The effect of Systane Complete versus saline on tear film properties in a symptomatic dry eye populatio

Phase 4

Completed

• Conditions: Dry eyes; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12619000275167
• Lead Sponsor: SW Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-25
• Study Completion: 2020-09-01
• Last Update Posted: 1 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent;
Adults aged 18 years and over with symptoms of dry eye;
Ocular Surface Disease Index score of greater than 12 at Screening (Visit 1);
Average lipid layer thickness less than or equal to 75nm in at least one eye at Screening;
Not wearing contact lenses for 1 month prior to the study and for the duration of the study;
Willing to use the study eye drops and refrain from using any other eye drops for the duration of the study;
Willing to refrain from using the study eye drops within 4 hours prior to each study visit;
Willing to comply with the study visit schedule and adhere to instructions as directed by the Investigator.

Exclusion Criteria

Any active anterior segment disease excluding blepharitis;
Use of any of the following medications (including steroids) up to 12 weeks prior to start of the study or during the course of the study:
Ocular medication, category S3 and above;
Any systemic or topical medications that will affect ocular physiology e.g. anti-acne medications such as Roaccutane and corticosteroid or immunosuppressant medications such as Hydrocortisone, Prednisolone and antihistamine medications such as Claritine.
Use of any polyunsaturated fatty acid-containing dietary supplements (such as fish oil, evening primrose oil, linseed oil) for less than 12 weeks prior to the start of the study;
Planned changes to intake of polyunsaturated fatty acid-containing dietary supplements and/or diet (including typical intake of fish) for the duration of the study;
Use of any at-home eyelid warming treatments for less than 12 weeks prior to the start of the study, or planned changes to routine usage over the course of the study;
Use of any of the following dry eye treatments up to 6 months prior to the start of the study or during the course of the study:
oIntense Pulsed Light (IPL) therapy;
oBlephasteam;
oLipiFlow Thermal Pulsation treatment;
oPunctal plugs.
Any systemic disease that may affect ocular health e.g. Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis and systemic lupus erythematosus;
History of eye surgery within 6 months prior to enrolment in the study;
Epilepsy or history of migraines exacerbated by flashing, strobe-like lights;
Any known allergy to the ingredients in Systane Complete;
Pregnancy or breastfeeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
on-invasive tear break-up time, measured in seconds using the Oculus Keratograph 5M[1 hour and 2 hours post-eye drop instillation after first use on day 1, and once after 4 weeks of daily use.<br>The primary endpoint is unknown and subject to investigation. However, appropriate statistical adjustments will be applied during the analysis to account for multiple comparisons.]

Secondary Outcome Measures

Name	Time	Method
ipid layer thickness is measured in nanometres using the LipiView II Ocular Surface Interferometer[1 hour and 2 hours post-eye drop instillation after first use on day 1, and once after 4 weeks of daily use];Tear osmolarity is measured using the TearLab[1 hour and 2 hours post-eye drop instillation after first use on day 1, and once after 4 weeks of daily use];Tear evaporation rate is measured using a modified Vapometer[1 hour and 2 hours post-eye drop instillation after first use on day 1, and once after 4 weeks of daily use]