Status:
COMPLETED
Efficacy and Safety of Different Hyaluronic Acid Tear Substitutes Formulations in Evaporative Dry Eye
Lead Sponsor:
University of Seville
Conditions:
Dry Eye
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The objective of the study is to compare the efficacy and safety of different hyaluronic acid tear substitutes formulations in patients with evaporative dry eye. For this purpose, a randomized, single...
Eligibility Criteria
Inclusion
- Self-reported history DED.
- Ocular surface disease index (OSDI) \> 13 points.
- Non-invasive tear film break-up time (NIBUT) \< 10 s.
- Schirmer test (ST) without anesthesia ≥ 5 mm.
- MGD grade \> 1. For MGD, the Sirius device (CSO, Florence, Italy) was used, which determines MGD grade based on loss area of meibomian glands (LAMG). MGD grade was scored from 0 to 4 (MGD grade 1 = LAMG \< 25%; MGD grade 2 = LAMG ≥ 25% and \< 50%; MGD grade 3 = LAMG ≥ 50% and \< 75%; MGD grade 4 = LAMG ≥ 75%).
Exclusion
- Abnormal lid anatomy, including active blepharitis, and active lid margin.
- All corneal disorders that affect diagnostic test, such as active corneal infection and corneal dystrophies.
- Active ocular allergies.
- Vectored thermal pulsation (VTP) intense pulse light (IPL), quantum molecular resonance (QMR), or other procedure to treat DED within the previous 6 months.
- Intraocular surgery or laser ocular surgery within the previous 6 months.
- Use of topical antibiotics and anti-inflammatory treatments, including steroids and non-steroidal anti-inflammatory drugs.
- Systemic autoimmune diseases.
- Contact lens wearers.
- Pregnant or lactating women.
- Patients who did not understand or comprehend the informed consent.
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06517667
Start Date
November 1 2023
End Date
June 1 2024
Last Update
July 26 2024
Active Locations (1)
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1
Novovision ophthalmologic clinic
Murcia, Spain, 30009