Topical Statin Eye Drop in the Management of the Dry Eye
NCT ID: NCT06208384
Last Updated: 2024-01-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2024-01-04
2025-02-04
Brief Summary
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For patients in the intervention group, in addition to standard treatment, including eyelid hygiene and the use of artificial tears, a topical drop of Atorvastatin (50 microM) will be administered, one drop eight times a day in both eyes. In the control group, a placebo will be used in the same manner. The patients will be unaware of their assigned group.
Clinical examinations, including Schirmer's test, tear breakup time, fluorescein staining, and completion of the dry eye syndrome questionnaire and dry eye questionnaire, will be conducted before and after the intervention to assess the level of eye dryness.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Statin eye drop
Use of topical atorvastatin eye drop 8 times a day; in addition to eyelid hygiene and artificial tear drops (8 weeks)
Statin eye drop
Use of topical atorvastatin eye 8 times a day; in addition to eyelid hygiene and artificial tear drops (8 weeks)
Control
Use of topical eye drops as a placebo same as intervention group but without active ingredient of atorvastatin 8 times a day; in addition to eyelid hygiene and artificial tear drops (8 weeks)
Placebo
Use of topical eye drops as a placebo same as intervention group but without active ingredient of atorvastatin 8 times a day; in addition to eyelid hygiene and artificial tear drops (8 weeks)
Interventions
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Statin eye drop
Use of topical atorvastatin eye 8 times a day; in addition to eyelid hygiene and artificial tear drops (8 weeks)
Placebo
Use of topical eye drops as a placebo same as intervention group but without active ingredient of atorvastatin 8 times a day; in addition to eyelid hygiene and artificial tear drops (8 weeks)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Dry eye induced by Meibomian gland dysfunction
* Tear break up time less than 10 seconds
Exclusion Criteria
* Coagulopathies
* Use of anticoagulant medication
* Use of Peptic ulcer disease
* History of ocular surgeries in the last 3 months
* History of any ocular Malignancies
* History of ocular trauma
* History of statin use
20 Years
ALL
No
Sponsors
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Shahid Beheshti University of Medical Sciences
OTHER
Responsible Party
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Mohammadali Javadi, MD
Head of Ophthalmic Research Center
Principal Investigators
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Kiana Hassanpour
Role: PRINCIPAL_INVESTIGATOR
Ophthalmic Research Center
Locations
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Ophthalmic Research Center
Tehran, , Iran
Countries
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Other Identifiers
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14023
Identifier Type: -
Identifier Source: org_study_id
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