Status:
COMPLETED
Prospective Study of an Investigational Toric Soft Contact Lens
Lead Sponsor:
CIBA VISION
Conditions:
Myopia
Astigmatism
Eligibility:
All Genders
Phase:
NA
Brief Summary
The purpose of this study was to demonstrate substantial equivalence of an investigational toric soft contact lens to the commercially available Focus® DAILIES® Toric soft contact lens when worn in a ...
Detailed Description
Eligible participants were randomized 2:1 to wear either DAILIES® AquaComfort Plus® Toric or Focus® DAILIES® Toric.
Eligibility Criteria
Inclusion
- Sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and participant must sign Assent document.
- Normal eyes not using any ocular medications that would contraindicate lens wear.
- Willing and able to wear toric contact lenses in both eyes within the available range of powers for this trial.
- Spectacle cylinder prescription between 0.50 and 2.00 diopters.
- Best spectacle corrected visual acuity 20/25 (Snellen) or better in each eye at distance.
- Other protocol-defined inclusion criteria may apply.
Exclusion
- Anterior segment infection, inflammation, or abnormality.
- Any active anterior segment or systemic disease that would contraindicate contact lens wear.
- Use of systemic medications that would contraindicate lens wear.
- Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the study lenses or affect the results of this study.
- History of herpetic keratitis.
- History of refractive surgery or irregular cornea.
- History of pathologically dry eye.
- Corneal vascularization greater than 1 mm of penetration.
- Eye injury within twelve weeks immediately prior to enrollment in this trial.
- Participation in a contact lens or contact lens care product clinical trial within the previous 30 days, or concurrent participation in any clinical trial.
- Other protocol-defined exclusion criteria may apply.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT01461811
Start Date
December 1 2011
End Date
April 1 2012
Last Update
October 17 2013
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