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Comparison of Tear Evaporation Rate With DAILIES TOTAL1 and Biotrue ONEday (MALTESE)

U

University of Waterloo

Status

Completed

Conditions

Evaporative Dry Eye

Treatments

Device: Nesofilcon A
Device: Delefilcon A

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

The purpose of this pilot study is to compare the effect of DAILIES TOTAL1, a low water content silicone hydrogel lens, and Biotrue ONEday, a high water content hydrogel lens, on the rate of tear evaporation. The study will also serve to validate the novel, in-house developed evaporimeter.

Enrollment

20 patients

Sex

All

Ages

17+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Is at least 17 years of age and has full legal capacity to volunteer;
  2. Has read and signed an information consent letter;
  3. Is willing and able to follow instructions and maintain the appointment schedule;
  4. Has worn soft contact lenses for a minimum of 6 months;
  5. Currently wears soft contact lenses for at least 4 days per week and 8 hours per day;
  6. Has an acceptable fit and comfort with both study contact lenses in the powers available;
  7. Has less than or equal to 1.00DS difference between eyes in their habitual contact lenses;
  8. Is willing to be awake for at least 2 hours before visit 2;
  9. Is willing to not wear eye makeup on the day of visit 2 and 3;
  10. Is willing to not use eye drops or artificial tears on the day of visits 1, 2, and 3;
  11. Has a wearable pair of spectacles.

Exclusion criteria

  1. Is participating in any concurrent clinical or research study;
  2. Has any known active* ocular disease and/or infection;
  3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
  4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
  5. Has known sensitivity to sodium fluorescein dye;
  6. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
  7. Is aphakic;
  8. Has undergone refractive error surgery;
  9. Has a known sensitivity to petroleum jelly (Vaseline);
  10. Has epilepsy and/or a sensitivity to flashing lights;
  11. Wears toric contact lenses;
  12. Has any physical impairment that would interfere with holding the evaporimeter;
  13. Has taken part in another research study within the last 14 days.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

20 participants in 2 patient groups

Nesofilcon A/Delefilcon A
Experimental group
Description:
Nesofilcon A was worn in right eye and delefilcon A worn in the left eye.
Treatment:
Device: Nesofilcon A
Device: Delefilcon A
Delefilcon A/Nesofilcon A
Experimental group
Description:
Delefilcon A was worn in right eye and Nesofilcon A worn in the left eye.
Treatment:
Device: Nesofilcon A
Device: Delefilcon A

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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