Comparison of Tear Evaporation Rate With DAILIES TOTAL1 and Biotrue ONEday

NCT04037969 | Completed Results FDA Device

• 1 other identifier: 41195
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Evaporative Dry Eye

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Nesofilcon A/Delefilcon A

EXPERIMENTAL

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

Device: Nesofilcon A; Device: Delefilcon A

Delefilcon A/Nesofilcon A

EXPERIMENTAL

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

Device: Nesofilcon A; Device: Delefilcon A

Interventions

Nesofilcon A DEVICE

Hydrogel contact lens for daily wear

Delefilcon A/Nesofilcon A; Nesofilcon A/Delefilcon A

Delefilcon A DEVICE

Silicone hydrogel contact lens for daily wear

Delefilcon A/Nesofilcon A; Nesofilcon A/Delefilcon A

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Waterloo: lead

Study Sites (1)

Centre for Ocular Research & Education

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Jill Woods
• Organization: Centre for Ocular Research and Education

jwoods@uwaterloo.ca

5198884567

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants and investigators are masked as to which lens is assigned to each eye.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2019
• First Posted: July 30, 2019
• Study Start: August 7, 2019
• Primary Completion: November 26, 2019
• Study Completion: November 26, 2019
• Last Updated: April 23, 2021
• Results First Posted: April 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)