Clinical trial NCT01461811: Prospective Study of an Investigational Toric Soft Contact Lens
Official title: ARES Registration Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Astigmatism
Refractive Error
Keywords: toric
contact lenses
daily disposable contact lenses
astigmatism
soft contact lenses
contact lens comfort
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2011-10-28
Enrollment: 154
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 daily wear, daily disposable mode for three months.

Detailed description: Eligible participants were randomized 2:1 to wear either DAILIES® AquaComfort Plus® Toric or Focus® DAILIES® Toric.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better)
timeFrame: Up to Month 3
Secondary outcomes:
measure: Subjective Rating of Insertion Comfort
timeFrame: Up to Month 3
measure: Subjective Rating of End of Day Comfort
timeFrame: Up to Month 3
measure: Subjective Rating of Overall Comfort
timeFrame: Up to Month 3
measure: Subjective Rating of End of Day Dryness
timeFrame: Up to Month 3
measure: Subjective Rating of Overall Vision
timeFrame: Up to Month 3
measure: Subjective Rating of Overall Handling
timeFrame: Up to Month 3
measure: Lens Centration (Centered, Slight Decentration)
timeFrame: Up to Month 3
measure: Lens Fit (Optimal, Acceptably Loose, Acceptably Tight)
timeFrame: Up to Month 3
measure: Front Surface Wettability (None, Very Slight)
timeFrame: Up to Month 3
measure: Front Surface Deposits (None, Very Slight)
timeFrame: Up to Month 3
measure: Back Surface Debris/Deposits (None, Very Slight)
timeFrame: Up to Month 3
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Mary Fahmy, OD
role: STUDY_DIRECTOR
References: