Status:
COMPLETED
Efficacy of a New Nanoemulsion Artificial Tear Targeting Dry Eye Disease
Lead Sponsor:
The Hong Kong Polytechnic University
Collaborating Sponsors:
Alcon Research
Conditions:
Dry Eye Syndromes
Eligibility:
All Genders
20-50 years
Phase:
PHASE2
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 d...
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 si...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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.
Key Trial Info
Start Date :
January 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 4 2024
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT06188260
Start Date
January 16 2024
End Date
November 4 2024
Last Update
December 2 2024
Active Locations (1)
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1
Thomas LAM
Hong Kong, Hong Kong, Hong Kong, 999077