Recruitment

Recruitment Status
Completed
Estimated Enrollment
192

Inclusion Criteria

Current or previous soft contact lens wearer;
Able to achieve best corrected visual acuity (BCVA) of 20/25 or better in each eye at distance (as determined by manifest refraction);
Must sign an Informed Consent document;
...
Current or previous soft contact lens wearer;
Able to achieve best corrected visual acuity (BCVA) of 20/25 or better in each eye at distance (as determined by manifest refraction);
Must sign an Informed Consent document;
Manifest cylinder less than or equal to 1.00 D;
Presbyopic and require at least 2.25 diopters (D) spectacle ADD power;
Other protocol-defined inclusion criteria may apply.
Willing and able to wear multifocal contact lenses in both eyes within the available range of powers for this trial;
Not able to achieve monocular near visual acuity (VA) 0.2 logarithm of the Minimum Angle of Resolution (logMAR) [Early Treatment of Diabetic Retinopathy Study (ETDRS)] or better in each eye with AIR OPTIX® AQUA Multifocal (AOAMF) High ADD Contact Lenses;

Exclusion Criteria

Any history of herpetic keratitis;
History of intolerance or hypersensitivity to any component of the investigational products;
Clinically significant (> 1 millimeter) anisocoria;
...
Any history of herpetic keratitis;
History of intolerance or hypersensitivity to any component of the investigational products;
Clinically significant (> 1 millimeter) anisocoria;
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;
Other protocol-defined exclusion criteria may apply.
Corneal vascularization that is mild (Grade 2) or higher;
Biomicroscopy findings (except for corneal vascularization) that are moderate (Grade 3) or severe (Grade 4);
Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator; or any use of topical ocular medications that would require instillation during contact lens wear;
A pathologically dry eye that precludes contact lens wear;
Concurrent participation in a contact lens or contact lens care product clinical trial within the previous 30 days;
Eye injury or ocular or intra-ocular surgery within 6 months prior to enrollment;
Anisometropia ≥ 1.50 D (contact lens distance prescription);
Monocular (only 1 eye with functional vision);
History of corneal or refractive surgery, irregular cornea or unilateral pseudophakia;
Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear within 6 months prior to enrollment, as determined by the investigator;

Summary

Conditions
Presbyopia
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Masking: Double (Participant, Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 50 years and 125 years
Gender
Both males and females

Inclusion Criteria

Current or previous soft contact lens wearer;
Able to achieve best corrected visual acuity (BCVA) of 20/25 or better in each eye at distance (as determined by manifest refraction);
Must sign an Informed Consent document;
...
Current or previous soft contact lens wearer;
Able to achieve best corrected visual acuity (BCVA) of 20/25 or better in each eye at distance (as determined by manifest refraction);
Must sign an Informed Consent document;
Manifest cylinder less than or equal to 1.00 D;
Presbyopic and require at least 2.25 diopters (D) spectacle ADD power;
Other protocol-defined inclusion criteria may apply.
Willing and able to wear multifocal contact lenses in both eyes within the available range of powers for this trial;
Not able to achieve monocular near visual acuity (VA) 0.2 logarithm of the Minimum Angle of Resolution (logMAR) [Early Treatment of Diabetic Retinopathy Study (ETDRS)] or better in each eye with AIR OPTIX® AQUA Multifocal (AOAMF) High ADD Contact Lenses;

Exclusion Criteria

Any history of herpetic keratitis;
History of intolerance or hypersensitivity to any component of the investigational products;
Clinically significant (> 1 millimeter) anisocoria;
...
Any history of herpetic keratitis;
History of intolerance or hypersensitivity to any component of the investigational products;
Clinically significant (> 1 millimeter) anisocoria;
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;
Other protocol-defined exclusion criteria may apply.
Corneal vascularization that is mild (Grade 2) or higher;
Biomicroscopy findings (except for corneal vascularization) that are moderate (Grade 3) or severe (Grade 4);
Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator; or any use of topical ocular medications that would require instillation during contact lens wear;
A pathologically dry eye that precludes contact lens wear;
Concurrent participation in a contact lens or contact lens care product clinical trial within the previous 30 days;
Eye injury or ocular or intra-ocular surgery within 6 months prior to enrollment;
Anisometropia ≥ 1.50 D (contact lens distance prescription);
Monocular (only 1 eye with functional vision);
History of corneal or refractive surgery, irregular cornea or unilateral pseudophakia;
Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear within 6 months prior to enrollment, as determined by the investigator;

Tracking Information

NCT #
NCT02117544
Collaborators
Not Provided
Investigators
Study Director: Sr. Clinical Manager, Vision Care, GCRA Alcon Research