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Main
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Note: This record shows only the 20 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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00931307 |
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Date of registration:
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01/07/2009 |
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Primary sponsor: |
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Public title:
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Evaluation of Lotrafilcon A Lenses Over a Three Month Period
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Scientific title:
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Evaluation of Lotrafilcon A Lenses Over a Three Month Period |
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Date of first enrolment:
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May 2009 |
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Target sample size:
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22 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00931307 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- On examination, have ocular findings considered to be "normal" and which would not
prevent a subject from safely wearing contact lenses.
- Be willing and able to follow instructions and meet the schedule of follow-up visits
as defined in the informed consent.
- Be able to wear the study lenses in the available powers.
- Currently wear contact lenses for a minimum of 5 days a week, and at least 8 hours a
day.
- Other protocol inclusion/exclusion 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 an ophthalmic clinical trial.
- Evidence of systemic or ocular abnormality, infection or disease likely to affect
successful wear of contact lenses or use of their accessory solutions.
- Any use of medications for which contact lens wear would be contraindicated, in the
opinion of the investigator.
- History of corneal refractive surgery.
- Other protocol inclusion/exclusion criteria may apply.
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Myopia
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Intervention(s)
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Device: Lotrafilcon A contact lens
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Primary Outcome(s)
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Comfort After Insertion
[Time Frame: 3 months]
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Secondary ID(s)
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P-335-C-013
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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