| CTRI Number |
CTRI/2025/08/093711 [Registered on: 26/08/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Other (Specify) [Drug therapy] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of the safety and efficacy of Doxycycline in Chronic Meibomian Gland Dysfunction |
|
Scientific Title of Study
|
Efficacy and Safety of Oral Doxycycline in Chronic Meibomian Gland Dysfunction: A Randomized Control Trial (The ODCMD trial) |
| Trial Acronym |
The ODCMD trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Phulen Sarma |
| Designation |
Assistant professor |
| Affiliation |
AIIMS, Guwahati |
| Address |
Department of Pharmacology, AIIMS, Guwahati Silbharal, Changsari, Guwahati – 781101 Kamrup ASSAM 781101 India |
| Phone |
8728830834 |
| Fax |
|
| Email |
phulen10@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Phulen Sarma |
| Designation |
Assistant professor |
| Affiliation |
AIIMS, Guwahati |
| Address |
Department of Pharmacology, AIIMS, Guwahati Silbharal, Changsari, Guwahati – 781101 Kamrup ASSAM 781101 India |
| Phone |
8728830834 |
| Fax |
|
| Email |
phulen10@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Phulen Sarma |
| Designation |
Assistant professor |
| Affiliation |
AIIMS, Guwahati |
| Address |
Department of Pharmacology, AIIMS, Guwahati Silbharal, Changsari, Guwahati – 781101 Kamrup ASSAM 781101 India |
| Phone |
8728830834 |
| Fax |
|
| Email |
phulen10@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Phulen Sarma (investigator initiated trial) |
|
|
Primary Sponsor
|
| Name |
Dr Phulen Sarma |
| Address |
Dr. Phulen Sarma, Pharmacology, AIIMS Guwahati |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Phulen Sarma |
AIIMS Guwahati |
Ophthalmology/Room 2072.
Pharmacology/Room of Dr. Phulen Sarma
Kamrup ASSAM |
8728830834
phulen10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Guwahati |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H028||Other specified disorders of eyelid, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Doxycycline 100 mg + Standard of care (Lid scrub, lid message) + Tear substitute (CMC 4 times daily) + high-dose Doxycycline (100 mg twice daily) for 2 months. |
Doxycycline 100 mg + Standard of care (Lid scrub, lid message) + Tear substitute (CMC 4 times daily) + high-dose Doxycycline (100 mg twice daily) for 2 months. |
| Intervention |
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 + Standard of care (Lid scrub, lid message) + Tear substitute (CMC 4 times daily) + low-dose Doxycycline (20 mg twice daily) for 2 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of high versus low dose of Doxycycline on Tear Film Breakup Time (TBUT). |
Baseline
8 weeks
5 months
8 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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. |
Baseline
8 weeks
5 months
8 months |
|
|
Target Sample Size
|
Total Sample Size="344" Sample Size from India="344"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Doxycycline is already being
used clinically and is in place in the management of chronic meibomian gland
dysfunction associated dry eye disease including the below mentioned
guidelines.
Indian Guideline: If chronic
symptoms and signs of MGD are not
adequately controlled by eyelid cleansing or meibomian gland expression, daily
oral doxycycline, minocycline, or tetracycline may be helpful and tapered when
clinical improvement is documented. [Guideline name: Evaporative dry eye
disease due to meibomian gland dysfunction: Preferred practice pattern
guidelines for diagnosis and treatment. Indian J Ophthalmol 2023;71:1348-56].
International workshop on
meibomian gland dysfunction: report of the subcommittee on management and
treatment of meibomian gland dysfunction:
Systemic tetracycline
derivatives (e.g., tetracycline 250 mg four times per day or doxycycline 100 mg
two times per day) for 6 weeks to several months in recurrent cases,
Recommendations in Clinical
Handbooks for Treatment of Posterior Blepharitis and Meibomitis:
Moorfields Manual: With
corneal involvement: Doxycycline 100 mg once a day or Erythromycin 250 mg four
times a day for 8 weeks.
Wills Eye Manual: Tetracycline
250 mg four times a day or doxycycline 100 mg twice a day for 6 weeks.
Japan: Oral administration of
azithromycin and tetracycline antimicrobials (doxycycline and minocycline) is
effective in improving subjective symptoms and meibomian gland
orifice/surrounding findings in patients with MGD.
This is to be noted that
patients are already getting Doxycycline 100 mg BD (the high dose mentioned in
our study) as per different guideline recommendations. However, single low
sample RCT has showed that efficacy is similar in both the cases (high dose and
low dose of doxycycline), however adverse effects were quite lower with the
lower dose compared to the traditionally used higher dose.
Given the potential side
effects associated with traditional higher doses of Doxycycline (100 mg BD),
such as gastrointestinal disturbances, this current study aims to fill the gap
by directly comparing low and high doses of Doxycycline, to evaluate their
relative efficacies and safety profiles in managing chronic MGD. |