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

NCT04091581 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 41327
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Evaporative Dry Eye

Outcome Measures

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.

  Baseline (Prior to instillation); 10, 30 and 60 minutes post instillation of eye drop

Study Arms (2)

Non-Dry Eye

EXPERIMENTAL

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

Dry Eye

EXPERIMENTAL

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

Systane Complete DRUG

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

Dry Eye; Non-Dry Eye

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Waterloo: lead

Study Sites (1)

Centre for Ocular Research & Education

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Jill Woods
• Organization: Centre for Ocular Research and Education

jwoods@uwaterloo.ca

5198884567

Study Officials

• Lyndon Jones, PhD, FCOptom

  Centre for Ocular Research & Education

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: September 17, 2019
• Study Start: November 21, 2019
• Primary Completion: February 6, 2020
• Study Completion: February 6, 2020
• Last Updated: June 22, 2022
• Results First Posted: June 22, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)