Safety and Efficacy of Kelulut Honey Eyedrops in Dry Eye Disease

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.

NCT Number	NCT07279324
Lead Sponsor	Universiti Sains Malaysia
Conditions	Dry Eye Disease (DED), Dry Eye Syndrome (DES), Dry Eye Symptoms
Enrollment	45 participants
Start Date	2026-04-01
Primary Completion	2026-07-30 (estimated)
Study Completion	2026-10-30 (estimated)
Updated on ClinicalTrials.gov	2025-12-12