Multifocal High ADD Contact Lens Proof of Concept Trial
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 192
Inclusion Criteria
- Current or previous soft contact lens wearer;
- Other protocol-defined inclusion criteria may apply.
- Manifest cylinder less than or equal to 1.00 D;
- ...
- Current or previous soft contact lens wearer;
- Other protocol-defined inclusion criteria may apply.
- Manifest cylinder less than or equal to 1.00 D;
- Able to achieve best corrected visual acuity (BCVA) of 20/25 or better in each eye at distance (as determined by manifest refraction);
- Willing and able to wear multifocal contact lenses in both eyes within the available range of powers for this trial;
- Must sign an Informed Consent document;
- Presbyopic and require at least 2.25 diopters (D) spectacle ADD power;
- 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
- Clinically significant (> 1 millimeter) anisocoria;
- Anisometropia ≥ 1.50 D (contact lens distance prescription);
- Other protocol-defined exclusion criteria may apply.
- ...
- Clinically significant (> 1 millimeter) anisocoria;
- Anisometropia ≥ 1.50 D (contact lens distance prescription);
- Other protocol-defined exclusion criteria may apply.
- Any history of herpetic keratitis;
- 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;
- A pathologically dry eye that precludes contact lens wear;
- 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;
- Monocular (only 1 eye with functional vision);
- Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear within 6 months prior to enrollment, as determined by the investigator;
- Concurrent participation in a contact lens or contact lens care product clinical trial within the previous 30 days;
- History of intolerance or hypersensitivity to any component of the investigational products;
- Corneal vascularization that is mild (Grade 2) or higher;
- History of corneal or refractive surgery, irregular cornea or unilateral pseudophakia;
- Biomicroscopy findings (except for corneal vascularization) that are moderate (Grade 3) or severe (Grade 4);
- Eye injury or ocular or intra-ocular surgery within 6 months prior to enrollment;
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;
- Other protocol-defined inclusion criteria may apply.
- Manifest cylinder less than or equal to 1.00 D;
- ...
- Current or previous soft contact lens wearer;
- Other protocol-defined inclusion criteria may apply.
- Manifest cylinder less than or equal to 1.00 D;
- Able to achieve best corrected visual acuity (BCVA) of 20/25 or better in each eye at distance (as determined by manifest refraction);
- Willing and able to wear multifocal contact lenses in both eyes within the available range of powers for this trial;
- Must sign an Informed Consent document;
- Presbyopic and require at least 2.25 diopters (D) spectacle ADD power;
- 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
- Clinically significant (> 1 millimeter) anisocoria;
- Anisometropia ≥ 1.50 D (contact lens distance prescription);
- Other protocol-defined exclusion criteria may apply.
- ...
- Clinically significant (> 1 millimeter) anisocoria;
- Anisometropia ≥ 1.50 D (contact lens distance prescription);
- Other protocol-defined exclusion criteria may apply.
- Any history of herpetic keratitis;
- 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;
- A pathologically dry eye that precludes contact lens wear;
- 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;
- Monocular (only 1 eye with functional vision);
- Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear within 6 months prior to enrollment, as determined by the investigator;
- Concurrent participation in a contact lens or contact lens care product clinical trial within the previous 30 days;
- History of intolerance or hypersensitivity to any component of the investigational products;
- Corneal vascularization that is mild (Grade 2) or higher;
- History of corneal or refractive surgery, irregular cornea or unilateral pseudophakia;
- Biomicroscopy findings (except for corneal vascularization) that are moderate (Grade 3) or severe (Grade 4);
- Eye injury or ocular or intra-ocular surgery within 6 months prior to enrollment;
Tracking Information
- NCT #
- NCT02117544
- Collaborators
- Not Provided
- Investigators
- Study Director: Sr. Clinical Manager, Vision Care, GCRA Alcon Research