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N/A Completed N=79 Randomized Single-blind Treatment

Clinical Evaluation of the Safety and Efficacy of a New Multifocal Contact Lens

Myopia · ametropia · Presbyopia · Refractive Error
Source: ClinicalTrials.gov NCT01797783 ↗
Enrolled (actual)
79
Serious AEs
0.0%
Results posted
May 2014
Primary outcomePrimary: Subjective Overall Vision — 8.7; 8.4; 8.4; 7.5 Units on a scale

Summary

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Subjective Overall Vision
8.7; 8.4; 8.4; 7.5; 8.6; 7.7
SECONDARY
Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses
5; 4; 4; 2; 0; 0
SECONDARY
Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses
0; 1; 1; 0; 1; 1

Eligibility Criteria

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01797783). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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