NCT Number: NCT01797783
Clinical Evaluation of the Safety and Efficacy of a New Multifocal Contact Lens
The purpose of this study was to demonstrate substantial equivalence of the new DAILIES® AquaComfort Plus® Multifocal (DACP MF) contact lens to the commercially available Focus® DAILIES® Progressives (FDP) contact lens.
Looking for future studies?
Notify MeKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Sign Informed Consent Document.
- Presbyopic and require a spectacle add of up to and including 3.00 diopters (D).
- Currently wear soft contact lenses.
- Willing and able to wear multifocal contact lenses in both eyes within the available range of powers for this trial and comply with the wearing and replacement schedule.
- Manifest cylinder less than or equal to 1.00 D.
- Able to achieve best corrected visual acuity (BCVA) of 20/25 or better (Snellen) in each eye at distance (as determined by manifest refraction).
- Able to achieve distance visual acuity of 20/40 (Snellen) or better in each eye with study lenses and deem subjective vision as satisfactory at time of dispense.
- 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.
- Any use of systemic or ocular medications for which contact lens wear could be contraindicated.
- History of corneal or refractive surgery.
- Biomicroscopy findings greater than Grade 2 at baseline.
- A pathologically dry eye that precludes contact lens wear.
- Monocular (only one eye with functional vision).
- Wear habitual contact lenses on an extended wear schedule (any number of nights of overnight wear on a regular basis).
- 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 or within the previous 30 days.
- Eye injury or ocular or intra-ocular surgery within 6 months prior to enrollment.
- Other protocol-defined exclusion criteria may apply.
Treatment and study plan
Nelfilcon A multifocal contact lens
DevicePrimary outcomes
-
Subjective Overall Vision
Time frame: Up to Day 30
The participant was instructed to, "Please rate the aggregate of distance, intermediate, and near vision quality. Fill in the circle below the number that indicates your selection. Rate eyes together, marking only 1 circle for both eyes. Higher numbers mean better vision." The response was recorded on a continuous scale from 1-10 (1=poor, 10=excellent).
Secondary outcomes
-
Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses
Time frame: Up to Day 30
Visual Acuity was tested while reading a chart at 20-foot equivalent distance from the participant with both eyes together. The Snellen fraction compares the participant's result to the result expected from the 'normal' visual system. The numerator represents the distance between the participant and the chart, and the denominator represents the distance at which a person with 'normal' vision would be able to discern the same letter size. 20/20 is considered to be 'normal' vision, whereas visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity.
-
Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses
Time frame: Up to Day 30
Visual Acuity was tested while reading charts at a distance of 40 cm from the participant with both eyes together. The Snellen fraction 20/20 represents 'normal' near vision. A larger denominator indicates a lower visual acuity.
Sponsors and collaborators
Lead sponsor
Alcon Research
Industry
Registry information
Important dates
- Study start
- 2013
- Primary completion
- 2013
- Study completion
- 2013
- First posted
- Feb 25, 2013
- Registry last updated
- May 23, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Apioc Contact Lens Feasibility
NCT03688672
Ametropia, Astigmatism
Columbus, Ohio, United States
View Trial DetailsSafety and Efficacy Study to Evaluate the Treatment of Both Near and Distance Vision in a Simultaneous Laser Procedure
NCT01322919
Eye Diseases, Hyperopia
Monterrey, N.l., Mexico
View Trial DetailsSilicone Hydrogel Contact Lens Clinical and Comfort Benefits With a Multi-Purpose Disinfecting Solution
NCT01809197
Astigmatism, Eye Diseases
View Trial DetailsClinical Trial With Artiflex Presbyopic (Artiplus)
NCT04632784
Ametropia, Eye Diseases
Busan, South Korea
View Trial Details