Dry EyePhase 2NCT06851364
Efficacy of 0.38% and 0.18% Sodium Hyaluronate Ocular Lubricants for Dry Eye in Adult Gazan Participants
A Phase 2 study testing 0.38% Sodium Hyaluronate (SH) Eye Drops, 0.18% Sodium Hyaluronate Eye Drops and Normal Saline Eye Drops in people with Dry Eye, run by International Islamic University Malaysia at 1 site in Palestinian Territories.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Dry Eye
- What is being tested?
- 0.38% Sodium Hyaluronate (SH) Eye Drops, 0.18% Sodium Hyaluronate Eye Drops and Normal Saline Eye Drops
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- 30 Oct 2022to 3 Feb 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Palestinian Territories1 site
Islamic University of Gaza (IUG)
Gaza, PO Box 108
About this study
Official title: 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:
- Did 0.38% and 0.18% SH eye drops improve Arab-Ocular Surface Disease Index (Arab-OSDI) scores?
- Did these eye drops improve tear break-up time (TBUT), corneal fluorescein staining (CFS), and lissamine green conjunctival staining (LGS)?
- Did 0.38% SH provide greater benefits in evaporative dry eye (EDE) compared to 0.18% SH and normal saline?
- Researchers compared 0.38% SH, 0.18% SH, and normal saline eye drops to evaluate their effectiveness in symptom relief and clinical improvements.
Read more
Participants:
- 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
- Underwent clinical assessments at weeks 1, 3, and 6, including Arab-OSDI scoring, TBUT, CFS, and LGS tests
- The study began on October 30, 2022, and was completed on February 3, 2023, with 45 participants each completing a 6-week trial period.
- Conditions
- Dry Eye
- Being tested
- 0.38% Sodium Hyaluronate (SH) Eye Drops, 0.18% Sodium Hyaluronate Eye Drops, Normal Saline Eye Drops
- Keywords
- Evaporative Dry Eye (EDE), Ocular Surface Disease, Tear Film Dysfunction, Ocular Lubricants
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.38% Sodium Hyaluronate (SH) Eye DropsDrug
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 DropsDrug
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 DropsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 0.38% Sodium Hyaluronate (SH) Eye Drops | Experimental | Not described Receives: Drug: 0.38% Sodium Hyaluronate (SH) Eye Drops |
| 0.18% Sodium Hyaluronate (SH) Eye Drops | Experimental | Not described Receives: Drug: 0.18% Sodium Hyaluronate Eye Drops |
| Normal Saline Eye Drops | Placebo comparator | Not described Receives: Drug: Normal Saline Eye Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start30 Oct 2022
- Primary completion3 Feb 2023
- Study completion3 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Islamic University Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Islamic University of Caza, Gaza, Palestine
- Responsible party
- Principal investigator, Mohd Zulfaezal Che Azemin, International Islamic University Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06851364
- Sponsor's protocol ID
- PHRC/HC/883/21
- Status last verified
- Nov 2023
- First submitted
- 24 Feb 2025
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of 0.38% and 0.18% Sodium Hyaluronate Ocular Lubricants for Dry Eye: A Randomized Trial in Adult Gazan Participants
- ClinicalTrials.gov ID
- NCT06851364
- Acronym / sponsor ID
- PHRC/HC/883/21
- Conditions
- Dry Eye
- Keywords
- Evaporative Dry Eye (EDE), Ocular Surface Disease, Tear Film Dysfunction, Ocular Lubricants
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- International Islamic University MalaysiaUniversity, hospital or other
- Collaborators
- Islamic University of Caza, Gaza, Palestine
- Study start
- 30 Oct 2022 (actual)
- Primary completion
- 3 Feb 2023 (actual)
- Study completion
- 3 Feb 2023 (actual)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Did 0.38% and 0.18% SH eye drops improve Arab-Ocular Surface Disease Index (Arab-OSDI) scores?
- Did these eye drops improve tear break-up time (TBUT), corneal fluorescein staining (CFS), and lissamine green conjunctival staining (LGS)?
- Did 0.38% SH provide greater benefits in evaporative dry eye (EDE) compared to 0.18% SH and normal saline?
- Researchers compared 0.38% SH, 0.18% SH, and normal saline eye drops to evaluate their effectiveness in symptom relief and clinical improvements.
Participants:
- 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
- Underwent clinical assessments at weeks 1, 3, and 6, including Arab-OSDI scoring, TBUT, CFS, and LGS tests
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0.38% Sodium Hyaluronate (SH) Eye Drops | Experimental | Drug: 0.38% Sodium Hyaluronate (SH) Eye Drops |
| 0.18% Sodium Hyaluronate (SH) Eye Drops | Experimental | Drug: 0.18% Sodium Hyaluronate Eye Drops |
| Normal Saline Eye Drops | Placebo comparator | Drug: Normal Saline Eye Drops |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.38% Sodium Hyaluronate (SH) Eye DropsA 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). | Drug | 0.38% Sodium Hyaluronate (SH) Eye Drops |
| 0.18% Sodium Hyaluronate Eye DropsA 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. | Drug | 0.18% Sodium Hyaluronate (SH) Eye Drops |
| Normal Saline Eye DropsA 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. | Drug | Normal Saline Eye Drops |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 0.38% Sodium Hyaluronate (SH) Eye Drops, 0.18% Sodium Hyaluronate Eye Drops and Normal Saline Eye Drops in people with Dry Eye, run by International Islamic University Malaysia at 1 site in Palestinian Territories.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Palestinian Territories. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Arab-OSDI Score from baseline (Visit 2) to week 6 (Visit 5) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.