Recruiting PHASE3 Vernal Keratoconjunctivitis

New treatment option for Vernal Keratoconjunctivitis

Official title 3% Diquafosol Ophthalmic Solution for Active Moderate-to-Severe Vernal Keratoconjunctivitis

ClinicalTrials.gov ID: NCT06903884

What this study is testing

What is 3% Diquafosol ophthalmic solution and 0.1% Cyclosporin A cationic ophthalmic emulsion?

3% Diquafosol ophthalmic solution and 0.1% Cyclosporin A cationic ophthalmic emulsion is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for vernal keratoconjunctivitis.

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
The aim of the study is to investigate whether patients with moderate-to-severe VKC and keratitis will benefit from the addition of Diquafosol ophthalmic solution in terms of symptoms and signs of VKC, tear film metrics, ocular surface inflammation and quality of life. Potential beneficial effect of Diquafosol treatment on top of current standard use of topical immunosuppressant therapy in VKC would be studied.
  • Phase 3: a large, late-stage study
  • 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 6 and older

You may be able to join if

  • Subject at least aged 6 and above
  • Clinical diagnosis of vernal keratoconjunctivitis
  • Evidence of active moderate-to-severe disease: At least Grade 2 on the Bonini scale of VKC clinical presentation (moderate-to-severe) [38].
  • Evidence of keratitis: At least Grade 1 on the Modified Oxford scale for cornea fluorescein staining as reported by Bron et al [39].
  • Experienced 1 or more recurrences of VKC during the previous year

You likely can't join if

  • Nasolacrimal duct obstruction
  • Impaired blinking function
  • Active ocular infection or history of ocular herpes, varicella zoster or vaccinia virus infection
  • Any ocular disease that would require topical ocular treatment during the study
  • Use of cyclosporin A or tacrolimus eyedrops, or use of systemic immunosuppressants within 3 months before enrolment
  • Any ocular surgery within 6 months before enrolment

The study team makes the final eligibility decision.

Where it's taking place

  • Hong Kong, Hong Kong

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, 6 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Hong Kong, Hong Kong. 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.