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Evaluation of the safety and efficacy of Doxycycline in Chronic Meibomian Gland Dysfunction

Efficacy and Safety of Oral Doxycycline in Chronic Meibomian Gland Dysfunction: A Randomized Control Trial (The ODCMD trial) - The ODCMD trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/093711
Enrollment
344
Registered
2025-08-26
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H028- Other specified disorders of eyelid

Interventions

Intervention1: Doxycycline 20 mg + Standard of care (Lid scrub, lid message) + Tear substitute (CMC 4 times daily) + low-dose Doxycycline (20 mg twice daily) for 2 months.: Doxycycline 20 mg + Standar

Sponsors

Dr Phulen Sarma
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age 18?60 years. 2. Diagnosis of chronic MGD Based on clinical signs (meibomian gland expressibility, meibum quality, glandular atrophy) and symptoms (dry eye, grittiness, and irritation). 3.Symptom severity Moderate to severe MGD, as determined by the Ocular Surface Disease Index (OSDI) score and the Meibomian Gland Dysfunction Scale. 4.Willingness to comply Ability to comply with the study protocol, including the administration of oral medications and attending follow-up visits. 5.Informed consent Signed informed consent form, acknowledging the voluntary nature of participation and the potential risks involved.

Exclusion criteria

Exclusion criteria: 1.Presence of other ocular conditions: Active ocular infection, ocular surface disease (e.g., severe blepharitis, keratoconus), or any other significant eye disease that could confound study outcomes. 2.Severe systemic disease: Uncontrolled systemic conditions such as cardiovascular disease, liver disease, or autoimmune disorders that may interfere with the safe use of doxycycline. 3.Pregnancy or lactation: Women who are pregnant, planning to become pregnant, or breastfeeding during the study period. 4.Use of contraindicated medications: Current use of medications that interact with Doxycycline, such as anticoagulants, or use of other oral antibiotics for MGD in the past 30 days. 5.Allergy to Doxycycline: Known hypersensitivity or allergy to Doxycycline or other tetracycline-class antibiotics. 6.Recent ocular surgery or procedures: Any ocular surgery (e.g., cataract surgery) or eye procedure (e.g., punctal plugs) within the last 3 months. 7.Current use of topical steroids: Use of ocular steroids or other anti-inflammatory medications within 4 weeks prior to enrollments.

Design outcomes

Primary

MeasureTime frame
To compare the efficacy of high versus low dose of Doxycycline on Tear Film Breakup Time (TBUT).Timepoint: Baseline 8 weeks 5 months 8 months

Secondary

MeasureTime frame
1. To compare the safety of high versus low dose of Doxycycline among patients with Chronic Meibomian Gland Dysfunction. 2. To compare the efficacy of high versus low dose of Doxycycline on meibomian gland dysfunction score (MGD score). 3. To compare the efficacy of high versus low dose of Doxycycline on Ocular Surface Disease Index (OSDI) score. 4. To compare the efficacy of high versus low dose of Doxycycline on recurrence at 3 and 6 months after stopping of treatment 5. To compare the efficacy of high versus low dose of Doxycycline on Schirmer test readings. 6. To compare the efficacy of high versus low dose of Doxycycline Corneal staining score 7. To compare the efficacy of high versus low dose of Doxycycline on Tear fluid cytokine level (IL-1B). 8. To compare efficacy of high vs. low dose of Doxycycline on recurrence at 3 and 6 months after stopping of treatment.Timepoint: Baseline 8 weeks 5 months 8 months

Countries

India

Contacts

Public ContactDr Phulen Sarma

AIIMS, Guwahati

phulen10@gmail.com8728830834

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026