- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04091581
Comparison of Tear Evaporation Rate With Systane Complete in Dry Eye and Non-Dry Eye (BULLDOG)
June 1, 2022 updated by: University of Waterloo
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Waterloo, Ontario, Canada, N2L 3G1
- Centre for Ocular Research & Education
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Is at least 18 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;
- Is willing to be awake for at least 2 hours before visit 2;
- Is willing not to wear eye makeup on the day of visit 2;
- Is willing not to use eye drops or artificial tears on the days of visits 1 or 2;
Group specific criteria:
- Dry eye participant group: Symptoms: OSDI ≥ 13 and Signs: NIKBUT ≤ 5 s in the worst eye
- Non-dry eye participant group: Symptoms: OSDI < 13 and Signs: NIKBUT ≥ 10 s in the worst eye
Exclusion Criteria:
- 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 undergone ocular surgery in the last 6 months;
- Has punctal plugs;
- Has a known sensitivity to Systane eye drops (including Systane Balance, Systane Complete, Systane Gel Drops, Systane Ultra, etc.)
- Has a known sensitivity to petroleum jelly (Vaseline);
- Has epilepsy and/or sensitivity to flashing lights;
- Has worn contact lenses within the past month or is planning to wear contact lenses during the study;
- Has any physical impairment that would interfere with holding the evaporimeter;
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
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Systane Complete will be instilled and rate of evaporation assessed before and after.
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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
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Systane Complete will be instilled and rate of evaporation assessed before and after.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tear Evaporation Rate
Time Frame: Baseline (Prior to instillation); 10, 30 and 60 minutes post instillation of eye drop
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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.
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Baseline (Prior to instillation); 10, 30 and 60 minutes post instillation of eye drop
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 21, 2019
Primary Completion (Actual)
February 6, 2020
Study Completion (Actual)
February 6, 2020
Study Registration Dates
First Submitted
September 13, 2019
First Submitted That Met QC Criteria
September 16, 2019
First Posted (Actual)
September 17, 2019
Study Record Updates
Last Update Posted (Actual)
June 22, 2022
Last Update Submitted That Met QC Criteria
June 1, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 41327
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
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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