Clinical Validation of the New Print on Focus DAILIES Toric
This study has been completed.
Sponsor:
CIBA VISION
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT01097863
First received: March 31, 2010
Last updated: June 26, 2012
Last verified: January 2012
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Purpose
The purpose of this study is to validate the improvements to the inversion indicator.
| Condition | Intervention |
|---|---|
|
Myopia |
Device: nelfilcon A contact lens, modified inversion indicator Device: nelfilcon A contact lens, no inversion indicator Device: nelfilcon A contact lens, inversion indicator |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- Visibility of the Inversion Indicator on Lens When Lens Was on Participant's Finger, for Example, During Lens Insertion. [ Time Frame: 1 week ] [ Designated as safety issue: No ]As assessed by the participant retrospectively after one week of wear and recorded on a questionnaire as a yes or no response to the question, "Did you notice an OK mark on the study lens while it was on your finger, for example, during lens insertion?" The positive "yes" responses are reported.
| Enrollment: | 280 |
| Study Start Date: | March 2010 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: nelfilcon A, modified inversion indicator
Nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
|
Device: nelfilcon A contact lens, modified inversion indicator
Investigational, nelfilcon A, toric, soft contact lens for daily disposable wear, with modified inversion indicator
|
|
Experimental: nelfilcon A, no inversion indicator
Nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
|
Device: nelfilcon A contact lens, no inversion indicator
Investigational, nelfilcon A, toric, soft contact lens for daily disposable wear, with no inversion indicator
|
|
Active Comparator: nelfilcon A, inversion indicator
Nelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week.
|
Device: nelfilcon A contact lens, inversion indicator
Commercially marketed, nelfilcon A, toric, soft contact lens for daily disposable wear, with inversion indicator
Other Name: Focus DAILIES Toric
|
Detailed Description:
This study was conducted in three countries under three separate protocols: P-346-C-009 sub 02 (UK), P-346-C-009 sub 03 (Germany), and P-346-C-010 (USA). The data reported represents pooled data from the three protocols.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Be of legal age and sign written Informed Consent Document. If under legal age, parent or guardian must sign Informed Consent Document and subjects ages 12 through 17 must sign Informed Assent.
- Willing and able to wear study lenses in both eyes in the available parameters.
- Light-eyed subjects.
- Able to achieve 20/40 or better distance visual acuity (VA) in each eye at time of dispensing.
- Optimal or acceptable fit in each eye at time of dispensing.
- Willing to wear the study lenses at least 8 hours a day, 5 days a week.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Eye injury or surgery within twelve weeks prior to enrollment for this trial.
- Pre-existing ocular irritation that would preclude contact lens fitting.
- Currently enrolled in an ophthalmic 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.
- RGP contact lens wearer.
- 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: | NCT01097863 History of Changes |
| Other Study ID Numbers: | P-346-C-010 |
| Study First Received: | March 31, 2010 |
| Results First Received: | May 27, 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 19, 2013