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

University of Waterloo

Status and phase: Completed; Phase 4

Conditions: Evaporative Dry Eye

Treatments: Drug: Systane Complete

Study type: Interventional

Funder types: Other

Identifiers

NCT04091581

41327

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

Non-Dry Eye

Experimental group

Description:

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

Treatment:

Drug: Systane Complete

Dry Eye

Experimental group

Description:

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

Treatment:

Drug: Systane Complete