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.
Who can participate
Age range
18 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Arab-OSDI Score from baseline (Visit 2) to week 6 (Visit 5)