Efficacy of a New Nanoemulsion Artificial Tear Targeting Dry Eye Disease

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

This is a prospective cohort study to compare subjective changes in symptoms using the Ocular Surface Disease Index (OSDI) questionnaire, following the recommended dosage of the new nanoemulsion eye drops (Systane Complete)in mild to moderate dry eye patients, and to investigate objective ocular surface changes using modern clinical instruments during the study period.

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndromes
• Intervention / Treatment: Drug: Systane COMPLETE Lubricant Eye Drops

Detailed Description

This study, lasting for 3 months in total, is to investigate the changes in both subjective reports (OSDI score) and objective measurements (Non-invasive Tear Break Time (NITBUT) and other clinical signs such as corneal staining) after the use of this nanoemulsion eye drops (Systane Complete). Subjects are required to use the eyedrop qid for 3 months, and come back for follow-up at 2-week and 3-month visits. Other secondary measurements such as Meibography and lipid layer thickness, will also be investigated.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 2

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong, 999077
    • Thomas LAM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 20-50 years old
2. Best corrected distance visual acuity ≥ 6/9
3. Mild to moderate OSDI score 13-32
4. Any one of the objective test positive (NITBUT/Corneal fluorescein staining/Tear osmolarity)

Exclusion Criteria:

1. Any active ocular infections
2. Inflammations or anomalies in the eyelid
3. Uncontrolled, newly diagnosed systemic diseases or with modified long-term medications within 6 months that are known to affect tear profile.
4. Pregnancy and breastfeeding
5. Contact lens wearers are required to stop contact lenses wear for at least 1 week before the evaluation.
6. Subjects who are using artificial tears or other eyedrops will be excluded.
7. Subjects who are taking systemic drugs that may cause dry eye, e.g., Antidepressants/antipsychotics, Systemic corticosteroids.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dry eye participants; 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	Drug: Systane COMPLETE Lubricant Eye Drops; Active Ingredients: Propylene Glycol 0.6% Purpose: Lubricant; Other Names: Alcon limited

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular Surface Disease Index (OSDI)	Change in OSDI score at 2-week visit	Change in OSDI score at 2-week visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non invasive tear break-up time (NITBUT)	NITBUT at 2-week and 3-month visits	NITBUT at 2-week and 3-month visits
Meibography	Meibography at 2-week and 3-month visits	Meibography at 2-week and 3-month visits

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Collaborators: Alcon Research
• Investigators: Principal Investigator: Thomas LAM, PhD, The Hong Kong Polytechnique University

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2024
• Primary Completion (Actual): November 4, 2024
• Study Completion (Actual): November 4, 2024

Study Registration Dates

• First Submitted: December 18, 2023
• First Submitted That Met QC Criteria: December 18, 2023
• First Posted (Actual): January 3, 2024

Study Record Updates

• Last Update Posted (Estimated): December 2, 2024
• Last Update Submitted That Met QC Criteria: November 27, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Corneal Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Pharmaceutical Solutions; Lubricant Eye Drops; Ophthalmic Solutions
• Other Study ID Numbers: 20230209004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No