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IRCT20250513065716N1 IRCT 2025-09-11 Shahid Beheshti University of Medical Sciences Effect of Atorvastatin in treatment of MGD Efficacy and safety of topical statin eye drop compared to placebo in the management of dry eye associated with meibomian gland dysfunction 2025-09-23 anticipated 40 Complete https://irct.ir/trial/83561 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 2-3 Meibomian Gland Dysfunction. Intervention 1: 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.". Intervention 2: 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Salar Bahrami
No. 65, 9th Boostan avenue, Pasdaran street, Tehran
Tehran Iran (Islamic Republic of) 1666718174 +98 914 972 8056 salar7575@gmail.com Shahid Beheshti University of Medical Sciences scientific Kiana Hassanpour
Shahid Labbafi Nejad hospital, Boostan 9 street, Pasdaran street, Tehran, Iran
Tehran Iran (Islamic Republic of) 1666663111 +98 21 23601 kiana.hassanpour@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 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 40 years 65 years Both 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 Treatment - Drugs Placebo 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." 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 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. 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. 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. 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. 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. 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. 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. Shahid Beheshti University of medical sciences Approved 2023-10-08 Ethics committee of Shahid Beheshti University of Medical Sciences 6th Floor, University Headquarters Building No. 2, Shahid Beheshti University of Medical Sciences and Health Services, E'arabi Street, Yemen Street, Shahid Chamran Expressway Tehran Tehran Iran (Islamic Republic of)