search
Back to results

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

Primary Purpose

Evaporative Dry Eye

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Nesofilcon A
Delefilcon A
Sponsored by
University of Waterloo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Evaporative Dry Eye

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Centre for Ocular Research & Education

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Nesofilcon A/Delefilcon A

Delefilcon A/Nesofilcon A

Arm Description

Nesofilcon A was worn in right eye and delefilcon A worn in the left eye.

Delefilcon A was worn in right eye and Nesofilcon A worn in the left eye.

Outcomes

Primary Outcome Measures

Tear Evaporation Rate With Nesofilcon A
Tear film evaporation rate (% relative humidity per second) was performed using a novel evaporimeter as a non-invasive measurement of tear film evaporation. The slope was calculated from the change in humidity between 7 to 17.5 seconds while the eye was open and between 10 to 17.5 seconds when the eye was closed. Data from the both eyes were analyzed.
Tear Evaporation Rate With Delefilcon A
Tear film evaporation rate (% relative humidity per second) was performed using a novel evaporimeter as a non-invasive measurement of tear film evaporation. The slope was calculated from the change in humidity between 7 to 17.5 seconds while the eye was open and between 10 to 17.5 seconds when the eye was closed. Data from the both eyes were analyzed.

Secondary Outcome Measures

Full Information

First Posted
July 26, 2019
Last Updated
March 25, 2021
Sponsor
University of Waterloo
search

1. Study Identification

Unique Protocol Identification Number
NCT04037969
Brief Title
Comparison of Tear Evaporation Rate With DAILIES TOTAL1 and Biotrue ONEday
Acronym
MALTESE
Official Title
Comparison of Tear Evaporation Rate With DAILIES TOTAL1 and Biotrue ONEday
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
August 7, 2019 (Actual)
Primary Completion Date
November 26, 2019 (Actual)
Study Completion Date
November 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Waterloo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Evaporative Dry Eye

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Participants and investigators are masked as to which lens is assigned to each eye.
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nesofilcon A/Delefilcon A
Arm Type
Experimental
Arm Description
Nesofilcon A was worn in right eye and delefilcon A worn in the left eye.
Arm Title
Delefilcon A/Nesofilcon A
Arm Type
Experimental
Arm Description
Delefilcon A was worn in right eye and Nesofilcon A worn in the left eye.
Intervention Type
Device
Intervention Name(s)
Nesofilcon A
Intervention Description
Hydrogel contact lens for daily wear
Intervention Type
Device
Intervention Name(s)
Delefilcon A
Intervention Description
Silicone hydrogel contact lens for daily wear
Primary Outcome Measure Information:
Title
Tear Evaporation Rate With Nesofilcon A
Description
Tear film evaporation rate (% relative humidity per second) was performed using a novel evaporimeter as a non-invasive measurement of tear film evaporation. The slope was calculated from the change in humidity between 7 to 17.5 seconds while the eye was open and between 10 to 17.5 seconds when the eye was closed. Data from the both eyes were analyzed.
Time Frame
Baseline, 15 minutes post-contact lens, 6 hours post-contact lens
Title
Tear Evaporation Rate With Delefilcon A
Description
Tear film evaporation rate (% relative humidity per second) was performed using a novel evaporimeter as a non-invasive measurement of tear film evaporation. The slope was calculated from the change in humidity between 7 to 17.5 seconds while the eye was open and between 10 to 17.5 seconds when the eye was closed. Data from the both eyes were analyzed.
Time Frame
Baseline, 15 minutes post-contact lens, 6 hours post-contact lens

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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; Has worn soft contact lenses for a minimum of 6 months; Currently wears soft contact lenses for at least 4 days per week and 8 hours per day; Has an acceptable fit and comfort with both study contact lenses in the powers available; Has less than or equal to 1.00DS difference between eyes in their habitual contact lenses; Is willing to be awake for at least 2 hours before visit 2; Is willing to not wear eye makeup on the day of visit 2 and 3; Is willing to not use eye drops or artificial tears on the day of visits 1, 2, and 3; Has a wearable pair of spectacles. Exclusion Criteria: Is participating in any concurrent clinical or research study; 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 sodium fluorescein dye; 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 a known sensitivity to petroleum jelly (Vaseline); Has epilepsy and/or a sensitivity to flashing lights; Wears toric contact lenses; Has any physical impairment that would interfere with holding the evaporimeter; Has taken part in another research study within the last 14 days.
Facility Information:
Facility Name
Centre for Ocular Research & Education
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison of Tear Evaporation Rate With DAILIES TOTAL1 and Biotrue ONEday

We'll reach out to this number within 24 hrs