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CompletedNCT04091581BULLDOGUpdated Jun 22, 2022Results posted

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

A Phase 4 interventional study of Systane Complete in Evaporative Dry Eye, sponsored by University of Waterloo. Completed at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-22.

Sponsored by University of Waterloo · Phase 4, Interventional, and Diagnostic

Phase
Phase 4
Study type
Interventional
Enrollment
21
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Evaporative Dry Eye
03

In context

Dry Eye Syndromes

1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.

This study's enrollment of 21 is below the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

University of Waterloo is the lead sponsor of 90 studies on the registry; 8 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 9 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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:

    1. Dry eye participant group: Symptoms: OSDI ≥ 13 and Signs: NIKBUT ≤ 5 s in the worst eye
    2. Non-dry eye participant group: Symptoms: OSDI \< 13 and Signs: NIKBUT ≥ 10 s in the worst eye

Exclusion criteria

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.
05

Study design

Phase
Phase 4
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugSystane Complete

    Systane Complete will be instilled and rate of evaporation assessed before and after.

06

What researchers measure

Primary outcomes

  1. Tear Evaporation Rate

    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

07

Results

Posted Jun 22, 2022

Participant flow

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

Participant flow — Overall Study
MilestoneNon-Dry EyeDry Eye
Started1011
Completed1010
Not completed01
Withdrew: Lost to follow-up01

Outcome measures

PrimaryTear Evaporation Rate

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
Reported as:
Mean · % relative humidity per second
Tear Evaporation Rate
% relative humidity per secondNon-Dry EyeDry Eye
Baseline1.15 ± 0.191.38 ± 0.22
10 minutes post-drop1.26 ± 0.311.32 ± 0.25
30 minutes post-drop1.01 ± 0.241.18 ± 0.27
60 minutes post-drop1.07 ± 0.311.27 ± 0.27
Statistical analysis
  • Non-Dry Eye · ANOVA · p = 0.002
  • Non-Dry Eye vs Dry Eye · t-test, 2 sided · p = 0.022

Adverse events

Collected over 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.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Non-Dry Eye1/10 (10%)0/10 (0%)1/10 (10%)
Dry Eye2/11 (18.2%)0/11 (0%)2/11 (18.2%)
Most frequent other events
Most frequent other events
EventNon-Dry EyeDry Eye
Common coldInfections and infestations1/100/11
FeverInfections and infestations0/101/11
Steroid injectionSurgical and medical procedures0/101/11

Baseline characteristics

Age, Continuous
Age, Continuous(years)Non-Dry EyeDry EyeTotal
Mean32.6 ± 12.845.4 ± 22.739.3 ± 19.4
Sex: Female, Male
Sex: Female, Male(Participants)Non-Dry EyeDry EyeTotal
Female71017
Male314
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Non-Dry EyeDry EyeTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(participants)Non-Dry EyeDry EyeTotal
Canada101121
08

Study locations

1 site
  • Centre for Ocular Research & Education
    Waterloo, Ontario N2L 3G1, Canada
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Jul 31, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04091581
Lead sponsor
University of Waterloo
Responsible party
Sponsor
First posted
Sep 17, 2019
Start date
Nov 21, 2019
Primary completion
Feb 6, 2020
Completion
Feb 6, 2020
Results posted
Jun 22, 2022
Last update
Jun 22, 2022

Study contacts

Lyndon Jones, PhD, FCOptom
principal investigator · Centre for Ocular Research & Education

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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