Safety and Efficacy of Kelulut Honey Eyedrops in Dry Eye Disease

Официальное название

Pilot Study on the Safety and Efficacy of Kelulut Honey Eyedrops for Dry Eye Disease

Обзор

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.

Вмешательства

• Препарат 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.
• Препарат 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.
• Препарат 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

Первичные конечные точки

• Change in Corneal Fluorescein Staining Score [Срок оценки: Baseline, Week 2 and Week 4]

Вторичные конечные точки (3)

• Changes in Tear Break-Up Time (TBUT) [Срок оценки: Baseline, Week 2 and Week 4.]
• Changes in Ocular Surface Disease Index (OSDI) score [Срок оценки: Baseline, Week 2 and Week 4.]
• Schirmer I Test Value [Срок оценки: Baseline, Week 2 and Week 4]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Малайзия · 1 центр

• Hospital Pakar Universiti Sains Malaysia — Kota Bharu

Идентификаторы

NCT: NCT07279324 · USM-KHED-2025-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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