Not Yet RecruitingPhase 4

Randomized Clinical Trial of Artificial Tears With and Without Preservatives in Patients With Dry Eye Disease

Nepal80 participantsStarted 2026-07

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is comparing artificial tears with and without preservatives — based on my current dry eye symptoms and how often I'd need to use drops, which formulation does my doctor think is more appropriate for me, and would joining this trial help answer that question for my specific situation?
2Since this trial is Phase 4, meaning the drops being tested are already approved, what does my doctor think we already know about the safety of preserved versus preservative-free artificial tears, and is there anything meaningfully new I might learn by participating?
3The trial isn't recruiting yet — given that timeline, should I start or continue a current dry eye treatment now, and would doing so affect my eligibility if I later wanted to enroll?
4The main thing being measured is the OSDI score, which is a questionnaire about dry eye symptoms — would my doctor expect that score to capture everything important about how I'm feeling, or are there other aspects of my condition it might miss?
5Are there standard-of-care options my doctor would recommend I try first before considering a trial like this, and how would those compare to what's being tested here?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Ocular Surface Disease Index (OSDI) Score

Timeframe: From enrollment to the end of treatment at 8 weeks

Trial details

NCT IDNCT07635849

SponsorPokhara Academy of Health Sciences, Western Regional Hospital

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2027-01

Contact for this trial

Damodar Sharma, MBBS, MD

+977-9856022583 damodars@outlook.com

View on ClinicalTrials.gov More Dry Eye Disease (DED) trials