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

Evaporative Dry Eye Clinical Trial

— BULLDOG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04091581
• Other study ID #: 41327
• Status: Completed
• Phase: Phase 4
• Start date: November 21, 2019
• Est. completion date: February 6, 2020

Study information

• Verified date: June 2022
• Source: University of Waterloo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: February 6, 2020
• Est. primary completion date: February 6, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Evaporative Dry Eye
• Keratoconjunctivitis Sicca

Intervention

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

Locations

Country	Name	City	State
Canada	Centre for Ocular Research & Education	Waterloo	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Waterloo

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (Prior to instillation); 10, 30 and 60 minutes post instillation of eye drop