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

NCT ID: NCT06851364

Last Updated: 2025-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-30
• Study Completion Date: 2023-02-03

Brief 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. 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.

Conditions

Dry Eye

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

0.38% Sodium Hyaluronate (SH) Eye Drops

Group Type: EXPERIMENTAL

0.38% Sodium Hyaluronate (SH) Eye Drops

Intervention Type: 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 (SH) Eye Drops

Group Type: EXPERIMENTAL

0.18% Sodium Hyaluronate Eye Drops

Intervention Type: 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

Group Type: PLACEBO_COMPARATOR

Normal Saline Eye Drops

Intervention Type: 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.

Interventions

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).

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Islamic University of Gaza, Gaza, Palestine

UNKNOWN

Sponsor Role: collaborator

International Islamic University Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Mohd Zulfaezal Che Azemin

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Islamic University of Gaza (IUG)

Gaza, , Palestinian Territories

Countries

Palestinian Territories

Other Identifiers

PHRC/HC/883/21

Identifier Type: -

Identifier Source: org_study_id