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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: |
NCT01362907 |
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Date of registration:
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27/05/2011 |
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Primary sponsor: |
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Public title:
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Clinical Comparison of Silicone Hydrogel and HEMA-based Daily Disposable Contact Lenses
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Scientific title:
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Date of first enrolment:
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May 2011 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01362907 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Normal eyes with no use of ocular medications.
- Be of legal age of consent and sign Informed Consent document. If under legal age of
consent, legally authorized representative must sign Informed Consent document and
subject must sign Assent document.
- Willing and able to wear spherical contact lenses for protocol-specified timeframe
within the available range of powers (-1.00 D to -6.00D in 0.25D steps).
- Visual acuity with study lenses 20/25 or better.
- Cylinder less than or equal to 0.75 D.
- Currently wearing daily disposable lenses.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Anterior segment infection, inflammation, or abnormality.
- Any active anterior segment ocular disease that would contraindicate contact lens
wear.
- Any use of systemic medications for which contact lens wear could be contraindicated
as determined by the investigator.
- History of refractive surgery or irregular cornea.
- Eye injury within twelve weeks immediately prior to enrollment for this trial.
- Currently enrolled in any clinical trial.
- Other protocol-defined 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: Delefilcon A contact lens
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Device: Etafilcon A contact lens
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Primary Outcome(s)
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Corrected Distance Monocular Visual Measurement Reported as Visual Acuity (VA)
[Time Frame: 1 week of wear, replacing lenses daily]
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Overall Comfort
[Time Frame: 1 week of wear, replacing lenses daily]
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Overall Handling
[Time Frame: 1 week of wear, replacing lenses daily]
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Overall Vision Quality
[Time Frame: 1 week of wear, replacing lenses daily]
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Secondary Outcome(s)
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Overall Lens Fit
[Time Frame: 1 week of wear, replacing lenses daily]
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Secondary ID(s)
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P-347-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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