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.

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.

The study investigators may share individual participant data (IPD) upon reasonable request, in compliance with ethical and legal requirements. Data will be shared in a de-identified format to protect participant privacy. Access to the data will require approval from the research team and may be granted for purposes of meta-analyses or further research related to dry eye disease.

IPD and supporting documents (Study Protocol, Statistical Analysis Plan, Informed Consent Form) will be available starting 6 months after publication of primary results. The data will remain accessible for 5 years from the release date or upon reasonable request from qualified researchers.

Qualified researchers affiliated with academic institutions, research organizations, or healthcare entities may request access to the Individual Participant Data (IPD) and supporting documents (Study Protocol, Statistical Analysis Plan, Informed Consent Form). Access will be granted upon submission of a research proposal outlining the intended use of the data, along with institutional ethics approval or data-use agreements, if applicable. Requests will be reviewed by the study's data-sharing committee, and approved researchers will be provided access via a secure data-sharing platform. Data will be shared in a de-identified format to protect participant confidentiality, in compliance with ethical and regulatory guidelines.