Randomized Clinical Trial of Artificial Tears With and Without Preservatives in Patients With Dry Eye Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Carboxy methyl cellulose, Preservative free Carboxy methyl cellulose.
- Who it may be relevant to
- Registry conditions: Dry Eye Disease (DED). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Nepal
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparative Effectiveness of Artificial Tears With and Without Preservatives in Patients With Dry Eye Disease: A Randomized Clinical Trial
Overview
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
- Drug 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 preserved CMC artificial tears for a duration of eight weeks. - Drug Preservative 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.
Primary outcome measures
- Ocular Surface Disease Index (OSDI) Score [Time frame: From enrollment to the end of treatment at 8 weeks]
Secondary outcome measures (3)
- Tear Film Break-Up Time (TBUT) [Time frame: From enrollment to the end of treatment at 8 weeks]
- Schirmer's Test (without anesthesia) [Time frame: From enrollment to the end of treatment at 8 weeks]
- Corneal Fluorescein Staining Score [Time frame: From enrollment to the end of treatment at 8 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Supportive care
Study locations
Nepal · 1 center
- Pokhara Academy of Health Sciences — Pokhara
Identifiers
NCT: NCT07635849 · CTRL-DEDCMC-PRVFREE/WITHPRV