Dry Eye Disease (DED)Phase 4NCT06876116
Once-daily Fluorometholone vs Twice-daily Cyclosporine in Dry Eye Disease
A Phase 4 study testing Fluorometholone 0.1% ophthalmic solution and Cyclosporine 0.05% eye drops in people with Dry Eye Disease (DED), run by Korea University Anam Hospital at 1 site in South Korea.
Trial summary
This study compares the therapeutic effects of once-daily fluorometholone 0.1% versus twice-daily cyclosporine 0.05% after short-term fluorometholone induction treatment in dry eye disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease (DED)
- What is being tested?
- Fluorometholone 0.1% ophthalmic solution and Cyclosporine 0.05% eye drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2022to 24 May 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- participants aged 18 years or older
- complaint of dry eye symptoms for 6 months or longer at screening
- ocular surface disease index (OSDI) score of 33 or higher
- tear film breakup time of 7 seconds or less
Who cannot join
- abnormal lid anatomy or active blepharitis
- severe systemic autoimmune diseases
- received permanent lacrimal plug within 3 months
- DED secondary to alkali burns, cicatricial pemphigoid, or Stevens-Johnson syndrome
- ocular/periocular malignancy
- active ocular allergies or allergy to the study drug or its components
Show all 12Show fewer
- active infection
- intraocular surgery or ocular laser surgery within 6 months
- uncontrolled systemic disease or history of herpetic keratitis
- contact lens user
- intraocular pressure >25mmHg
- pregnancy or current breast-feeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Therapeutic Effects of Once-daily Fluorometholone 0.1% Versus Twice-daily Cyclosporine 0.05% in Patients With Dry Eye Disease: A Randomized, Assessor-blinded Clinical Trial
This study compares the therapeutic effects of once-daily fluorometholone 0.1% versus twice-daily cyclosporine 0.05% after short-term fluorometholone induction treatment in dry eye disease.
- Conditions
- Dry Eye Disease (DED)
- Being tested
- Fluorometholone 0.1% ophthalmic solution, Cyclosporine 0.05% eye drops
- 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.
Fluorometholone 0.1% ophthalmic solutionDrug
After induction therapy with fluorometholone 0.1% four times a day for 4 weeks, patients continued with fluorometholone 0.1% once a day for 8 weeks.
Cyclosporine 0.05% eye dropsDrug
Also called fluorometholone 0.1%
After induction therapy with fluorometholone 0.1% four times a day for 4 weeks, patients continued with cyclosporine 0.05% twice a day for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| once-daily fluorometholone 0.1% group | Active comparator | After induction therapy with fluorometholone 0.1% four times a day for 4 weeks, patients continued with fluorometholone 0.1% once a day for 8 weeks. Receives: Drug: Fluorometholone 0.1% ophthalmic solution |
| twice-daily cyclosporine 0.05% group | Active comparator | After induction therapy with fluorometholone 0.1% four times a day for 4 weeks, patients continued with cyclosporine 0.05% twice a day for 8 weeks. Receives: Drug: Cyclosporine 0.05% eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Surface Disease Index (OSDI) score
Score 0-100
Measured: From enrollment to the end of treatment at 12 weeks
tear breakup time (TBUT)
Unit: Seconds
Measured: From enrollment to the end of treatment at 12 weeks
corneal staining score (CSS)
National Eye Institute Scale, 0-15
Measured: From enrollment to the end of treatment at 12 weeks
Schirmer's test
Unit: mm/5 min
Measured: From enrollment to the end of treatment at 12 weeks
Meibomian gland dysfunction grade (0-4)
Scale 0-4
Measured: From enrollment to the end of treatment at 12 weeks
tear matrix metalloproteinase-9 (MMP-9) grade
Grade 0-4
Measured: From enrollment to the end of treatment at 12 weeks
tear osmolarity
Unit: mOsm/L
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (2)
Tear IL-6 levels
Unit: pg/mL
Measured: From enrollment to the end of treatment at 12 weeks
tear 8-oxo-dG levels
Unit: pg/mL
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start1 Sep 2022
- Primary completion1 Mar 2024
- Study completion24 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye Disease (DED)Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Taejoon Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Dong Hyun Kim, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06876116
- Sponsor's protocol ID
- 2022AN0569
- Status last verified
- Mar 2025
- First submitted
- 25 Feb 2025
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data that support the findings of this study are not openly available due to reasons of sensitivity and may available from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Therapeutic Effects of Once-daily Fluorometholone 0.1% Versus Twice-daily Cyclosporine 0.05% in Patients With Dry Eye Disease: A Randomized, Assessor-blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT06876116
- Acronym / sponsor ID
- 2022AN0569
- Conditions
- Dry Eye Disease (DED)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Collaborators
- Taejoon Pharmaceutical Co., Ltd.
