Pilot Study on the Safety and Efficacy of Kelulut Honey Eyedrops for Dry Eye Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change in Corneal Fluorescein Staining Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
KHED 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.
干预措施: Kelulut Honey Eyedrop 12.5% (Drug)
KHED 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.
干预措施: Kelulut Honey Eyedrop 25% (Drug)
KHED 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.
干预措施: Kelulut Honey Eyedrop 50% (Drug)
结局指标
主要结局
Change in Corneal Fluorescein Staining Score
时间窗: 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
次要结局
- 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)
研究者
Shahidatul Adha Mohamad
Dr.
Universiti Sains Malaysia