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

• Status: Recruiting
• Trial end date: 2024-11-13
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Hong Kong Polytechnic University
• Collaborator: Alcon Research
• Treatments: Lubricant Eye Drops; Ophthalmic Solutions

Criteria

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.