Dry Eye Disease (DED)NCT07279324
Safety and Efficacy of Kelulut Honey Eyedrops in Dry Eye Disease
A study testing Kelulut Honey Eyedrop 12.5%, Kelulut Honey Eyedrop 25% and Kelulut Honey Eyedrop 50% in people with Dry Eye Disease (DED) and Dry Eye Syndrome (DES), run by Universiti Sains Malaysia at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Dry Eye Disease (DED), Dry Eye Syndrome (DES), Dry Eye Symptoms
- What is being tested?
- Kelulut Honey Eyedrop 12.5%, Kelulut Honey Eyedrop 25% and Kelulut Honey Eyedrop 50%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Apr 2026to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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
- Ocular surgery or laser procedures within the past 6 months.
- Use of topical ocular medications other than lubricants within the past 30 days
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- Contact lens wear within 1 week prior to baseline or expected during the study.
- Punctal plugs or other lacrimal procedures within the last 3 months.
- Systemic diseases that significantly affect the ocular surface and are unstable or uncontrolled (e.g., uncontrolled Sjögren's, uncontrolled rheumatoid arthritis, uncontrolled diabetes).
- Participation in another clinical trial or receipt of an investigational product within the past 30 days.
- Pregnant or breastfeeding women, or those planning pregnancy during the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site
Hospital Pakar Universiti Sains Malaysia
Kota Bharu, Kelantan, 16150
About this study
Official title: Pilot Study on the Safety and Efficacy of Kelulut Honey Eyedrops for 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.
Read more
The main questions this clinical trial aims to answer are:
- Does Kelulut honey improve tear film stability and dry eye symptoms?
- 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:
- Use Kelulut honey eyedrops (12.5%, 25%, or 50%) three times daily for 1 month, in addition to continuing their usual dry eye treatments.
- 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).
- Report any changes in symptoms or any discomfort, including stinging, redness, irritation, or other adverse effects experienced during the study.
- Being tested
- Kelulut Honey Eyedrop 12.5%, Kelulut Honey Eyedrop 25%, Kelulut Honey Eyedrop 50%
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kelulut Honey Eyedrop 12.5%Drug
KHED 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%Drug
KHED 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%Drug
KHED 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
| Study group | Role | What they receive |
|---|---|---|
| KHED 12.5% | Experimental | Participants in this arm will use Kelulut honey eyedrops formulated with Kelulut honey derived from stingless bees (Trigona spp.) at a concentration of 12.5%. The eyedrops will be administered three times daily for 1 month, in addition to the participant's usual dry eye treatments. Safety, tolerability, and changes in tear film parameters will be assessed. Receives: Drug: Kelulut Honey Eyedrop 12.5% |
| KHED 25% | Experimental | Participants in this arm will use Kelulut honey eyedrops formulated with Kelulut honey derived from stingless bees (Trigona spp.) at a concentration of 25%. The eyedrops will be administered three times daily for 1 month, in addition to the participant's usual dry eye treatments. Safety, tolerability, and changes in tear film parameters will be assessed. Receives: Drug: Kelulut Honey Eyedrop 25% |
| KHED 50% | Experimental | Participants in this arm will use Kelulut honey eyedrops formulated with Kelulut honey derived from stingless bees (Trigona spp.) at a concentration of 50%. The eyedrops will be administered three times daily for 1 month, in addition to the participant's usual dry eye treatments. Safety, tolerability, and changes in tear film parameters will be assessed. Receives: Drug: Kelulut Honey Eyedrop 50% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- = 1-5 punctate dots
- = 6-30 punctate dots
- = >30 dots or coalescent staining
Measured: Baseline, Week 2 and Week 4
Secondary outcomes (3)
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.
Measured: Baseline, Week 2 and Week 4.
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.
Measured: Baseline, Week 2 and Week 4.
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.
Measured: Baseline, Week 2 and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start1 Apr 2026 (estimated)
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye Disease (DED)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, parallel, three-arm pilot study comparing the safety and preliminary efficacy of Kelulut honey eyedrops at three concentrations (12.5%, 25%, and 50%) over a 1-month treatment period.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahidatul Adha Mohamad, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07279324
- Sponsor's protocol ID
- USM-KHED-2025-01
- Status last verified
- Nov 2025
- First submitted
- 30 Nov 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Safety and Efficacy of Kelulut Honey Eyedrops for Dry Eye Disease
- ClinicalTrials.gov ID
- NCT07279324
- Acronym / sponsor ID
- USM-KHED-2025-01
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does Kelulut honey improve tear film stability and dry eye symptoms?
- 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:
- Use Kelulut honey eyedrops (12.5%, 25%, or 50%) three times daily for 1 month, in addition to continuing their usual dry eye treatments.
- 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).
- Report any changes in symptoms or any discomfort, including stinging, redness, irritation, or other adverse effects experienced during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A randomized, parallel, three-arm pilot study comparing the safety and preliminary efficacy of Kelulut honey eyedrops at three concentrations (12.5%, 25%, and 50%) over a 1-month treatment period.
| Arm | Type | Receives |
|---|---|---|
| KHED 12.5% | Experimental | Drug: Kelulut Honey Eyedrop 12.5%Participants in this arm will use Kelulut honey eyedrops formulated with Kelulut honey derived from stingless bees (Trigona spp.) at a concentration of 12.5%. The eyedrops will be administered three times daily for 1 month, in addition to the participant's usual dry eye treatments. Safety, tolerability, and changes in tear film parameters will be assessed. |
| KHED 25% | Experimental | Drug: Kelulut Honey Eyedrop 25%Participants in this arm will use Kelulut honey eyedrops formulated with Kelulut honey derived from stingless bees (Trigona spp.) at a concentration of 25%. The eyedrops will be administered three times daily for 1 month, in addition to the participant's usual dry eye treatments. Safety, tolerability, and changes in tear film parameters will be assessed. |
| KHED 50% | Experimental | Drug: Kelulut Honey Eyedrop 50%Participants in this arm will use Kelulut honey eyedrops formulated with Kelulut honey derived from stingless bees (Trigona spp.) at a concentration of 50%. The eyedrops will be administered three times daily for 1 month, in addition to the participant's usual dry eye treatments. Safety, tolerability, and changes in tear film parameters will be assessed. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (11 listed)
- 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
- Ocular surgery or laser procedures within the past 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kelulut Honey Eyedrop 12.5%KHED 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. | Drug | KHED 12.5% |
| Kelulut Honey Eyedrop 25%KHED 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. | Drug | KHED 25% |
| Kelulut Honey Eyedrop 50%KHED 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 | Drug | KHED 50% |
Primary outcome
Change in Corneal Fluorescein Staining Score
Time frame: Baseline, Week 2 and Week 4
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
3 secondary outcomes
Changes in Tear Break-Up Time (TBUT)
Time frame: Baseline, Week 2 and Week 4.
Changes in Ocular Surface Disease Index (OSDI) score
Time frame: Baseline, Week 2 and Week 4.
Schirmer I Test Value
Time frame: Baseline, Week 2 and Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kelulut Honey Eyedrop 12.5%, Kelulut Honey Eyedrop 25% and Kelulut Honey Eyedrop 50% in people with Dry Eye Disease (DED) and Dry Eye Syndrome (DES), run by Universiti Sains Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shahidatul Adha Mohamad Dr, MD, MMed (+609-767 6362, shieda@usm.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Corneal Fluorescein Staining Score (time frame: Baseline, Week 2 and Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.