Dry Eye Disease
Conditions
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.
Interventions
DRUGStatin eye drop
Use of topical atorvastatin eye 8 times a day; in addition to eyelid hygiene and artificial tear drops (8 weeks)
DRUGPlacebo
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)
Sponsors
Shahid Beheshti University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from tear break up time at week 4 follow up | Baseline and 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) |
| Change from tear break up time at week 8 follow up | Baseline and 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) |
| Change from tear break up time at week 12 follow up | Baseline and 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from dry eye score at week 4 follow up | Baseline and 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) |
| Change from Ocular Surface Disease Index at week 4 follow up | Baseline and 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) |
| Change from dry eye score at week 12 follow up | Baseline and 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) |
| Change from dry eye score at week 8 follow up | Baseline and 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) |
| Change from Ocular Surface Disease Index at week 8 follow up | Baseline and 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) |
| Change from Ocular Surface Disease Index at week 12 follow up | Baseline and 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) |
Countries
Iran
Outcome results
None listed