Multifocal High ADD Contact Lens Proof of Concept Trial

Presbyopia Clinical Trial

Official title:

Evaluation of Visual Performance With a Multifocal High ADD Soft Contact Lens Design

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02117544
• Other study ID #: C-13-057
• Status: Completed
• Phase: N/A
• First received: April 16, 2014
• Last updated: August 14, 2015
• Start date: April 2014
• Est. completion date: July 2014

Study information

• Verified date: August 2015
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the visual performance of a new multifocal High ADD contact lens compared to the currently-marketed AIR OPTIX® AQUA MULTIFOCAL (AOAMF) High ADD Contact Lens.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 268
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Must sign an Informed Consent document;

• Presbyopic and require at least 2.25 diopters (D) spectacle ADD power;

• Current or previous soft contact lens wearer;

• 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;

• Willing and able to wear multifocal contact lenses in both eyes within the available range of powers for this trial;

• 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);

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear within 6 months prior to enrollment, as determined by the investigator;

• 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;

• Any history of herpetic keratitis;

• 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);

• Corneal vascularization that is mild (Grade 2) or higher;

• A pathologically dry eye that precludes contact lens wear;

• Monocular (only 1 eye with functional vision);

• Anisometropia = 1.50 D (contact lens distance prescription);

• Clinically significant (> 1 millimeter) anisocoria;

• History of intolerance or hypersensitivity to any component of the investigational products;

• 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;

• 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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Presbyopia

Intervention

Device:
• Lotrafilcon B multifocal contact lenses (new)

• Lotrafilcon B multifocal contact lenses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	High Contrast Visual Acuity (HCVA) Near Monocular	Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 40 centimeters using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.	Day 1, 10 minutes after lens insertion, each product	No
Secondary	HCVA Distance Monocular	Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 6 meters using an ETDRS chart and measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.	Day 1, 10 minutes after lens insertion, each product	No
Secondary	HCVA Intermediate Monocular	Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 1 meter using an ETDRS chart and measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.	Day 1, 10 minutes after lens insertion, each product	No
Secondary	Low Contrast Visual Acuity (LCVA) Distance Monocular	Visual Acuity (clarity or sharpness of vision) was measured at low contrast level. LCVA was assessed monocularly (each eye separately) at 6 meters using an ETDRS chart and measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.	Day 1, 10 minutes after lens insertion, each product	No