Topical Statin Eye Drop in the Management of the Dry Eye

Dry Eye Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06208384
• Other study ID #: 14023
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: January 4, 2024
• Est. completion date: February 4, 2025

Study information

• Verified date: January 2024
• Source: Shahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: February 4, 2025
• Est. primary completion date: January 4, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
Iran, Islamic Republic of	Ophthalmic Research Center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from tear break up time at week 4 follow up	Time taken for the first dry spot to appear on the cornea after a complete blink will be assessed by slit lamp at baseline and week 4 follow up after completion of prescription period (8 week)	Baseline and week 4 follow up
Primary	Change from tear break up time at week 8 follow up	Time taken for the first dry spot to appear on the cornea after a complete blink will be assessed by slit lamp at baseline and week 8 follow up after completion of prescription period (8 week)	Baseline and week 8 follow up
Primary	Change from tear break up time at week 12 follow up	Time taken for the first dry spot to appear on the cornea after a complete blink will be assessed by slit lamp at baseline and week 12 follow up after completion of prescription period (8 week)	Baseline and week 12 follow up
Secondary	Change from Ocular Surface Disease Index at week 4 follow up	Ocular Surface Disease Index (OSDI) Questionnaire will be completed by participants at baseline and week 4 follow up after completion of prescription period (8 week)	Baseline and week 4 follow up
Secondary	Change from Ocular Surface Disease Index at week 8 follow up	Ocular Surface Disease Index (OSDI) Questionnaire will be completed by participants at baseline and week 8 follow up after completion of prescription period (8 week)	Baseline and week 8 follow up
Secondary	Change from Ocular Surface Disease Index at week 12 follow up	Ocular Surface Disease Index (OSDI) Questionnaire will be completed by participants at baseline and week 12 follow up after completion of prescription period (8 week)	Baseline and week 12 follow up
Secondary	Change from dry eye score at week 4 follow up	Dry Eye Questionnaire will be completed by participants at baseline and week 4 follow up after completion of prescription period (8 week)	Baseline and week 4 follow up
Secondary	Change from dry eye score at week 8 follow up	Dry Eye Questionnaire will be completed by participants at baseline and week 8 follow up after completion of prescription period (8 week)	Baseline and week 8 follow up
Secondary	Change from dry eye score at week 12 follow up	Dry Eye Questionnaire will be completed by participants at baseline and week 12 follow up after completion of prescription period (8 week)	Baseline and week 12 follow up