NCT06208384

Topical Statin Eye Drop in the Management of the Dry Eye

Efficacy and Safety of Topical Statin Eye Drop in the Management of Dry Eye Associated With Meibomian Gland Dysfunction

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Shahid Beheshti University of Medical Sciences · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Dry Eye Disease

Interventions

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

Timeline

• Start date: 2024-01-04
• Primary completion: 2025-01-04
• Completion: 2025-02-04
• First posted: 2024-01-17
• Last updated: 2024-01-17

Locations

1 site across 1 country: Iran