Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04091581
Recruitment Status : Not yet recruiting
First Posted : September 17, 2019
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
University of Waterloo

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group 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
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : March 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
Drug Information available for: Systane

Arm Intervention/treatment
Experimental: Assessment
Instill eye drop and perform followup assessments
Drug: Systane Complete
Systane Complete will be instilled and rate of evaporation assessed before and after.




Primary Outcome Measures :
  1. Change in Tear evaporation rate [ Time Frame: Baseline (Prior to instillation); 10, 30 and 60 minutes post instillation ]
    Slope of best fit line for the graph of change in relative humidity over time during a 20 second measurement of the eye after instillation of Systane Complete as compared to that prior to instillation.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04091581


Contacts
Layout table for location contacts
Contact: Jill Woods, MCOptom 519-888-4567 ext 36743 jwoods@uwaterloo.ca

Locations
Layout table for location information
Canada, Ontario
Centre for Ocular Research & Education Not yet recruiting
Waterloo, Ontario, Canada, N2L 3G1
Contact: Jill Woods, MCOptom    519-888-4567 ext 36743    jwoods@uwaterloo.ca   
Principal Investigator: Lyndon Jones, PhD, FCOptom         
Sponsors and Collaborators
University of Waterloo
Investigators
Layout table for investigator information
Principal Investigator: Lyndon Jones, PhD, FCOptom Centre for Ocular Research & Education

Layout table for additonal information
Responsible Party: University of Waterloo
ClinicalTrials.gov Identifier: NCT04091581     History of Changes
Other Study ID Numbers: 41327
First Posted: September 17, 2019    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases