Kelulut honey as an add-on treatment for juvenile open-angle glaucoma

Supplementary Kelulut Honey Therapy in Juvenile Open-Angle Glaucoma: Effects on IL-6, RNFL and Dry Eye.

This trial will test whether taking 30 g of Kelulut (stingless bee) honey daily for three months helps lower inflammation, protect retinal nerve fibers, and improve dry eye in people aged 15–40 with juvenile open-angle glaucoma who are already on standard treatment.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 15 Years to 40 Years
• Sex: All
• Sponsor: Universiti Sains Malaysia (Academic / other)
• Locations: 4 sites (Kota Bharu, Kelantan and 3 other locations)
• Trial ID: NCT07396441 on ClinicalTrials.gov

What this trial studies

This is a randomized, multicenter, phase 4 trial in Malaysia enrolling 60 patients with juvenile open-angle glaucoma who have achieved target intraocular pressure on standard therapy. Participants are assigned by center to a honey group that consumes 30 g of Kelulut honey daily for 90 days or to a control group that receives usual care without honey. Outcomes before and after the intervention include serum interleukin-6 (IL-6), retinal nerve fiber layer (RNFL) thickness, tear break-up time (TBUT) and Schirmer Test 1, with compliance tracked by daily diaries and return of used sachets. Blood samples are processed centrally and ocular imaging and dry eye tests are performed using standardized protocols, with allergic reactions or adverse events leading to discontinuation as needed.

Who should consider this trial

Good fit: Ideal candidates are people aged 15–40 diagnosed with juvenile open-angle glaucoma who are compliant with conventional treatment, have achieved target intraocular pressure, and have no allergy to honey or major systemic comorbidities like diabetes or autoimmune disease.

Not a fit: Patients with diabetes, other retinal or optic nerve diseases, systemic neurodegenerative conditions, recent use of steroids or antioxidant/herbal products, or those who cannot comply with at least 75% adherence are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the supplement could reduce ocular or systemic inflammation, slow RNFL thinning, and improve dry eye symptoms as a low-risk adjunct to existing glaucoma care.

How similar studies have performed: There is limited clinical evidence for honey in glaucoma specifically; some small studies suggest anti-inflammatory or ocular-surface benefits from honey or related products, but this application is relatively novel and not yet well established.

Eligibility criteria

Inclusion Criteria:

JOAG patients age 15 years old and above until 40 years old at the time of diagnosis Compliant to conventional treatment achieved target intraocular pressure

Exclusion Criteria:

Patients with allergy to honey or honey-based products OCT signal less than 6/10 Concurrent retinal diseases and other optic neuropathies Systemic neurodegenerative disease Systemic comorbidities such as diabetes mellitus and autoimmune diseases Patients on other honey-based products for the last 3 months Patient who consumes honey-based products during the study duration of 3 months (monitoring via honey-diary, return of the used sachet during the follow up visits) Patients on anti-oxidants, traditional medications or herbal products for the last 3 months Topical usage of steroids, systemic steroids and non-steroidal anti-inflammatory drugs.

Sepsis Compliance less than 75%.

Where this trial is running

Kota Bharu, Kelantan and 3 other locations

• Hospital Raja Perempuan Zainab II — Kota Bharu, Kelantan, Malaysia (Recruiting)
• Hospital Sultan Ismail Petra — Kuala Krai, Kelantan, Malaysia (Recruiting)
• Hospital Universiti Sains Malaysia — Kubang Kerian, Kelantan, Malaysia (Recruiting)
• Hospital Sultanah Nur Zahirah — Kuala Terengganu, Terengganu, Malaysia (Recruiting)

Study contacts

• Study coordinator: Thamarai Munirathinam, MD(Prague)

Conditions Juvenile Open Angle Glaucoma; Dry Eye Disease; Interleukin 6; Retinal Nerve Fiber Layer Thickness; HbA1c Level