A Phase 4 interventional study of Carboxy methyl cellulose and Preservative free Carboxy methyl cellulose in Dry Eye Disease (DED), sponsored by Pokhara Academy of Health Sciences, Western Regional Hospital. Not yet recruiting at 1 site in Nepal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-10.
Sponsored by Pokhara Academy of Health Sciences, Western Regional Hospital · Phase 4, Interventional, and Supportive care
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.
1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.
This study's planned enrollment of 80 is above the median of 60 across 1,129 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →This is the only study on the registry with Pokhara Academy of Health Sciences, Western Regional Hospital as lead sponsor.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
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40 patients will receive drops in the eye
Drug: Carboxy methyl cellulose
40 patients will receive drops in the eye
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 preserved CMC artificial tears for a duration of eight weeks.
Also known as: preserved CMC
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.
Also known as: preservative-free CMC
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.
Time frame: From enrollment to the end of treatment at 8 weeks
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.
Time frame: From enrollment to the end of treatment at 8 weeks
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.
Time frame: From enrollment to the end of treatment at 8 weeks
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.
Time frame: From enrollment to the end of treatment at 8 weeks
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
Time frame: From enrollment to the end of treatment at 8 weeks
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jul 2026; primary completion for Jan 2027, 6 months later.
Of 84 non-industry phase 4 interventional studies under Dry Eye Syndromes, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 28. This study's planned 6 months is below that.
Counting every sponsor, half of 112 studies reached it within 12 months; a quarter within 5 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Carboxymethylcellulose