Dry Eye Disease (DED)
Conditions
Brief summary
Dry Eye Disease (DED) is a common, chronic ocular surface disorder characterized by tear film instability, ocular discomfort, and visual disturbance. Artificial tears are the first-line treatment for DED; however, many formulations contain preservatives such as benzalkonium chloride (BAK) and stabilized oxychloro complex (SOC) which may cause ocular surface toxicity with long-term use. Preservative-free artificial tears are considered safer alternatives, but comparative clinical evidence from Nepal is limited. This study aims to compare the clinical efficacy and safety of preservative-free versus preserved carboxymethylcellulose (CMC) artificial tears in patients with Dry Eye Disease. This will be a hospital-based, randomized, double-blinded controlled clinical trial conducted in the ophthalmology outpatient department of a tertiary care hospital in Nepal. A total of 80 adult patients diagnosed with Dry Eye Disease will be enrolled and randomly allocated in a 1:1 ratio to receive either preservative-free CMC artificial tears or preserved CMC artificial tears for a duration of eight weeks. Participant, investigators, outcome assessors and data analysts will remain blinded to minimize assessment bias. Baseline assessments will include the Ocular Surface Disease Index (OSDI) questionnaire, Tear Film Break-Up Time (TBUT), Schirmer's test (without anesthesia), and corneal fluorescein staining. These outcomes will be reassessed at four and eight weeks. Safety and tolerability will be evaluated by documenting patient-reported adverse effects. Data will be analyzed using appropriate statistical methods, with a p-value of less than 0.05 considered statistically significant. The study is expected to demonstrate superior safety and improved ocular surface outcomes with preservative-free artificial tears compared to preserved formulations. Findings from this research will provide local evidence to guide rational prescribing practices and improve the management of Dry Eye Disease in Nepal.
Interventions
A total of 40 adult patients diagnosed with Dry Eye Disease will be enrolled and randomly allocated in a 1:1 ratio to receive preserved CMC artificial tears for a duration of eight weeks.
DRUGPreservative free Carboxy methyl cellulose
A total of 40 adult patients diagnosed with Dry Eye Disease will be enrolled and randomly allocated in a 1:1 ratio to receive preservative-free CMC artificial tears for a duration of eight weeks.
Sponsors
Pokhara Academy of Health Sciences, Western Regional Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * Clinical diagnosis of Dry Eye Disease (OSDI \>13 and TBUT \<10 seconds) * Willingness to provide written informed consent
Exclusion criteria
* Contact lens use * Active ocular infection or inflammation * History of ocular surgery within the past 6 months * Use of systemic immunosuppressive therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Surface Disease Index (OSDI) Score | From enrollment to the end of treatment at 8 weeks | Ocular Surface Disease Index (OSDI) Score. The OSDI is a 12-item questionnaire that assesses dry eye symptoms and their impact on vision-related functioning. Total scores range from a minimum of 0 to a maximum of 100. Higher scores indicate more severe dry eye symptoms and a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tear Film Break-Up Time (TBUT) | From enrollment to the end of treatment at 8 weeks | Tear Film Break-Up Time (TBUT). This measures the time elapsed in seconds between a complete blink and the appearance of the first dry spot on the cornea. It does not have a strict maximum value, but a minimum of 0 seconds. Higher values indicate a more stable tear film and a better outcome. |
| Schirmer's Test (without anesthesia) | From enrollment to the end of treatment at 8 weeks | This measures basic tear production by placing a paper strip inside the lower eyelid for 5 minutes. It is measured in millimeters (mm) of wetting, with a minimum of 0 mm and a typical maximum of 35 mm. Higher values indicate better tear production and a better outcome. |
| Corneal Fluorescein Staining Score | From enrollment to the end of treatment at 8 weeks | Corneal Fluorescein Staining Score using the Oxford Grading Scheme. This scale assesses the severity of damage to the surface of the eye. The total score ranges from a minimum of 0 to a maximum of 15. Higher scores indicate greater damage to the cornea and a worse outcome. |
Countries
Nepal
Contacts
CONTACTDamodar Sharma, MBBS, MD
CONTACTJamuna Gurung, MBBS, MD
Outcome results
None listed