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N/A Completed N=126 Randomized Double-blind Treatment

A Study to Evaluate the Feasibility of a High Add Multi Focal Contact Lens

Source: ClinicalTrials.gov NCT01518868 ↗
Enrolled (actual)
126
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcomePrimary: Visual Acuity — 0.079; 0.090 logMAR

Summary

The objective of this study is to evaluate the product performance of the investigational multifocal high add soft contact lens compared with PureVision Multi-focal contact lens on a daily wear basis.

Outcome Measures

OutcomeResultp-value
PRIMARY
Visual Acuity
0.079; 0.090
SECONDARY
Symptoms/Complaints
95.6; 92.5; 89.4; 81.5; 75.3; 64.9

Eligibility Criteria

Inclusion Criteria

  • Have physiologically normal anterior segments
  • Be adapted wearers of soft contact lenses and wear a lens in each eye.
  • Be presbyopic and require near add correction in each eye.
  • Be an adapted monovision or multifocal contact lens wearer or be an adapted spherical lens wearer who also uses spectacles for near vision correction.
  • Have no active ocular disease or allergic conjunctivitis.
  • Must not be using any topical ocular medications.
  • Must habitually use a lens care product for lens cleaning, disinfecting, and storage.

Exclusion Criteria

  • Any Grade 2 or greater finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
  • Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
  • Anisometropia (spherical equivalent) of greater than 2.00 D.
  • Any systemic disease affecting ocular health.
  • Using any systemic or topical medications that will affect ocular physiology or lens performance.
  • Allergic to any component in the study products.
  • Ocular astigmatism of greater than 1.00 D in either eye.
  • Have had any corneal surgery (ie, refractive surgery).
  • Uses AMO Ultra Care as their habitual lens care regimen.
  • Is a toric contact lens wearer.
  • Have worn gas permeable (GP) contact lenses within last 30 days or PMMA lenses within last 3 months.
  • An active ocular disease (for example but not limited to papillary conjunctivitis, any conjunctivitis: viral, bacterial, allergic), any corneal infiltrative response or are using any ocular medications.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01518868). 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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