Dry Eye
Conditions
Keywords
Evaporative Dry Eye (EDE), Ocular Surface Disease, Tear Film Dysfunction, Ocular Lubricants
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.
Interventions
DRUG0.38% 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).
DRUG0.18% 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.
DRUGNormal 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.
Sponsors
Islamic University of Gaza, Gaza, Palestine
International Islamic University Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Palestinian Territories
Outcome results
None listed