Mode
Text Size
Log in / Sign up
N/A Completed N=49 Randomized Double-blind Treatment

A Dispensing Clinical of Fanfilcon A Lens Against Lotrafilcon B Lens Over 1 Month Wear Per Lens

Source: ClinicalTrials.gov NCT02716298 ↗
Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Subjective Comfort — 10; 9; 10; 9 units on a scale

Summary

This is a study to evaluate the performance of fanfilcon A lens when worn on a daily wear modality over approximately 1 month in comparison to the lotrafilcon B lens.

Outcome Measures

OutcomeResultp-value
PRIMARY
Subjective Comfort
10; 9; 10; 9; 9; 8 —
PRIMARY
Subjective Preference
52; 16; 9; 16; 7; 43 —
PRIMARY
Lens Wettability
0.76; 0.56; 0.85; 1.08 —
PRIMARY
Surface Deposits
0.14; 0.26; 0.34; 0.41 —

Eligibility Criteria

Inclusion Criteria

A person is eligible for inclusion in the study if he/she:

  • Is at least 17 years of age and has full legal capacity to volunteer;
  • Has read and signed an information consent letter;
  • Is willing and able to follow instructions and maintain the appointment schedule;
  • Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual correction and the assigned study lenses;
  • Is an adapted soft contact lens wearer (For the purpose of this study: Current lens wear at least 3 days per week, 8 hours each day);
  • Demonstrates an acceptable fit with the study lenses.

Exclusion Criteria

A person will be excluded from the study if he/she:

  • Is participating in any concurrent clinical or research study;
  • Is a habitual wearer of lotrafilcon B or enfilcon A lenses.
  • Has any known active* ocular disease and/or infection;
  • Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
  • Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
  • Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
  • Is pregnant, lactating or planning a pregnancy at the time of enrollment; (by verbal confirmation at the Screening Visit)
  • Is aphakic;
  • Has undergone refractive error surgery;
  • For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02716298). 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.

Back to search