Dry Eye SyndromesPhase 4NCT04426240
The Effect of Cyclosporin Before Cataract Surgery
A Phase 4 study testing Cyclosporine microemulsion in people with Dry Eye Syndromes, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
To evaluate the effect of cyclosporine eye drop before cataract surgery for the prevention of post cataract surgery dry eye syndrome. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- Cyclosporine microemulsion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Aug 2020to 19 Apr 2022
- Phase
- Phase 4
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 21+ adult men and women
- Those who are scheduled to undergo cataract surgery due to a diagnosis of cataract
- Corneal fluorescein staining score (Oxford) is II or less
- Preoperative MMP-9 positive
- Those who have not used the trial and the test (cyclosporine) for at least 1 month before surgery.
- Those who have voluntarily written consent to participate in this clinical trial
Who cannot join
- Those who have used systemic or topical cyclosporine within 4 weeks
- Use of eye drops for more than 4 weeks (disorders, allergies, eye inflammation / infection, etc.) other than the current dry eye syndromes
- Patients who have systemic or ocular disorders or conditions (eye surgery, trauma, disease) that can influence the results of this trial.
- Abnormal eyelid function
- An eye disease that can impair the function of the corneal sensation: herpes keratopathy, conjunctival wounds due to scarring conjunctivitis, pterygium, pinguecula, diabetic keratitis, keratoconus , corneal transplant status
- Patients with active eye infections
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- Patients with conflicts with this clinical trial
- Pregnant and lactating mothers
- Patients who are determined to be inappropriate by other investigators
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study of Use of Cyclosporin Eye Before Cataract Surgery for the Prevention of Dry Eye
To evaluate the effect of cyclosporine eye drop before cataract surgery for the prevention of post cataract surgery dry eye syndrome.
- Conditions
- Dry Eye Syndromes
- Being tested
- Cyclosporine microemulsion
- 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.
Cyclosporine microemulsionDrug
Also called Cyporin
Intervention group receives topical cyclosporine dry eye treatment before cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| Cyclosporine | Active comparator | Subject who use cyclosporine and hyaluronate artificial tear 1 month before cataract surgery Receives: Drug: Cyclosporine microemulsion |
| non-Cyclosporine | No intervention | Subject who use only hyaluronate eye drop 1 month before cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal florescence staining score
Standardized corneal staining score (NEI score, National eye institute score) : dividing the cornea into five sections and assigning a value from 0 (absent) to 3 (severe) to each section, based on the amount, size, and confluence of the PEE, for a maximum of 15 points.
Measured: 1 month
Secondary outcomes (2)
tear break-up time
Time to break tear film
Measured: 1 month
Schirmer test
Tear secretion test
Measured: 1 montn
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start3 Aug 2020
- Primary completion26 Jan 2022
- Study completion19 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, tae-young chung, Samsung Medical Center
- Investigators
- Tae-Young Chung, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04426240
- Sponsor's protocol ID
- 2019-11-203
- Status last verified
- May 2022
- First submitted
- 8 Jun 2020
- Last updated
- 13 May 2022
- 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 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Use of Cyclosporin Eye Before Cataract Surgery for the Prevention of Dry Eye
- ClinicalTrials.gov ID
- NCT04426240
- Acronym / sponsor ID
- 2019-11-203
- Conditions
- Dry Eye Syndromes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 26 Jan 2022 (actual)
- Study completion
- 19 Apr 2022 (actual)
- First posted
- 11 Jun 2020 (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.
To evaluate the effect of cyclosporine eye drop before cataract surgery for the prevention of post cataract surgery dry eye syndrome.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cyclosporine | Active comparator | Drug: Cyclosporine microemulsionSubject who use cyclosporine and hyaluronate artificial tear 1 month before cataract surgery |
| non-Cyclosporine | No intervention | –Subject who use only hyaluronate eye drop 1 month before cataract surgery |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 21+ adult men and women
- Those who are scheduled to undergo cataract surgery due to a diagnosis of cataract
- Corneal fluorescein staining score (Oxford) is II or less
- Preoperative MMP-9 positive
- Those who have not used the trial and the test (cyclosporine) for at least 1 month before surgery.
Key exclusion criteria (9 listed)
- Those who have used systemic or topical cyclosporine within 4 weeks
- Use of eye drops for more than 4 weeks (disorders, allergies, eye inflammation / infection, etc.) other than the current dry eye syndromes
- Patients who have systemic or ocular disorders or conditions (eye surgery, trauma, disease) that can influence the results of this trial.
- Abnormal eyelid function
- An eye disease that can impair the function of the corneal sensation: herpes keratopathy, conjunctival wounds due to scarring conjunctivitis, pterygium, pinguecula, diabetic keratitis, keratoconus , corneal transplant status
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 |
|---|---|---|
| Cyclosporine microemulsionAlso: CyporinIntervention group receives topical cyclosporine dry eye treatment before cataract surgery | Drug | Cyclosporine |
Primary outcome
Corneal florescence staining score
Time frame: 1 month
Standardized corneal staining score (NEI score, National eye institute score) : dividing the cornea into five sections and assigning a value from 0 (absent) to 3 (severe) to each section, based on the amount, size, and confluence of the PEE, for a maximum of 15 points.
2 secondary outcomes
tear break-up time
Time frame: 1 month
Schirmer test
Time frame: 1 montn
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
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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.
Tae-Young Chung principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cyclosporine microemulsion in people with Dry Eye Syndromes, run by Samsung Medical Center at 1 site in South Korea.
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 6 inclusion and 9 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: finished, as of the sponsor's last update on 13 May 2022. 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 South Korea. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Corneal florescence staining score (time frame: 1 month). 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 13 May 2022.