable Lenses Among Daily Disposable Lens Wearers
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CIBA VISION
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
316 (Actual)
8. Arms, Groups, and Interventions
Arm Title
nelfilcon A / filcon II 3
Arm Type
Other
Arm Description
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.
Arm Title
filcon II 3 / nelfilcon A
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
nelfilcon A
Intervention Description
Commercially marketed, single-vision, soft contact lens for daily disposable wear
Intervention Type
Device
Intervention Name(s)
filcon II 3
Intervention Description
Commercially marketed, single-vision, soft contact lens for daily disposable wear
Primary Outcome Measure Information:
Title
subjective ratings and preferences
Time Frame
2 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
W.Hartwig - Qualität in jeder Hinsicht
City
Heikendorf
ZIP/Postal Code
24226
Country
Germany
12. IPD Sharing Statement
Citations:
Citation
OVS, Marx et al. Subjective Performance of hydrogel and silicone hydrogel daily disposable contact lenses). AAO poster presentation 2014.
Results Reference
result
Learn more about this trial
Clinical Comparison of Two Daily Disposable Lenses Among Daily Disposable Lens Wearers
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