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

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.

Study Overview

• Status: Completed
• Conditions: Evaporative Dry Eye
• Intervention / Treatment: Device: Nesofilcon A; Device: Delefilcon A

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3G1
      • Centre for Ocular Research & Education

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nesofilcon A/Delefilcon A; Nesofilcon A was worn in right eye and delefilcon A worn in the left eye.	Device: Nesofilcon A; Hydrogel contact lens for daily wear; Device: Delefilcon A; Silicone hydrogel contact lens for daily wear
Experimental: Delefilcon A/Nesofilcon A; Delefilcon A was worn in right eye and Nesofilcon A worn in the left eye.	Device: Nesofilcon A; Hydrogel contact lens for daily wear; Device: Delefilcon A; Silicone hydrogel contact lens for daily wear

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 15 minutes post-contact lens, 6 hours post-contact lens
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.	Baseline, 15 minutes post-contact lens, 6 hours post-contact lens

Collaborators and Investigators

• Sponsor: University of Waterloo

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2019
• Primary Completion (Actual): November 26, 2019
• Study Completion (Actual): November 26, 2019

Study Registration Dates

• First Submitted: July 26, 2019
• First Submitted That Met QC Criteria: July 26, 2019
• First Posted (Actual): July 30, 2019

Study Record Updates

• Last Update Posted (Actual): April 23, 2021
• Last Update Submitted That Met QC Criteria: March 25, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: 41195

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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