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N/A Completed N=49 Randomized Double-blind Treatment

Comparison of Comfilcon A Toric Contact Lenses and Samfilcon A Toric Contact Lenses

Astigmatism
Source: ClinicalTrials.gov NCT03519932 ↗
Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcomePrimary: Comfort at Insertion — 9.0; 8.8 units on a scale

Summary

The objective of this study is to evaluate the subjective acceptance of comfilcon A toric contact lens, compared to samfilcon A toric lens.

Outcome Measures

OutcomeResultp-value
PRIMARY
Comfort at Insertion
9.0; 8.8 —
PRIMARY
Comfort
8.1; 7.4; 7.1; 6.7 —
PRIMARY
Lens Preference Based on Overall Comfort
44; 27; 7; 7; 16 —
PRIMARY
Lens Preference Based on Overall Dryness
29; 33; 16; 4; 18 —
PRIMARY
Dryness
7.5; 6.7; 6.6; 6.2 —
SECONDARY
Ease of Insertion
9.0; 8.3 —
SECONDARY
Ease of Removal
8.0; 8.5 —

Eligibility Criteria

Inclusion Criteria

  • Is at least 17 years of age and has full legal capacity to volunteer;
  • Has had a self-reported oculo-visual examination in the last two years.
  • Has read and signed an information consent letter;
  • Is willing and able to follow instructions and maintain the appointment schedule;
  • Is an adapted soft contact lens wearer, who currently wears contact lenses for a minimum 3 days/week and 8 hours/day AND who anticipates no difficulty wearing CLs for 6 days/week, 10 hours /day.
  • Is willing to wear contact lens in both eyes for the duration of the study;
  • Has a minimum astigmatism of - 0.75, determined by refraction;
  • Can be fit with the two study contact lens types in the powers available;
  • Has a distance visual acuity of 0.20 logMAR (approx 20/30) or better, determined by refraction;
  • Can achieve a distance visual acuity of 0.20 logMAR (approx 20/30) or better in each eye with the study contact lenses.
  • Has clear corneas and no active* ocular disease

Exclusion Criteria

  • Is participating in any concurrent clinical trial;
  • Has any known active* ocular disease and/or infection;
  • Has a systemic condition that in the opinion of the investigator may affect a study measure;
  • Is using any systemic or topical medications that in the opinion of the investigator may affect a study measure;
  • Has known sensitivity to fluorescein dye or products to be used in the study;
  • Appears to have any active* ocular pathology, ocular anomaly or severe insufficiency of lacrimal secretion (severe dry eye) that would affect the wearing of contact lenses;
  • Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
  • Is aphakic;
  • Has undergone refractive error surgery.
  • Has participated in the PIANO (i.e. EX-MKTG-83) Study.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03519932). 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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