Authorised Therapeutic exploratory (Phase II) Vernal Keratoconjunctivitis (VKC)

A Study to Compare the Effectiveness and Safety of T1695 (0.1% Tacrolimus) Versus Ciclosporin in Participants With Moderate to Severe Vernal Keratoconjunctivitis

EU CTIS ID: 2025-521567-12-00

What this study is testing

To compare the efficacy of T1695 0.1% ophthalmic suspension twice a day (BID) versus Ciclosporin 0.1% ophthalmic emulsion four times a day (QID) at D29 on the evolution of keratitis in participants with moderate to severe VKC.

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 1. Informed consent signed and dated*. *Obtained from the participant (if the participant is able to understand and sign it) and his/her legally acceptable relatives (mother and/or father, or tutor or witness) according to regional laws and regulations prior to the initiation of any procedure
  • At the Randomisation visit: 10. Visual Analog Scales (0-100mm VAS) of VKC symptoms (among photophobia, tearing, itching, and mucous discharge) of ≥60 mm in each eye.
  • At the Randomisation visit: 11. Participant with a Quality of Life in children with VKC (16-48 QUICK) questionnaire score from 32 to 48.
  • At the Screening visit: 2. Male or female participant from 4 years to less than 18 years old.
  • At the Screening visit: 3. Participant with grading score of 3 or 4 on the Bonini scale for clinical grading of VKC in each eye. or Participant with documented moderate to severe active VKC in each eye
  • 4. Participant who experienced at least 1 relapse of active VKC in the past year prior to enrolment. and/or who is currently: a. Refractory to anti-allergic agents or b. Cortico-dependent or c. Resistant or insufficiently responsive to ophthalmic ciclosporin.

