Safety and Efficacy of Kelulut Honey Eyedrops in Dry Eye Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUniversiti Sains Malaysia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Known allergy or hypersensitivity to honey, bee products, or any component of the study formulations.
Active ocular infection or inflammation (e.g., infectious conjunctivitis, keratitis, uveitis).
Severe allergic conjunctivitis or other ocular surface diseases
Significant meibomian gland dysfunction or blepharitis
Trial design
Design model
Parallel
Treatments tested in this trial
Kelulut Honey Eyedrop 12.5%
DrugKHED 12.5% is sterile ophthalmic solution containing Kelulut honey derived from stingless bees (Trigona spp.) at a concentration of 12.5%. Participants will instill one drop in each eye three times daily for 30 days, in addition to their usual dry eye treatments.
Kelulut Honey Eyedrop 25%
DrugKHED 25% is sterile ophthalmic solution containing Kelulut honey derived from stingless bees (Trigona spp.) at a concentration of 25%. Participants will instill one drop in each affected eye three times daily for 30 days, in addition to their usual dry eye treatments.
Kelulut Honey Eyedrop 50%
DrugKHED 50% is sterile ophthalmic solution containing Kelulut honey derived from stingless bees (Trigona spp.) at a concentration of 25%. Participants will instill one drop in each affected eye three times daily for 30 days, in addition to their usual dry eye treatments
Treatment groups
45 Participants
are divided into 3 treatment groupsGroup A: KHED 12.5%Experimental treatment 1 intervention
Group B: KHED 25%Experimental treatment 1 intervention
Group C: KHED 50%Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Corneal Fluorescein Staining Score
Corneal staining will be assessed using slit lamp biomicroscopy and graded using the National Eye Institute (NEI) scale. The cornea is divided into five zones (central, superior, inferior, nasal, temporal), each scored from 0 to 3 based on dot count: 0 = no staining 1. = 1-5 punctate dots 2. = 6-30 punctate dots 3. = \>30 dots or coalescent staining
Time frame
Baseline, Week 2 and Week 4Secondary outcomes
1
Changes in Tear Break-Up Time (TBUT)
TBUT will be measured after fluorescein instillation. The interval between the last blink and the first appearance of a dry spot on the cornea will be recorded. Three readings will be averaged. Longer TBUT indicates better tear film stability.
Time frame
Baseline, Week 2 and Week 4.2
Changes in Ocular Surface Disease Index (OSDI) score
The OSDI is a short 12-question survey that asks how often you experience dry eye symptoms and how much they affect your daily activities. Each question is scored from 0 ("none of the time") to 4 ("all of the time"). The total score ranges from 0 to 100, with higher scores meaning more severe dry eye symptoms.
Time frame
Baseline, Week 2 and Week 4.3
Schirmer I Test Value
Schirmer I test will be performed to measure aqueous tear production. A sterile strip will be placed in the lower eyelid, and the length of strip wetting in millimeters will be recorded after 5 minutes.
Time frame
Baseline, Week 2 and Week 4Other outcomes
1
Conjunctival Hyperaemia Score
Bulbar conjunctival hyperemia will be graded using a 0-3 scale (0 = none, 3 = severe).
Time frame
Baseline, Week 2 and Week 4.2
Subjective Ratings of Comfort
Participants will rate their eye comfort using a standardized scale from 0 to 10, where 0 means "unacceptable/very poor comfort" and 10 means "excellent comfort."
Time frame
Baseline, Week 2 and Week 4.Sponsors and contacts
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Source ClinicalTrials.gov
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