Efficacy of a New Nanoemulsion Artificial Tear Targeting Dry Eye Disease

NCT06188260 | Completed Phase 2

• 1 other identifier: 20230209004
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

• Ocular Surface Disease Index (OSDI)

  Change in OSDI score at 2-week visit

  Change in OSDI score at 2-week visit

Secondary Outcomes (2)

• Non invasive tear break-up time (NITBUT)

  NITBUT at 2-week and 3-month visits

• Meibography

  Meibography at 2-week and 3-month visits

Study Arms (1)

Dry eye participants

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

Drug: Systane COMPLETE Lubricant Eye Drops

Interventions

Systane COMPLETE Lubricant Eye Drops DRUG

Active Ingredients: Propylene Glycol 0.6% Purpose: Lubricant

Also known as: Alcon limited

Dry eye participants

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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
• Contact lens wearers are required to stop contact lenses wear for at least 1 week before the evaluation.
• Subjects who are using artificial tears or other eyedrops will be excluded.
• Subjects who are taking systemic drugs that may cause dry eye, e.g., Antidepressants/antipsychotics, Systemic corticosteroids.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Alcon Research: collaborator

Study Sites (1)

Thomas LAM

Hong Kong, Hong Kong, 999077, Hong Kong

Location

Related Publications (1)

• Liao X, Guo B, Bian J, Li PH, Tse JSH, Ngo W, Zhou L, Lam T. Efficacy of a new nanoemulsion artificial tear in dry eye disease management: Study protocol for a prospective cohort study. PLoS One. 2025 May 9;20(5):e0323523. doi: 10.1371/journal.pone.0323523. eCollection 2025.

  PMID: 40343954 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Thomas LAM, PhD

  The Hong Kong Polytechnique University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: January 3, 2024
• Study Start: January 16, 2024
• Primary Completion: November 4, 2024
• Study Completion: November 4, 2024
• Last Updated: December 2, 2024

Record last verified: 2023-12

Locations

HK (1)