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

Efficacy of 0.38% and 0.18% Sodium Hyaluronate Ocular Lubricants for Dry Eye: a Randomized Trial 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.

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Drug: 0.38% Sodium Hyaluronate (SH) Eye Drops; Drug: 0.18% Sodium Hyaluronate Eye Drops; Drug: Normal Saline Eye Drops

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 2

Contacts and Locations

Study Locations

• Palestinian Territory, occupied
  • Gaza, Palestinian Territory, occupied, PO Box 108
    • Islamic University of Gaza (IUG)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 0.38% Sodium Hyaluronate (SH) Eye Drops	Drug: 0.38% Sodium Hyaluronate (SH) Eye Drops; 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).
Experimental: 0.18% Sodium Hyaluronate (SH) Eye Drops	Drug: 0.18% Sodium Hyaluronate Eye Drops; 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.
Placebo Comparator: Normal Saline Eye Drops	Drug: Normal Saline Eye Drops; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Arab-OSDI Score from baseline (Visit 2) to week 6 (Visit 5)	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.	6 weeks

Collaborators and Investigators

• Sponsor: International Islamic University Malaysia
• Collaborators: Islamic University of Gaza, Gaza, Palestine

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2022
• Primary Completion (Actual): February 3, 2023
• Study Completion (Actual): February 3, 2023

Study Registration Dates

• First Submitted: February 24, 2025
• First Submitted That Met QC Criteria: February 24, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 27, 2025
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Ocular Surface Disease; Ocular Lubricants; Evaporative Dry Eye (EDE); Tear Film Dysfunction
• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Immunologic Factors; Physiological Effects of Drugs; Protective Agents; Adjuvants, Immunologic; Pharmaceutical Solutions; Viscosupplements; Hyaluronic Acid; Ophthalmic Solutions
• Other Study ID Numbers: PHRC/HC/883/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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 Sharing Time Frame: 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.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No