Efficacy and Safety of Topical Statin Eye Drop in the Management of Dry Eye Associated with Meibomian Gland Dysfunction (MGD)
Design
This double-blind, randomized clinical trial will include patients aged 40–65 with dry eye symptoms and TBUT < 10 seconds. After an initial safety phase on 10 volunteers, eligible patients will be consecutively enrolled and randomly assigned to receive either topical atorvastatin or placebo drops in one eye. Both groups will also undergo standard treatment with eyelid hygiene and warm compresses for 12 weeks. Outcomes including TBUT, Schirmer test, fluorescein staining, OSDI, DEQ5 scores, and meibomian gland expressibility will be evaluated at baseline and weeks 4, 8, and 12.
Settings and conduct
This randomized, double-blind clinical trial will be conducted at Shahid Labafi Nejad Hospital. A blinded ophthalmologist will perform all evaluations, and treatment codes will remain sealed until after the final data analysis.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Men and women aged 40–65 years who exhibit dry-eye symptoms and have a TBUT of < 10 seconds attributable exclusively to MGD. Exclusion criteria: Patients whose symptoms are caused by or occur alongside any other ocular disease
Intervention groups
Intervention group: Standard MGD treatment (eyelid hygiene) plus topical atorvastatin (50 µM), administered as one drop four times daily in one eye.
Control group: Standard MGD treatment (eyelid hygiene) plus placebo eye drops, administered as one drop four times daily in one eye.
Main outcome variables
OSDI Questionnaire score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250513065716N1
Registration date:2025-09-11, 1404/06/20
Registration timing:prospective
Last update:2025-09-11, 1404/06/20
Update count:0
Registration date
2025-09-11, 1404/06/20
Registrant information
Name
Salar Bahrami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 23601
Email address
salar.bahrami@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-09-23, 1404/07/01
Expected recruitment end date
2026-03-21, 1405/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy and safety of topical statin eye drop compared to placebo in the management of dry eye associated with meibomian gland dysfunction
Public title
Effect of Atorvastatin in treatment of MGD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being at the age of 40–65 years
Individuals exhibiting symptoms of dry eye and a tear break-up time (TBUT) of less than 10 seconds, attributable exclusively to Meibomian gland dysfunction
Exclusion criteria:
Oral statin administration
Use of doxycycline or other medications affecting MGD, such as azithromycin
Unwillingness to participate in the study
Hematologic or coagulation disorders; use of anticoagulant medications such as warfarin or Coumadin
History of peptic ulcer disease
Presence of concurrent ocular malignancies
History of ocular surgery within the past three months
History of ocular trauma
Age
From 40 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Type of Randomization: We used simple randomization with an individual unit of allocation.
Randomization Sequence Generation: The random allocation sequence was generated using a computer-generated random number table.
Allocation Concealment: Allocation concealment was ensured using sequentially numbered, opaque, sealed envelopes (SNOSE), which were prepared by an independent assistant not involved in the study.
Stratification: No stratified or block randomization was used in this study.
The randomization procedure was designed in consultation with an epidemiologist to ensure methodological rigor.
Blinding (investigator's opinion)
Double blinded
Blinding description
Neither participants nor the clinical evaluator will know whether the administered eye drop contains topical statin or placebo. both formulations have identical appearance, color, odor, viscosity, and packaging, and will be labeled with random allocation codes generated by a statistician who is otherwise uninvolved in the study. Assignment of each bottle to individual subjects will follow the permuted-block randomization list; only the pharmacist responsible for labeling and an independent data-safety officer will have access to the code key. All ocular examinations and outcome assessments will be performed by a single cornea specialist masked to group allocation. The randomization code will remain sealed until after completion of data collection and primary statistical analysis, except in the event of a serious adverse event that requires unblinding for patient safety.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
6th Floor, University Headquarters Building No. 2, Shahid Beheshti University of Medical Sciences and Health Services, E'arabi Street, Yemen Street, Shahid Chamran Expressway
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2023-10-08, 1402/07/16
Ethics committee reference number
IR.SBMU.ORC.REC.1402.018
Health conditions studied
1
Description of health condition studied
Meibomian Gland Dysfunction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Ocular surface disease index (OSDI) score
Timepoint
Measurement of the OSDI questionnaire score at baseline (prior to the intervention) and at weeks 4, 8, and 12 after initiation of the drug or placebo
Method of measurement
Ocular surface disease index is a questionnaire that assesses ocular symptoms, visual function, and environmental aggravating factors related to dry eye disease.
Secondary outcomes
1
Description
Tear break up time (TBUT)
Timepoint
Measurement of TBUT at baseline (prior to the intervention) and at weeks 4, 8, and 12 after initiation of the drug or placebo.
Method of measurement
The time interval between fluorescein staining of the conjunctival cul-de-sac and the appearance of the first dry spot on the corneal surface.
2
Description
The number of stained spots on the cornea and conjunctiva observed during fluorescein staining.
Timepoint
Measurement of Fluorescein staining at baseline (prior to the intervention) and at weeks 4, 8, and 12 after initiation of the drug or placebo.
Method of measurement
The number of stained spots on the cornea and conjunctiva, evaluated according to the Oxford grading scale.
3
Description
The length in millimeters of a standard filter paper strip wetted by the patient’s tears after 5 minutes (Schirmer test)
Timepoint
Measurement of Schirmer test at baseline (prior to the intervention) and at weeks 4, 8, and 12 after initiation of the drug or placebo.
Method of measurement
Schirmer test: The length, in millimeters, of a standard Schirmer strip wetted by the patient's tear fluid after 5 minutes
4
Description
Dry eye questionnaire (DEQ5) score
Timepoint
Measurement of DEQ5 score at baseline (prior to the intervention) and at weeks 4, 8, and 12 after initiation of the drug or placebo.
Method of measurement
A self-administered questionnaire used to assess the presence and severity of dry eye symptoms.
5
Description
Meibomian gland expressibility
Timepoint
Measurement of Meibomian gland expressibility at baseline (prior to the intervention) and at weeks 4, 8, and 12 after initiation of the drug or placebo.
Method of measurement
Evaluation of the meibomian glands in the lower eyelid is performed by applying approximately 1.20 grams per square millimeter of pressure to the nasal, central, and temporal regions. Lipid secretion from the gland orifices is assessed and graded on a scale from 0 to 4:Grade 0: secretion from more than 75% of the glands; Grade 1: secretion from 50–75% of glands; Grade 2: secretion from 25–50% of glands; Grade 3: secretion from less than 25% of glands; Grade 4: no secretion from any gland. In addition, the quality of the expressed meibum is graded as follows: Grade 0: clear; Grade 1: cloudy; Grade 2: cloudy with debris or granular texture;G rade 3: thick and toothpaste-like; Grade 4: waxy
6
Description
Tear meniscus height
Timepoint
Measurement of Tear meniscus height at baseline (prior to the intervention) and at weeks 4, 8, and 12 after initiation of the drug or placebo.
Method of measurement
Measurement of tear film height using the slit-lamp biomicroscope.
Intervention groups
1
Description
Intervention group: one affected eye of each patient will be enrolled in the study as the treatment eye. In addition to standard care, including eyelid hygiene and warm compresses, topical Atorvastatin eye drop (50 µM) will be administered to the treatment eye at a dosage of one drop four times a day."
Category
Treatment - Drugs
2
Description
Control group: In the control group, only one affected eye of each patient will be included to receive the placebo. In addition to routine treatment, including eyelid hygiene, a topical placebo drop identical in appearance and composition to the intervention drop but without the active ingredient atorvastatin will be administered to the study eye, one drop four times daily