Completed

Efficacy of a New Nanoemulsion Artificial Tear in Dry Eye Disease Management

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What is being tested

Systane COMPLETE Lubricant Eye Drops

Drug
Who is being recruted

Eye Diseases

+ Lacrimal Apparatus Diseases

+ Dry Eye Syndromes

From 20 to 50 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: January 2024
See protocol details

Summary

Principal SponsorThe Hong Kong Polytechnic University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 16, 2024

Actual date on which the first participant was enrolled.

The study focuses on testing a new type of eye drop called nanoemulsion artificial tears, specifically Systane Complete, for people suffering from dry eye disease. The goal is to see how effective these eye drops are in improving both how patients feel and the actual health of their eyes. People with dry eye often struggle with discomfort and irritation, and this study aims to discover if this new treatment can offer better relief than existing options by improving symptoms and eye health indicators. Participants in the study will use the Systane Complete eye drops four times a day for three months. To track progress, they will attend follow-up appointments after two weeks and again after three months. Researchers will look at both how participants report their symptoms and objective measures, like how long the tear film lasts on the eye and the condition of the eye surface. Secondary evaluations, such as images of the meibomian glands and the thickness of the eye's lipid layer, will also be assessed. This approach helps determine the comprehensive impact of the treatment on dry eye symptoms and eye health.

Official TitleEfficacy of a New Nanoemulsion Artificial Tear in Dry Eye Disease Management
NCT06188260
Principal SponsorThe Hong Kong Polytechnic University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

31 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Eye DiseasesLacrimal Apparatus DiseasesDry Eye Syndromes

Criteria

4 inclusion criteria required to participate
Age 20-50 years old

Best corrected distance visual acuity ≥ 6/9

Mild to moderate OSDI score 13-32

Any one of the objective test positive (NITBUT/Corneal fluorescein staining/Tear osmolarity)

7 exclusion criteria prevent from participating
Any active ocular infections

Inflammations or anomalies in the eyelid

Uncontrolled, newly diagnosed systemic diseases or with modified long-term medications within 6 months that are known to affect tear profile.

Pregnancy and breastfeeding

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants aged 20 years or above, with OSDI score between 12-32, and with either of the following positive signs: 1) corneal staining; 2) NITBUT\<10s; 3) osmolarity \>=308, or difference \>8

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Thomas LAM

Hong Kong, Hong KongOpen Thomas LAM in Google Maps
CompletedOne Study Center