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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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