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

Dry Eye Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06188260
• Other study ID #: 20230209004
• Status: Recruiting
• Phase: Phase 2
• Start date: November 13, 2023
• Est. completion date: November 13, 2024

Study information

• Verified date: January 2024
• Source: The Hong Kong Polytechnic University
• Contact: Thomas LAM, PhD
• Phone: 2766 6115
• Email: thomas.c.lam[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 13, 2024
• Est. primary completion date: June 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Systane COMPLETE Lubricant Eye Drops
Active Ingredients: Propylene Glycol 0.6% Purpose: Lubricant

Locations

Country	Name	City	State
Hong Kong	Thomas LAM	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	Alcon Research

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular Surface Disease Index (OSDI)	Change in OSDI score at 2-week visit	Change in OSDI score at 2-week visit
Secondary	Non invasive tear break-up time (NITBUT)	NITBUT at 2-week and 3-month visits	NITBUT at 2-week and 3-month visits
Secondary	Meibography	Meibography at 2-week and 3-month visits	Meibography at 2-week and 3-month visits