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Tests treatment safety and results for Moderate to Severe Dry Eye
Official title A Study of the Efficacy and Safety of Cyclosporin Ophthalmic Gel in Subjects With Moderate to Severe Dry Eye Disease
ClinicalTrials.gov ID: NCT06766357
What this study is testing
What is Cyclosporine ophthalmic gel?
Cyclosporine ophthalmic gel is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for moderate to severe dry eye.
Also referred to as Cyclosporine.
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
- This study is a multicenter, randomized, double-blind, placebo-controlled, superiority design Phase III clinical trial. The primary objective is to evaluate the efficacy and safety of cyclosporine ophthalmic gel versus placebo in the treatment of moderate to severe dry eye for 84 days.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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
- aged ≥ 18 years old, males or females.
- people complained of ocular dryness in both eyes for at least 6 months at Visit 1.
- Eye dryness score(EDS)(evaluated on a 0-100 VAS score) ≥40 at Visit 1 and Visit 2.
- Ocular Surface Disease Index (OSDI) score ≥13 at Visit 1 and Visit 2.
- Total corneal fluorescein staining score (tCFS) ≥2 in either eye and ≥1 in at least one region at Visit 1 and Visit 2.
You likely can't join if
- people with severe dry eye requiring surgical treatment.
- Systemic use of retinoids within the 12 months prior to Visit 1.
- people who have had intraocular surgery within 12 months prior to Visit 1 or who require intraocular surgery during the study; or people who have had...
- people treated with permanent lacrimal duct embolization; or people treated with temporary lacrimal duct embolization within 6 months prior to Visit...
- people with dry eye correlated with operation；
- people who had worn corneal contact lens within 3 months prior to Visit 1.
See the full eligibility criteria
- aged ≥ 18 years old, males or females.
- people complained of ocular dryness in both eyes for at least 6 months at Visit 1.
- Eye dryness score(EDS)(evaluated on a 0-100 VAS score) ≥40 at Visit 1 and Visit 2.
- Ocular Surface Disease Index (OSDI) score ≥13 at Visit 1 and Visit 2.
- Total corneal fluorescein staining score (tCFS) ≥2 in either eye and ≥1 in at least one region at Visit 1 and Visit 2.
- Schirmer I test (without anesthesia) ≤ 5 mm/5 min in either eye at Visit 1 and Visit 2.
- people with moderate and severe dry eye in both eyes at Visit 1 and Visit 2:
- Moderate: ≥1 quadrant and no more than 2 quadrants of corneal damage and/or ≥5 and \<30 corneal fluorescein staining spots on slit lamp microscopy;
- Severe: ≥2 quadrants of corneal damage and/or ≥30 corneal fluorescence staining spots on slit lamp microscopy.
- people with severe dry eye requiring surgical treatment.
- Systemic use of retinoids within the 12 months prior to Visit 1.
- people who have had intraocular surgery within 12 months prior to Visit 1 or who require intraocular surgery during the study; or people who have had eyelid surgery within 6 months prior to Visit 1.
- people treated with permanent lacrimal duct embolization; or people treated with temporary lacrimal duct embolization within 6 months prior to Visit 1.
- people with dry eye correlated with operation；
- people who had worn corneal contact lens within 3 months prior to Visit 1.
- Those who have used cyclosporine preparations ocularly or systemically within 1 month prior to visit 1.
- Those who have used lifitegrast eye drops or tacrolimus eye drops ocularly within 1 month prior to visit 1.
- people with dry eye secondary to scarring (e.g., radiation exposure, ocular chemical burns, Stevens-Johnson syndrome, keloid pemphigoid, conjunctival scarring) or severe conjunctival cup cells destruction (e.g., vitamin...
- Those with significant eyelid margin inflammation or meibomian gland dysfunction that, in the opinion of the investigator, may affect the outcome of the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Xiamen, Fujian, China
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 Xiamen, Fujian, China. 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.