Safety and Efficacy of Kelulut Honey Eyedrops in Dry Eye Disease

NCT07279324 | Not Yet Recruiting

• 1 other identifier: USM-KHED-2025-01
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does Kelulut honey improve tear film stability and dry eye symptoms?
2. 2.Are Kelulut honey eyedrops safe and well tolerated on the ocular surface?
3. 3.Use Kelulut honey eyedrops (12.5%, 25%, or 50%) three times daily for 1 month, in addition to continuing their usual dry eye treatments.
4. 4.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).
5. 5.Report any changes in symptoms or any discomfort, including stinging, redness, irritation, or other adverse effects experienced during the study.

Conditions

Dry Eye Disease (DED); Dry Eye Syndrome (DES); Dry Eye Symptoms

Outcome Measures

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

  Baseline, Week 2 and Week 4

Secondary Outcomes (3)

• Changes in Tear Break-Up Time (TBUT)

  Baseline, Week 2 and Week 4.

• Changes in Ocular Surface Disease Index (OSDI) score

  Baseline, Week 2 and Week 4.

• Schirmer I Test Value

  Baseline, Week 2 and Week 4

Other Outcomes (2)

• Conjunctival Hyperaemia Score

  Baseline, Week 2 and Week 4.

• Subjective Ratings of Comfort

  Baseline, Week 2 and Week 4.

Study Arms (3)

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.

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.

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.

Drug: Kelulut Honey Eyedrop 50%

Interventions

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.

KHED 12.5%

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.

KHED 25%

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

KHED 50%

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

Hospital Pakar Universiti Sains Malaysia

Kota Bharu, Kelantan, 16150, Malaysia

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Central Study Contacts

Shahidatul Adha Mohamad Dr, MD, MMed

CONTACT

+609-767 6362; shieda@usm.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: 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.

Study Record Dates

• First Submitted: November 30, 2025
• First Posted: December 12, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: December 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)