Clinical Comparison of Two Daily Disposable Contact Lenses in a Population of Daily Disposable Contact Lens Wearers
This study has been completed.
Sponsor:
CIBA VISION
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT01233076
First received: November 1, 2010
Last updated: June 26, 2012
Last verified: January 2012
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Purpose
The purpose of this study is to evaluate the performance of two commercially marketed daily disposable contact lenses in a population of daily disposable contact lens wearers.
| Condition | Intervention |
|---|---|
|
Myopia |
Device: Nelfilcon A contact lens Device: Narafilcon B contact lens |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- Overall Vision Quality [ Time Frame: 1 week of wear ] [ Designated as safety issue: No ]Overall vision quality, as interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear. Overall vision quality is evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.
| Enrollment: | 60 |
| Study Start Date: | October 2010 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Nelfilcon A / Narafilcon B
Nelfilcon A worn first, with narafilcon B worn second. Each product worn bilaterally in a daily wear, daily disposable basis for one week.
|
Device: Nelfilcon A contact lens
Commercially marketed, spherical contact lens for daily wear, daily disposable use
Other Name: DAILIES AquaComfort Plus
Device: Narafilcon B contact lens
Commercially marketed (US), spherical contact lens for daily wear, daily disposable use
Other Name: 1-DAY ACUVUE TruEye
|
|
Narafilcon B / Nelfilcon A
Narafilcon B worn first, with nelfilcon A worn second. Each product worn bilaterally in a daily wear, daily disposable basis for one week.
|
Device: Nelfilcon A contact lens
Commercially marketed, spherical contact lens for daily wear, daily disposable use
Other Name: DAILIES AquaComfort Plus
Device: Narafilcon B contact lens
Commercially marketed (US), spherical contact lens for daily wear, daily disposable use
Other Name: 1-DAY ACUVUE TruEye
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Currently wearing daily disposable lenses in daily wear, daily disposable modality, except DAILIES AquaComfort Plus and 1-DAY ACUVUE TruEye.
- Able to wear study lenses in the available powers from -1.00D to -6.00D.
- Other protocol-defined inclusion/exclusion criteria may apply.
Exclusion Criteria:
- Eye injury within twelve weeks of enrollment.
- History of corneal or refractive surgery.
- Pre-existing ocular irritation that would preclude contact lens fitting.
- Currently enrolled in any clinical trial.
- Currently wearing DAILIES AquaComfort Plus or 1-DAY ACUVUE TruEye lenses.
- Monovision correction during the study.
- Other protocol-defined inclusion/exclusion criteria may apply.
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Alcon Research ( CIBA VISION ) |
| ClinicalTrials.gov Identifier: | NCT01233076 History of Changes |
| Other Study ID Numbers: | P-337-C-034 |
| Study First Received: | November 1, 2010 |
| Results First Received: | August 5, 2011 |
| Last Updated: | June 26, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Myopia Refractive Errors Eye Diseases |
ClinicalTrials.gov processed this record on May 23, 2013