BULLDOG: Comparison of Tear Evaporation Rate With Systane Complete in Dry Eye and Non-Dry Eye

• Sponsor: University of Waterloo (Other)
• Overall Status: Completed
• CT.gov ID: NCT04091581
• Collaborator: (none)
• Enrollment: 21
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.5
• Patients Per Site Per Month: 8.3

Study Details

Study Description

Brief Summary

The objective of the study is to compare the rate of tear evaporation, measured with a novel evaporimeter, before and for one hour after an eye drop containing nano-sized oil droplets has been instilled.

Condition or Disease	Intervention/Treatment	Phase
Evaporative Dry Eye	Drug: Systane Complete	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Comparison of Tear Evaporation Rate With Systane Complete in Dry Eye and Non-Dry Eye
• Actual Study Start Date: Nov 21, 2019
• Actual Primary Completion Date: Feb 6, 2020
• Actual Study Completion Date: Feb 6, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Non-Dry Eye Instill eye drop and perform followup assessments on people with a Ocular Surface Disease Index score <13 and a non-invasive Keratograph break-up time of >/= 10 seconds in the worst eye	Drug: Systane Complete; Systane Complete will be instilled and rate of evaporation assessed before and after.
Experimental: Dry Eye Instill eye drop and perform followup assessments on people with an Ocular Surface Disease Index score >/= 13 and a non-invasive Keratograph break-up time </= 5 seconds in the worst eye	Drug: Systane Complete; Systane Complete will be instilled and rate of evaporation assessed before and after.

Outcome Measures

Primary Outcome Measures

1. Tear Evaporation Rate [Baseline (Prior to instillation); 10, 30 and 60 minutes post instillation of eye drop]

   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 right eye was analyzed.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Is at least 18 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. Is willing to be awake for at least 2 hours before visit 2;

5. Is willing not to wear eye makeup on the day of visit 2;

6. Is willing not to use eye drops or artificial tears on the days of visits 1 or 2;

7. Group specific criteria:

8. Dry eye participant group: Symptoms: OSDI ≥ 13 and Signs: NIKBUT ≤ 5 s in the worst eye

9. Non-dry eye participant group: Symptoms: OSDI < 13 and Signs: NIKBUT ≥ 10 s in the worst eye

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 undergone ocular surgery in the last 6 months;

10. Has punctal plugs;

11. Has a known sensitivity to Systane eye drops (including Systane Balance, Systane Complete, Systane Gel Drops, Systane Ultra, etc.)

12. Has a known sensitivity to petroleum jelly (Vaseline);

13. Has epilepsy and/or sensitivity to flashing lights;

14. Has worn contact lenses within the past month or is planning to wear contact lenses during the study;

15. Has any physical impairment that would interfere with holding the evaporimeter;

16. Has taken part in another clinical research study involving ocular drops or treatments within the last 14 days; * For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

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

• Principal Investigator: Lyndon Jones, PhD, FCOptom, Centre for Ocular Research & Education

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 31, 2019

More Information

Publications

None provided.

• Responsible Party: University of Waterloo
• ClinicalTrials.gov Identifier: NCT04091581
• Other Study ID Numbers: 41327
• First Posted: Sep 17, 2019
• Last Update Posted: Jun 22, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca

Study Results

Participant Flow

Recruitment Details	Participants were recruited from a single study center located in Canada.

Arm/Group Title	Non-Dry Eye	Dry Eye
Arm/Group Description	Tear evaporation was measured prior to and after a single 15 µl instillation of Systane Complete was instilled in people with an Ocular Surface Disease Index score <13 and a non-invasive Keratograph break-up time >/= 10 seconds in the worst eye.	Tear evaporation was measured prior to and after a single 15 µl instillation of Systane Complete in people with an Ocular Surface Disease Index score >/= 13 and a non-invasive Keratograph break-up time </= 5 seconds in the worst eye.
Period Title: Overall Study
STARTED	10	11
COMPLETED	10	10
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Non-Dry Eye	Dry Eye	Total
Arm/Group Description	Tear evaporation was measured prior to and after Systane Complete was instilled.	Tear evaporation was measured prior to and after Systane Complete was instilled.	Total of all reporting groups
Overall Participants	10	11	21
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32.6 (12.8)	45.4 (22.7)	39.3 (19.4)
Sex: Female, Male (Count of Participants)
Female	7 70%	10 90.9%	17 81%
Male	3 30%	1 9.1%	4 19%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
Canada	10 100%	11 100%	21 100%

Outcome Measures

1. Primary Outcome

Title	Tear Evaporation Rate
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 right eye was analyzed.
Time Frame	Baseline (Prior to instillation); 10, 30 and 60 minutes post instillation of eye drop

Outcome Measure Data

Analysis Population Description

The analysis population includes all participants that were exposed to Systane Complete, and excludes the one dry eye subject that was lost to follow-up.

Arm/Group Title	Non-Dry Eye	Dry Eye
Arm/Group Description	Tear evaporation was measured prior to and after Systane Complete was instilled in people without dry eye.	Tear evaporation was measured prior to and after Systane Complete was instilled in people with dry eye.
Measure Participants	10	10
Baseline	1.15 (0.19)	1.38 (0.22)
10 minutes post-drop	1.26 (0.31)	1.32 (0.25)
30 minutes post-drop	1.01 (0.24)	1.18 (0.27)
60 minutes post-drop	1.07 (0.31)	1.27 (0.27)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Non-Dry Eye
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	ANOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Non-Dry Eye, Dry Eye
	Comments	Comparison of the baseline tear evaporation rate of the non-dry eye and dry eye group.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.022
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	Adverse events were collected from the time of consent for the duration of the study (up to 2 weeks). Adverse events are reported as pre-treatment or post-treatment.
Adverse Event Reporting Description	An adverse event was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, whether or not related to the medical device.
Arm/Group Title	Non-Dry Eye		Dry Eye
Arm/Group Description	Tear evaporation was measured prior to and after Systane Complete was instilled in a group of people without dry eye that had an Ocular Surface Disease Index score <13 and a non-invasive Keratograph break-up time >/= 10 seconds in the worst eye.		Tear evaporation was measured prior to and after Systane Complete was instilled in a group of people with dry eye that had an Ocular Surface Disease Index score >/=13 and a non-invasive Keratograph break-up time </= 5 seconds in the worst eye.
All Cause Mortality
	Non-Dry Eye		Dry Eye
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/10 (10%)		2/11 (18.2%)
Serious Adverse Events
	Non-Dry Eye		Dry Eye
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/11 (0%)
Other (Not Including Serious) Adverse Events
	Non-Dry Eye		Dry Eye
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/10 (10%)		2/11 (18.2%)
Infections and infestations
Fever	0/10 (0%)	0	1/11 (9.1%)	1
Common cold	1/10 (10%)	1	0/11 (0%)	0
Surgical and medical procedures
Steroid injection	0/10 (0%)	0	1/11 (9.1%)	1

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.