Dry Eye DiseasePhase 1/2NCT06208384
Topical Statin Eye Drop in the Management of the Dry Eye
A Phase 1/2 study testing Statin eye drop in people with Dry Eye Disease, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- Statin eye drop
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteIran
- Study dates
- 4 Jan 2024to 4 Feb 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>20 years old
- Dry eye induced by Meibomian gland dysfunction
- Tear break up time less than 10 seconds
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Topical Statin Eye Drop in the Management of Dry Eye Associated With Meibomian Gland Dysfunction
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
- Being tested
- Statin eye drop, Placebo
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Statin eye dropDrug
Also called Tiam Darou
Use of topical atorvastatin eye 8 times a day; in addition to eyelid hygiene and artificial tear drops (8 weeks)
PlaceboDrug
Also called Tiam Darou
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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Statin eye drop |
| 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) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: Baseline and week 12 follow up
Secondary outcomes (6)
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)
Measured: Baseline and week 4 follow up
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Baseline and week 12 follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start4 Jan 2024
- Primary completion4 Jan 2025 (estimated)
- Study completion4 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammadali Javadi, MD, Shahid Beheshti University of Medical Sciences
- Investigators
- Kiana Hassanpour, Principal investigator, Ophthalmic Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06208384
- Sponsor's protocol ID
- 14023
- Status last verified
- Jan 2024
- First submitted
- 6 Jan 2024
- Last updated
- 17 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Topical Statin Eye Drop in the Management of Dry Eye Associated With Meibomian Gland Dysfunction
- ClinicalTrials.gov ID
- NCT06208384
- Acronym / sponsor ID
- 14023
- Conditions
- Dry Eye Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- 4 Jan 2024 (actual)
- Primary completion
- 4 Jan 2025 (estimated)
- Study completion
- 4 Feb 2025 (estimated)
- First posted
- 17 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Statin eye drop | Experimental | Drug: Statin eye dropUse of topical atorvastatin eye drop 8 times a day; in addition to eyelid hygiene and artificial tear drops (8 weeks) |
| Control | Placebo comparator | Drug: PlaceboUse 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) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age>20 years old
- Dry eye induced by Meibomian gland dysfunction
- Tear break up time less than 10 seconds
Key exclusion criteria (8 listed)
- Hematologic disorders
- Coagulopathies
- Use of anticoagulant medication
- Use of Peptic ulcer disease
- History of ocular surgeries in the last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Statin eye dropAlso: Tiam DarouUse of topical atorvastatin eye 8 times a day; in addition to eyelid hygiene and artificial tear drops (8 weeks) | Drug | Statin eye drop |
| PlaceboAlso: Tiam DarouUse 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) | Drug | Control |
Primary outcome
Change from tear break up time at week 4 follow up
Time frame: 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
Time frame: 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
Time frame: 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)
6 secondary outcomes
Change from Ocular Surface Disease Index at week 4 follow up
Time frame: Baseline and week 4 follow up
Change from Ocular Surface Disease Index at week 8 follow up
Time frame: Baseline and week 8 follow up
Change from Ocular Surface Disease Index at week 12 follow up
Time frame: Baseline and week 12 follow up
Change from dry eye score at week 4 follow up
Time frame: Baseline and week 4 follow up
Change from dry eye score at week 8 follow up
Time frame: Baseline and week 8 follow up
Change from dry eye score at week 12 follow up
Time frame: Baseline and week 12 follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kiana Hassanpour principal investigator
Ophthalmic Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Statin eye drop in people with Dry Eye Disease, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from tear break up time at week 4 follow up (time frame: Baseline and week 4 follow up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.