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 24 May 2024 (actual)
- First posted
- 14 Mar 2025 (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.
This study compares the therapeutic effects of once-daily fluorometholone 0.1% versus twice-daily cyclosporine 0.05% after short-term fluorometholone induction treatment in dry eye disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| once-daily fluorometholone 0.1% group | Active comparator | Drug: Fluorometholone 0.1% ophthalmic solutionAfter induction therapy with fluorometholone 0.1% four times a day for 4 weeks, patients continued with fluorometholone 0.1% once a day for 8 weeks. |
| twice-daily cyclosporine 0.05% group | Active comparator | Drug: Cyclosporine 0.05% eye dropsAfter induction therapy with fluorometholone 0.1% four times a day for 4 weeks, patients continued with cyclosporine 0.05% twice a day for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- participants aged 18 years or older
- complaint of dry eye symptoms for 6 months or longer at screening
- ocular surface disease index (OSDI) score of 33 or higher
- tear film breakup time of 7 seconds or less
Key exclusion criteria (12 listed)
- abnormal lid anatomy or active blepharitis
- severe systemic autoimmune diseases
- received permanent lacrimal plug within 3 months
- DED secondary to alkali burns, cicatricial pemphigoid, or Stevens-Johnson syndrome
- ocular/periocular malignancy
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 |
|---|---|---|
| Fluorometholone 0.1% ophthalmic solutionAfter induction therapy with fluorometholone 0.1% four times a day for 4 weeks, patients continued with fluorometholone 0.1% once a day for 8 weeks. | Drug | once-daily fluorometholone 0.1% group |
| Cyclosporine 0.05% eye dropsAlso: fluorometholone 0.1%After induction therapy with fluorometholone 0.1% four times a day for 4 weeks, patients continued with cyclosporine 0.05% twice a day for 8 weeks. | Drug | twice-daily cyclosporine 0.05% group |
Primary outcome
Ocular Surface Disease Index (OSDI) score
Time frame: From enrollment to the end of treatment at 12 weeks
Score 0-100
tear breakup time (TBUT)
Time frame: From enrollment to the end of treatment at 12 weeks
Unit: Seconds
corneal staining score (CSS)
Time frame: From enrollment to the end of treatment at 12 weeks
National Eye Institute Scale, 0-15
Schirmer's test
Time frame: From enrollment to the end of treatment at 12 weeks
Unit: mm/5 min
Meibomian gland dysfunction grade (0-4)
Time frame: From enrollment to the end of treatment at 12 weeks
Scale 0-4
tear matrix metalloproteinase-9 (MMP-9) grade
Time frame: From enrollment to the end of treatment at 12 weeks
Grade 0-4
tear osmolarity
Time frame: From enrollment to the end of treatment at 12 weeks
Unit: mOsm/L
2 secondary outcomes
Tear IL-6 levels
Time frame: From enrollment to the end of treatment at 12 weeks
tear 8-oxo-dG levels
Time frame: From enrollment to the end of treatment at 12 weeks
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 14 Mar 2025.
- Individual participant dataSharing planned: No. The data that support the findings of this study are not openly available due to reasons of sensitivity and may available from the corresponding author upon reasonable request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Fluorometholone 0.1% ophthalmic solution and Cyclosporine 0.05% eye drops in people with Dry Eye Disease (DED), run by Korea University Anam Hospital 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 4 inclusion and 12 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 14 Mar 2025. 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?
Ocular Surface Disease Index (OSDI) score (time frame: From enrollment to the end of treatment at 12 weeks). The study lists 7 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 14 Mar 2025.