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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Statin eye drop | Experimental | Use of topical atorvastatin eye drop 8 times a day; in addition to eyelid hygiene and artificial tear drops (8 weeks) |
|
| Control | Placebo Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Statin eye drop | Drug | Use of topical atorvastatin eye 8 times a day; in addition to eyelid hygiene and artificial tear drops (8 weeks) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change from Ocular Surface Disease Index at week 8 follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kiana Hassanpour | Ophthalmic Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ophthalmic Research Center | Tehran | Iran |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Placebo | Drug | 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) |
|
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |