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

February 27, 2025 updated by: Mohd Zulfaezal Che Azemin, International Islamic University Malaysia

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
International Islamic University Malaysia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Islamic University of Gaza, Gaza, Palestine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 30, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 3, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 3, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 24, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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