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

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CooperVision

Status

Completed

Conditions

Astigmatism

Treatments

Device: samfilcon A toric lens
Device: comfilcon A toric lens

Study type

Interventional

Funder types

Industry

Identifiers

NCT03519932
EX-MKTG-91

Details and patient eligibility

About

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

Enrollment

49 patients

Sex

All

Ages

17+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

49 participants in 2 patient groups

comfilcon A toric lens
Experimental group
Description:
Subjects who wear comfilcon A toric lens either as first or second pair during this cross-over study.
Treatment:
Device: comfilcon A toric lens
Device: samfilcon A toric lens
samfilcon A toric lens
Active Comparator group
Description:
Subjects who wear samfilcon A toric lens either as first or second pair during this cross-over study.
Treatment:
Device: comfilcon A toric lens
Device: samfilcon A toric lens

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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