Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Multifocal High ADD Contact Lens Proof of Concept Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02117544
Recruitment Status : Completed
First Posted : April 21, 2014
Results First Posted : August 17, 2015
Last Update Posted : August 26, 2015
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief 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.

Condition or disease Intervention/treatment Phase
Presbyopia Device: Lotrafilcon B multifocal contact lenses (new) Device: Lotrafilcon B multifocal contact lenses Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 268 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Visual Performance With a Multifocal High ADD Soft Contact Lens Design
Study Start Date : April 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
New MF, then AOAMF
Lotrafilcon B multifocal contact lenses (new), followed by lotrafilcon B multifocal contact lenses. Each product worn bilaterally (in both eyes) for about 1 hour.
Device: Lotrafilcon B multifocal contact lenses (new)
Device: Lotrafilcon B multifocal contact lenses
Other Names:
  • AIR OPTIX® AQUA Multifocal
  • AOAMF

AOAMF, then New MF
Lotrafilcon B multifocal contact lenses, followed by lotrafilcon B multifocal contact lenses (new). Each product worn bilaterally (in both eyes) for about 1 hour.
Device: Lotrafilcon B multifocal contact lenses (new)
Device: Lotrafilcon B multifocal contact lenses
Other Names:
  • AIR OPTIX® AQUA Multifocal
  • AOAMF




Primary Outcome Measures :
  1. High Contrast Visual Acuity (HCVA) Near Monocular [ Time Frame: Day 1, 10 minutes after lens insertion, each product ]
    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.


Secondary Outcome Measures :
  1. HCVA Distance Monocular [ Time Frame: Day 1, 10 minutes after lens insertion, each product ]
    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.

  2. HCVA Intermediate Monocular [ Time Frame: Day 1, 10 minutes after lens insertion, each product ]
    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.

  3. Low Contrast Visual Acuity (LCVA) Distance Monocular [ Time Frame: Day 1, 10 minutes after lens insertion, each product ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02117544


Sponsors and Collaborators
Alcon Research
Investigators
Layout table for investigator information
Study Director: Sr. Clinical Manager, Vision Care, GCRA Alcon Research

Layout table for additonal information
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT02117544     History of Changes
Other Study ID Numbers: C-13-057
First Posted: April 21, 2014    Key Record Dates
Results First Posted: August 17, 2015
Last Update Posted: August 26, 2015
Last Verified: August 2015
Keywords provided by Alcon Research:
Contact lens
Presbyopia
Multifocal
Additional relevant MeSH terms:
Layout table for MeSH terms
Presbyopia
Refractive Errors
Eye Diseases