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Completed

NCT Number: NCT06851364

Efficacy of 0.38% and 0.18% Sodium Hyaluronate Ocular Lubricants for Dry Eye in Adult Gazan Participants

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.

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Islamic University of Gaza (IUG)

Gaza, PO Box 108, Palestinian Territories

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

0.38% Sodium Hyaluronate (SH) Eye Drops

Drug

A lubricant eye drop containing 0.38% sodium hyaluronate (SH), designed to improve tear film stability and ocular surface health in individuals with moderate to severe dry eye disease (DED).

The formulation has a higher viscosity and retention time, potentially offering better symptom relief for evaporative dry eye (EDE).

0.18% Sodium Hyaluronate Eye Drops

Drug

A lubricant eye drop containing 0.18% sodium hyaluronate (SH), used to alleviate dry eye symptoms and improve tear film stability.

This formulation has a lower viscosity compared to 0.38% SH, potentially providing faster absorption but with shorter ocular surface retention.

Normal Saline Eye Drops

Drug

A non-active control treatment consisting of sterile normal saline (0.9% NaCl) used as a placebo comparator.

It provides temporary moisture but lacks the viscoelastic and therapeutic properties of sodium hyaluronate.

Primary outcomes

  1. Change in Arab-OSDI Score from baseline (Visit 2) to week 6 (Visit 5)

    Time frame: 6 weeks

    The primary outcome is the improvement in dry eye symptoms, as measured by the Arabic version of the Ocular Surface Disease Index (Arab-OSDI) questionnaire. A reduction in the Arab-OSDI score indicates symptom improvement.

Sponsors and collaborators

Lead sponsor

International Islamic University Malaysia

Other

Collaborators

  • Islamic University of Gaza, Gaza, Palestine

Registry information

Official study title

Efficacy of 0.38% and 0.18% Sodium Hyaluronate Ocular Lubricants for Dry Eye: A Randomized Trial in Adult Gazan Participants

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 28, 2025
Registry last updated
Mar 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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