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New treatment option for Dry Eye Disease (DED)
Official title The Effect of 0.1% Topical Ciclosporin A for 12-weeks on the Eye Surface Immune Cells in Dry Eyes
ClinicalTrials.gov ID: NCT06898853
What this study is testing
What is 0.1% Ciclosporin A eye drops?
0.1% Ciclosporin A eye drops is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for dry eye disease (ded).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Dry eye disease (DED) is a common, long-lasting condition that affects the surface of the eye. It happens when there's a problem with tear production or quality, which can lead to inflammation and discomfort.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 18 years of age and above
- Participants should meet any two of the following DED diagnostic criteria: i) ocular surface disease index score of ≥23 and ii) Oxford staining score...
You likely can't join if
- Participants currently using or with previous use of steroids, ciclosporin, lifitegrast or any anti-inflammatory eye drops in the last 6 months.
- Participants with systemic CsA or tacrolimus
- Known hypersensitivity or contraindication to the study medication or any of its ingredients.
- Active intraocular inflammation.
- Contact lens wear or the use of contact lenses in the last 4 weeks.
- Active eye infections or history of critical illness.
See the full eligibility criteria
- 18 years of age and above
- Participants should meet any two of the following DED diagnostic criteria: i) ocular surface disease index score of ≥23 and ii) Oxford staining score of ≥1 iii) Tear meniscus height \< 0.2 mm.
- Participants currently using or with previous use of steroids, ciclosporin, lifitegrast or any anti-inflammatory eye drops in the last 6 months.
- Participants with systemic CsA or tacrolimus
- Known hypersensitivity or contraindication to the study medication or any of its ingredients.
- Active intraocular inflammation.
- Contact lens wear or the use of contact lenses in the last 4 weeks.
- Active eye infections or history of critical illness.
- DED secondary to Steven-Johnson syndrome and cicatricial conjunctival disease.
- Participants with other ocular co-morbidities and medications for glaucoma.
- Participants with previous history of ocular surgery in the past 6 months.
- Any other active or inactive systemic condition, structural abnormality such as eyelid malposition's that in the judgment of the investigator could confound study assessments or limit compliance.
- Pregnant/breastfeeding women
The study team makes the final eligibility decision.
Where it's taking place
- Sydney, New South Wales, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sydney, New South Wales, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.