Clinical trial NCT06208384: Topical Statin Eye Drop in the Management of the Dry Eye
Official title: Efficacy and Safety of Topical Statin Eye Drop in the Management of Dry Eye Associated With Meibomian Gland Dysfunction
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Dry Eye Disease
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from tear break up time at week 4 follow up
timeFrame: Baseline and week 4 follow up
measure: Change from tear break up time at week 8 follow up
timeFrame: Baseline and week 8 follow up
measure: Change from tear break up time at week 12 follow up
timeFrame: Baseline and week 12 follow up
Secondary outcomes:
measure: Change from Ocular Surface Disease Index at week 4 follow up
timeFrame: Baseline and week 4 follow up
measure: Change from Ocular Surface Disease Index at week 8 follow up
timeFrame: Baseline and week 8 follow up
measure: Change from Ocular Surface Disease Index at week 12 follow up
timeFrame: Baseline and week 12 follow up
measure: Change from dry eye score at week 4 follow up
timeFrame: Baseline and week 4 follow up
measure: Change from dry eye score at week 8 follow up
timeFrame: Baseline and week 8 follow up
measure: Change from dry eye score at week 12 follow up
timeFrame: Baseline and week 12 follow up
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Ophthalmic Research Center
Study officials:
affiliation: Ophthalmic Research Center
name: Kiana Hassanpour
role: PRINCIPAL_INVESTIGATOR
References: