Status:
COMPLETED
AIR OPTIX® COLORS Registration Trial
Lead Sponsor:
CIBA VISION
Conditions:
Refractive Error
Eligibility:
All Genders
Phase:
NA
Brief Summary
The purpose of this study was to evaluate the subjective and objective performance and the physiological response to AIR OPTIX® COLORS soft contact lenses compared with AIR OPTIX® AQUA contact lenses ...
Detailed Description
This study consisted of 7 scheduled visits conducted over a 3-month period. Enrolled participants were randomized (2:1) to receive either AIR OPTIX® COLORS lenses in both eyes or AIR OPTIX® AQUA lense...
Eligibility Criteria
Inclusion
- 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.
- Normal eyes and not using any ocular medications.
- Willing to wear visitint or gray-colored spherical contact lenses in both eyes within available power ranges.
- Manifest cylinder less than or equal to 0.75 diopter.
- Best spectacle corrected visual acuity greater than or equal to 20/25.
- Have current prescription glasses.
- Other protocol-defined inclusion criteria may apply.
Exclusion
- Anterior segment infection, inflammation, or abnormality.
- Any active anterior segment ocular or systemic disease that would contraindicate contact lens wear.
- Use of ocular or systemic medications for which contact lens wear could be contraindicated as determined by the investigator.
- History of refractive surgery or irregular cornea.
- History of pathologically dry eye.
- Corneal vascularization greater than 1 millimeter of penetration.
- History of herpetic keratitis.
- Eye injury within 12 weeks immediately prior to enrollment in this trial.
- Currently enrolled in any clinical trial or participation in any clinical trial within the previous 30 days.
- Other protocol-defined exclusion criteria may apply.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01440322
Start Date
September 1 2011
End Date
January 1 2012
Last Update
May 8 2014
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