Topical Statin Eye Drop in the Management of the Dry Eye

Shahid Beheshti University of Medical Sciences

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Dry Eye Disease

Treatments: Drug: Placebo; Drug: Statin eye drop

Study type: Interventional

Funder types: Other

Identifiers

NCT06208384

14023

Details and patient eligibility

About

In the first stage, to evaluate the safety of the topical medication produced by Sina Pharmaceuticals, this medication is experimentally tested on 10 volunteer patients. If no side effects occur, eligible patients are enrolled in the study after examination by a specialist. The second stage is a randomized, double-blind clinical trial, during which selected patients are randomly assigned to the control and intervention groups.

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.

Enrollment: 20 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age>20 years old
• Dry eye induced by Meibomian gland dysfunction
• Tear break up time less than 10 seconds

Exclusion criteria

• Hematologic disorders
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

Statin eye drop

Experimental group

Description:

Use of topical atorvastatin eye drop 8 times a day; in addition to eyelid hygiene and artificial tear drops (8 weeks)

Treatment:

Drug: Statin eye drop

Control

Placebo Comparator group

Description:

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)

Treatment:

Drug: Placebo