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

• Sponsor: University of Waterloo (Other)
• Overall Status: Completed
• CT.gov ID: NCT04037969
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.6
• Patients Per Site Per Month: 5.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Evaporative Dry Eye	Device: Nesofilcon A; Device: Delefilcon A	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Masking Description: Participants and investigators are masked as to which lens is assigned to each eye.
• Primary Purpose: Diagnostic
• Official Title: Comparison of Tear Evaporation Rate With DAILIES TOTAL1 and Biotrue ONEday
• Actual Study Start Date: Aug 7, 2019
• Actual Primary Completion Date: Nov 26, 2019
• Actual Study Completion Date: Nov 26, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Tear Evaporation Rate With Nesofilcon A [Baseline, 15 minutes post-contact lens, 6 hours post-contact lens]

   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.

2. Tear Evaporation Rate With Delefilcon A [Baseline, 15 minutes post-contact lens, 6 hours post-contact lens]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 17 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre for Ocular Research & Education	Waterloo	Ontario	Canada	N2L 3G1

Sponsors and Collaborators

• University of Waterloo

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 24, 2019

More Information

Publications

None provided.

• Responsible Party: University of Waterloo
• ClinicalTrials.gov Identifier: NCT04037969
• Other Study ID Numbers: 41195
• First Posted: Jul 30, 2019
• Last Update Posted: Apr 23, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Dry Eye Syndromes

Study Results

Participant Flow

Arm/Group Title	Nesofilcon A/Delefilcon A	Delefilcon A/Nesofilcon A
Arm/Group Description	Nesofilcon A randomly assigned to one eye with delefilcon A in the fellow eye. Nesofilcon A: Hydrogel contact lens for daily wear	Delefilcon A randomly assigned to one eye with nesofilcon A in the fellow eye. Delefilcon A: Silicone hydrogel contact lens for daily wear
Period Title: Overall Study
STARTED	10	10
COMPLETED	10	10
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Nesofilcon A/Delefilcon A	Delefilcon A/Nesofilcon A	Total
Arm/Group Description	Nesofilcon A randomly assigned to one eye with delefilcon A in the fellow eye. Nesofilcon A: Hydrogel contact lens for daily wear	Delefilcon A randomly assigned to one eye with nesofilcon A in the fellow eye. Delefilcon A: Silicone hydrogel contact lens for daily wear	Total of all reporting groups
Overall Participants	10	10	20
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	9 90%	10 100%	19 95%
>=65 years	1 10%	0 0%	1 5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31.2 (17.1)	25.1 (9.6)	28.2 (13.9)
Sex: Female, Male (Count of Participants)
Female	9 90%	10 100%	19 95%
Male	1 10%	0 0%	1 5%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
Canada	10 100%	10 100%	20 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Full Group
Arm/Group Description	Delefilcon A was worn in a randomly assigned eye and Nesofilcon A was worn in the fellow eye. Nesofilcon A: Hydrogel contact lens for daily wear Delefilcon A: Silicone hydrogel contact lens for daily wear
Measure Participants	20
Baseline	0.81 (0.30)
15 minutes post-contact lenses	0.88 (0.32)
6 hours post-contact lenses	0.92 (0.38)

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Full Group
Arm/Group Description	Delefilcon A was worn in a randomly assigned eye and Nesofilcon A was worn in the fellow eye. Nesofilcon A: Hydrogel contact lens for daily wear Delefilcon A: Silicone hydrogel contact lens for daily wear
Measure Participants	20
Baseline	0.74 (0.21)
15 minutes post-contact lenses	0.87 (0.24)
6 hours post-contact lenses	0.95 (0.30)

Adverse Events

Time Frame	One day
Arm/Group Title	Nesofilcon A/Delefilcon A		Delefilcon A/Nesofilcon A
Arm/Group Description	Nesofilcon A randomly assigned to one eye with delefilcon A in the fellow eye. Nesofilcon A: Hydrogel contact lens for daily wear		Delefilcon A randomly assigned to one eye with nesofilcon A in the fellow eye. Delefilcon A: Silicone hydrogel contact lens for daily wear
All Cause Mortality
	Nesofilcon A/Delefilcon A		Delefilcon A/Nesofilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Serious Adverse Events
	Nesofilcon A/Delefilcon A		Delefilcon A/Nesofilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Nesofilcon A/Delefilcon A		Delefilcon A/Nesofilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.