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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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22 April 2013 |
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Main ID: |
NCT01473160 |
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Date of registration:
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14/11/2011 |
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Primary sponsor: |
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Public title:
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Daily Disposable Contact Lens Tear Film Study
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Scientific title:
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DAILIES TOTAL1 Pre-Lens Tear Film Performance - Pilot Trial |
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Date of first enrolment:
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November 2011 |
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Target sample size:
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9 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01473160 |
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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: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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Countries of recruitment
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United Kingdom
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Be of legal age of consent and sign Informed Consent document.
- Willing and able to wear spherical contact lenses for 16 hours.
- Willing and able to wear spherical contact lenses within the available range of
powers.
- Best corrected spectacle visual acuity equal or better than 20/25 or 6/7.5.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Anterior segment infection, inflammation, or abnormality.
- Any use of systemic medications for which contact lens wear could be contraindicated.
- History of refractive surgery or irregular cornea.
- Currently enrolled in any clinical trial.
- Eye injury within twelve weeks prior to enrollment.
- Other protocol-defined exclusion criteria may apply.
Age minimum:
18 Years
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: narafilcon A contact lens
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Primary Outcome(s)
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Average Ocular Surface Temperature
[Time Frame: Up to 16 hours after lens insertion]
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Average Tear Meniscus Height
[Time Frame: Up to 16 hours after lens insertion]
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Number of Participants With Corrected Visual Acuity of 0.0 or Better
[Time Frame: Up to 16 hours after lens insertion]
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Pre-Lens Noninvasive Tear Break-Up Time
[Time Frame: Up to 16 hours after lens insertion]
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Secondary Outcome(s)
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Number of Participants With Adequate Lens Fit
[Time Frame: Up to 16 hours after lens insertion]
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Subjective Comfort
[Time Frame: Up to 16 hours after lens insertion]
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Subjective Vision
[Time Frame: Up to 16 hours after lens insertion]
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Secondary ID(s)
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P-347-C-014v2
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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