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.
Age ≥18 years
Clinical diagnosis of Dry Eye Disease (OSDI >13 and TBUT <10 seconds)
Willingness to provide written informed consent
Contact lens use
Active ocular infection or inflammation
History of ocular surgery within the past 6 months
Use of systemic immunosuppressive therapy
Parallel
Carboxy methyl cellulose
DrugA 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.
Preservative free Carboxy methyl cellulose
DrugA 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.
Ocular Surface Disease Index (OSDI) Score
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.
Tear Film Break-Up Time (TBUT)
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)
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
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.
Safety and Tolerability (Adverse Effects)
Patient-reported adverse effects will be systematically documented throughout the trial to evaluate the safety and tolerability of the respective artificial tear formulations
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