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N/A N=182 Randomized Single-blind Other

Assessing Fitting Guides in Alcon Multifocal Contact Lenses

Presbyopia · Refractive Errors

Enrolled (actual)
182
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcome: Primary: Mean Number of Trial Lenses Needed to Fit Each Eye — 1.2; 1.4 lenses

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Lotrafilcon B multifocal contact lenses (Device); Nelfilcon A multifocal contact lenses (Device); Delefilcon A multifocal contact lenses (Device)
Age
Adult, Older Adult · 40+ yrs
Sex
All
Sponsor
Alcon Research
Primary completion
Jul 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Mean Number of Trial Lenses Needed to Fit Each Eye
1.2; 1.4

Summary

The purpose of this study is to compare an alternative fitting guide to a current fitting guide for optimizing contact lens parameters and determining contact lens prescription.

Eligibility Criteria

Inclusion Criteria

  • Sign informed consent;
  • Normal eyes;
  • Current full-time soft contact lens wearer needing presbyopia correction;
  • Willing to wear lenses for a minimum of five days per week, six hours per day, and attend all study visits;
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

  • Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the Investigator;
  • Eye conditions (past or present) as specified in the protocol;
  • Currently wearing Alcon multifocal (MF) contact lenses;
  • Only one eye with functional vision;
  • Contact lens wear in one eye only;
  • Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study;
  • Other protocol-defined exclusion criteria may apply.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03118934). 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.

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