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

Phase 2

Completed

• Conditions: Dry Eye
• Interventions: Drug: 0.38% Sodium Hyaluronate (SH) Eye Drops; Drug: 0.18% Sodium Hyaluronate Eye Drops; Drug: Normal Saline Eye Drops

• Registration Number: NCT06851364
• Lead Sponsor: International Islamic University Malaysia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-30
• Primary Completion: 2023-02-03
• Study Completion: 2023-02-03
• Status Verified: 2023-11
• Study First Submitted: 2025-02-24
• Study First Submitted QC: 2025-02-24
• Last Update Submitted: 2025-02-27
• Study First Posted: 2025-02-28
• Last Update Posted: 2025-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.38% Sodium Hyaluronate (SH) Eye Drops	0.38% Sodium Hyaluronate (SH) Eye Drops	-
0.18% Sodium Hyaluronate (SH) Eye Drops	0.18% Sodium Hyaluronate Eye Drops	-
Normal Saline Eye Drops	Normal Saline Eye Drops	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Islamic University of Gaza (IUG); 🇵🇸 Gaza, Palestinian Territory, occupied