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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:
Researchers will compare different concentrations of Kelulut honey eyedrops to determine which concentration provides the best balance of safety and clinical benefit.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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
| Baseline, Week 2 and Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 2 and Week 4. |
| Measure | Description | Time Frame |
|---|---|---|
| Conjunctival Hyperaemia Score | Bulbar conjunctival hyperemia will be graded using a 0-3 scale (0 = none, 3 = severe). | Baseline, Week 2 and Week 4. |
| 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." |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shahidatul Adha Mohamad Dr, MD, MMed | Contact | +609-767 6362 | shieda@usm.my |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Pakar Universiti Sains Malaysia | Kota Bharu | Kelantan | 16150 | Malaysia |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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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.
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This study is masked to participants, care providers, investigators, and outcome assessors. The Kelulut honey eyedrops will be dispensed in identical sterile droppers labeled only with coded allocation numbers. The pharmacist preparing and dispensing the formulations is the sole unmasked individual. Investigators and assessors will remain blinded throughout the intervention period and until all data collection is complete. Unmasking will occur only after database lock, when the pharmacist releases the allocation code for analysis.
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| 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 |
|
| 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. |
| 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. | Baseline, Week 2 and Week 4 |
| Baseline, Week 2 and Week 4. |