Daily Disposable Toric Comparative Trial in Europe
This study has been completed.
Sponsor:
CIBA VISION
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT01070381
First received: February 16, 2010
Last updated: June 26, 2012
Last verified: January 2012
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to investigate the subjective and objective performance of two daily disposable lenses for wearers with astigmatism.
| Condition | Intervention |
|---|---|
|
Myopia Astigmatism |
Device: nelfilcon A contact lens Device: ocufilcon D 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 Comfort [ Time Frame: 1 week of wear ] [ Designated as safety issue: No ]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.
| Enrollment: | 220 |
| Study Start Date: | January 2010 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
nelfilcon A / ocufilcon D
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.
|
Device: nelfilcon A contact lens
Commercially marketed, toric, soft contact lens for daily disposable wear
Device: ocufilcon D contact lens
Commercially marketed, toric, soft contact lens for daily disposable wear
|
|
ocufilcon D / nelfilcon A
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.
|
Device: nelfilcon A contact lens
Commercially marketed, toric, soft contact lens for daily disposable wear
Device: ocufilcon D contact lens
Commercially marketed, toric, soft contact lens for daily disposable wear
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Alcon Research ( CIBA VISION ) |
| ClinicalTrials.gov Identifier: | NCT01070381 History of Changes |
| Other Study ID Numbers: | P-346-C-008 |
| Study First Received: | February 16, 2010 |
| Results First Received: | February 25, 2011 |
| Last Updated: | June 26, 2012 |
| Health Authority: | Germany: Ethics Commission |
Additional relevant MeSH terms:
|
Astigmatism Myopia Refractive Errors Eye Diseases |
ClinicalTrials.gov processed this record on June 17, 2013