NCT06851364

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: International Islamic University Malaysia · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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).
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.
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.

Timeline

• Start date: 2022-10-30
• Primary completion: 2023-02-03
• Completion: 2023-02-03
• First posted: 2025-02-28
• Last updated: 2025-03-03

Locations

1 site across 1 country: Palestinian Territories