Clinical trial NCT06851364: Efficacy of 0.38% and 0.18% Sodium Hyaluronate Ocular Lubricants for Dry Eye in Adult Gazan Participants
Official title: Efficacy of 0.38% and 0.18% Sodium Hyaluronate Ocular Lubricants for Dry Eye: A Randomized Trial in Adult Gazan Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye
Keywords: Evaporative Dry Eye (EDE)
Ocular Surface Disease
Tear Film Dysfunction
Ocular Lubricants
Lead sponsor: International Islamic University Malaysia
Sponsor class: OTHER
Collaborators: name: Islamic University of Gaza, Gaza, Palestine
First posted: 2025-02-28
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this completed clinical trial was to determine if 0.38% and 0.18% sodium hyaluronate (SH) lubricant eye drops improve symptoms of moderate to severe dry eye disease (DED) in adult Gazan participants. The main questions it aimed to answer were:

1. Did 0.38% and 0.18% SH eye drops improve Arab-Ocular Surface Disease Index (Arab-OSDI) scores?
2. Did these eye drops improve tear break-up time (TBUT), corneal fluorescein staining (CFS), and lissamine green conjunctival staining (LGS)?
3. Did 0.38% SH provide greater benefits in evaporative dry eye (EDE) compared to 0.18% SH and normal saline?
4. Researchers compared 0.38% SH, 0.18% SH, and normal saline eye drops to evaluate their effectiveness in symptom relief and clinical improvements.

Participants:

1. Applied their assigned eye drops three times daily for six weeks Used normal saline eye drops for the first week before starting their assigned treatment
2. Underwent clinical assessments at weeks 1, 3, and 6, including Arab-OSDI scoring, TBUT, CFS, and LGS tests
3. The study began on October 30, 2022, and was completed on February 3, 2023, with 45 participants each completing a 6-week trial period.


Eligibility criteria: Inclusion Criteria:

* Participants aged 18 to 40 years.
* Residents of South Gaza Strip.
* Diagnosed with moderate to severe dry eye disease (DED) based on Arab-OSDI score (≥ 23).

Exclusion Criteria:

* History of systemic diseases (e.g., rheumatoid arthritis, Sjögren syndrome, thyroid disorders).
* Previous punctal plugs or punctal cautery treatment for ocular surface pathologies.
* Presence of pterygium, evident lid/orbital disease with lagophthalmos, or history of punctal cautery.
* Contact lens (CL) users who always need to wear CLs.
* History of ocular surgeries within 6 months or LASIK within 12 months.
* Use of medications that could affect study results (e.g., antihistamines, antidepressants, aspirin, anticholinergics, corticosteroids) or recent use of central nervous system or hormonal medications within 30 days.
* Current use of ocular medications or those planning to start new medications during the study.
* Pregnant participants or those with ocular pathologies beyond DED and refractive errors.

Primary outcomes:
measure: Change in Arab-OSDI Score from baseline (Visit 2) to week 6 (Visit 5)
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gaza
country: Palestinian Territory, occupied
facility: Islamic University of Gaza (IUG)
Study officials:
References: