Safety and Efficacy of Kelulut Honey Eyedrops in Dry Eye Disease (NCT07279324) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Safety and Efficacy of Kelulut Honey Eyedrops in Dry Eye Disease
Malaysia45 participantsStarted 2026-04-01
Plain-language summary
The goal of this clinical trial is to learn whether Kelulut honey eyedrops are safe and helpful in treating dry eye disease in adults. It will also learn about any side effects that may occur with the use of Kelulut honey eyedrops.
This Kelulut honey eyedrops are sterile ophthalmic solutions formulated with honey derived from stingless bees (Trigona spp.) at concentrations of 12.5% 25% and 50%. The eyedrop formulations are prepared according to a standardized laboratory protocol to ensure sterility, stability, and suitability for ocular use. Full formulation details are proprietary but can be provided to the ethics committee or regulatory authorities upon request.
The main questions this clinical trial aims to answer are:
1. Does Kelulut honey improve tear film stability and dry eye symptoms?
2. Are Kelulut honey eyedrops safe and well tolerated on the ocular surface?
Researchers will compare different concentrations of Kelulut honey eyedrops to determine which concentration provides the best balance of safety and clinical benefit.
Participants will:
1. Use Kelulut honey eyedrops (12.5%, 25%, or 50%) three times daily for 1 month, in addition to continuing their usual dry eye treatments.
2. Attend scheduled follow-up visits (on week 2 and week 4) for eye examinations and dry eye assessments (e.g., TBUT, ocular surface staining, Schirmer test, and OSDI).
3. Report any changes in symptoms or any discomfort, including stinging, redness, irritation, or other adverse effects experienced during the study.
Who can participate
Age range
18 Years – 50 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 18-50 years at the time of consent.
. Clinical diagnosis of dry eye disease in at least one eye, based on symptoms and clinical signs (Symptomatic dry eye, defined as an OSDI score ≥ 13; objective evidence of tear film instability, such as TBUT \< 10 seconds in at least one eye)
. Participants may be Treatment-naïve, OR on stable dry eye treatment for at least 2 weeks before enrollment.
. Willing to use Kelulut honey eyedrops three times daily for 1 month as instructed.
. Able and willing to attend all study visits (Baseline, Week 2, Week 4).
Exclusion criteria
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 using Kelulut honey as an eye drop for dry eye disease — is there anything known about honey-based eye drops in general that would help me understand whether this approach might be worth considering for my specific situation?
2The trial hasn't started recruiting yet — given that timeline uncertainty, should I be looking at other treatments or trials that are already enrolling while I wait to see if this one opens up?
3The main thing this trial is measuring is how much corneal fluorescein staining improves, which reflects surface damage to the eye — how severe is my corneal staining right now, and would that make me a good or poor candidate to watch this trial's results?
4This trial is listed as Phase NA, which means it may be a very early or exploratory study — what does that tell us about how much safety and effectiveness data already exists for Kelulut honey eye drops, and what unknowns should I be aware of?
5Are there standard dry eye treatments I haven't tried yet that might be a better first step before considering an experimental honey-based eye drop like the one in this trial?
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.