|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 October 2017 |
|
Main ID: |
NCT01097863 |
|
Date of registration:
|
31/03/2010 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Clinical Validation of the New Print on Focus DAILIES Toric
|
|
Scientific title:
|
|
|
Date of first enrolment:
|
March 2010 |
|
Target sample size:
|
280 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT01097863 |
|
Study type:
|
Interventional |
|
Study design:
|
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Key inclusion & exclusion 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.
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Myopia
|
|
Intervention(s)
|
|
Device: nelfilcon A contact lens, no inversion indicator
|
|
Device: nelfilcon A contact lens, inversion indicator
|
|
Device: nelfilcon A contact lens, modified inversion indicator
|
|
Primary Outcome(s)
|
|
Visibility of the Inversion Indicator on Lens When Lens Was on Participant's Finger, for Example, During Lens Insertion.
[Time Frame: 1 week]
|
|
Secondary ID(s)
|
|
P-346-C-010
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|