You likely can't join if

  • 1. Ophthalmic exclusion criteria in ANY EYES Participant having experienced or experiencing at screening or randomisation visit: 1.1 Naïve participant (participant who did not receive any VKC treatment prior to enrolment) with moderate VKC defined as < 3 on the Bonini scale for clinical grading of VKC.
  • 2. Systemic/Non-ophthalmic exclusion criteria Participant having experienced or experiencing at Screening or Randomisation: 2.5 Participants with untreated asthma judged as severe by the investigator based on participant’s medical history.
  • 2. Systemic/Non-ophthalmic exclusion criteria Participant having experienced or experiencing at Screening or Randomisation: 2.6 History of malignancy within the last 5 years.
  • 3. Specific exclusion criteria regarding childbearing potential women 3.1 Pregnancy for post menarche participant (confirmed with a positive urine pregnancy test) and nursing mothers.
  • 3. Specific exclusion criteria regarding childbearing potential women 3.2 Male/female of childbearing potential who is sexually active and is not willing to use preventive measures.
  • 4. Exclusion criteria related to general conditions 4.1. History of drug or psychotropic substances consumption; drug or psychotropic substances abuse or any addiction.
See the full eligibility criteria
Who can join
  • 1. Informed consent signed and dated*. *Obtained from the participant (if the participant is able to understand and sign it) and his/her legally acceptable relatives (mother and/or father, or tutor or witness) according to regional laws and regulations prior to the initiation of any procedure
  • At the Randomisation visit: 10. Visual Analog Scales (0-100mm VAS) of VKC symptoms (among photophobia, tearing, itching, and mucous discharge) of ≥60 mm in each eye.
  • At the Randomisation visit: 11. Participant with a Quality of Life in children with VKC (16-48 QUICK) questionnaire score from 32 to 48.
  • At the Screening visit: 2. Male or female participant from 4 years to less than 18 years old.
  • At the Screening visit: 3. Participant with grading score of 3 or 4 on the Bonini scale for clinical grading of VKC in each eye. or Participant with documented moderate to severe active VKC in each eye
  • 4. Participant who experienced at least 1 relapse of active VKC in the past year prior to enrolment. and/or who is currently: a. Refractory to anti-allergic agents or b. Cortico-dependent or c. Resistant or insufficiently responsive to ophthalmic ciclosporin.
  • 5. Participant requiring therapy for moderate to severe VKC and for whom there is no contraindication to treatment with ciclosporin and tacrolimus.
  • 6. Participant able to safely discontinue the use of VKC medication (if any) for the specified wash-out period, according to the investigator’s judgment, or, if unable, participants are allowed to switch to a VKC treatment associated with a shorter washout period among the list of washout treatments shown in Table 1.
  • 7. Participant able to be enrolled early during the VKC season in order to allow the 3-month treatment Period 1 during the VKC season.
  • At the Randomisation visit: 8. Grading score of 3 or 4 on the Bonini scale for clinical grading of VKC in each eye.
  • At the Randomisation visit: 9. Severe keratitis defined as 4 or 5 on the (0-5) modified Oxford corneal fluorescein staining score in each eye.
What rules you out
  • 1. Ophthalmic exclusion criteria in ANY EYES Participant having experienced or experiencing at screening or randomisation visit: 1.1 Naïve participant (participant who did not receive any VKC treatment prior to enrolment) with moderate VKC defined as < 3 on the Bonini scale for clinical grading of VKC.
  • 2. Systemic/Non-ophthalmic exclusion criteria Participant having experienced or experiencing at Screening or Randomisation: 2.5 Participants with untreated asthma judged as severe by the investigator based on participant’s medical history.
  • 2. Systemic/Non-ophthalmic exclusion criteria Participant having experienced or experiencing at Screening or Randomisation: 2.6 History of malignancy within the last 5 years.
  • 3. Specific exclusion criteria regarding childbearing potential women 3.1 Pregnancy for post menarche participant (confirmed with a positive urine pregnancy test) and nursing mothers.
  • 3. Specific exclusion criteria regarding childbearing potential women 3.2 Male/female of childbearing potential who is sexually active and is not willing to use preventive measures.
  • 4. Exclusion criteria related to general conditions 4.1. History of drug or psychotropic substances consumption; drug or psychotropic substances abuse or any addiction.
  • 4. Exclusion criteria related to general conditions 4.2. History of drug addiction or alcohol abuse according to the Investigator’s judgement.
  • 4. Exclusion criteria related to general conditions 4.3. Inability of participant and/or relatives to understand the study procedures or to give informed consent.
  • 4. Exclusion criteria related to general conditions 4.4. Non-compliant participant and/or relatives (e.g., not willing to attend a visit or completing the self-questionnaire).
  • 4. Exclusion criteria related to general conditions 4.5. Participation in this study within the 4 weeks after the end of a previous clinical study (or within 5 half-lives of the previously tested product if longer than 4 weeks).
  • 4. Exclusion criteria related to general conditions 4.6. Participation in this study at the same time as another clinical study.
  • 1. Ophthalmic exclusion criteria in ANY EYES Participant having experienced or experiencing at screening or randomisation visit: 1.2. Any type of ocular surgery, including eye lid interventions within 6 months before the randomisation visit.
  • 4. Exclusion criteria related to general conditions 4.7. Participant previously randomised in this study.
  • 5. Exclusion criteria related to previous and concomitant treatments (medications/non-medicinal therapies/procedures) Participant with previous, current or anticipated prohibited listed treatment (or prohibited modification of treatment regimen). The prohibited treatments (or prohibited modifications of treatment regimen) and their periods of use prohibition are listed in the protocol_ Table 1. Prohibited treatments
  • 1. Ophthalmic exclusion criteria in ANY EYES Participant having experienced or experiencing 1.3. Any pre-existing eye condition (other than VKC) that could affect assessment or interpretation of study endpoints, such as trauma, severe blepharitis, keratitis, corneal ulcer, glaucoma, uveitis, or active ocular infection, etc.
  • 1. Ophthalmic exclusion criteria in ANY EYES Participant having experienced or experiencing at screening or randomisation visit: 1.4. History of Herpes Simplex Keratitis varicella-zoster.
  • 1. Ophthalmic exclusion criteria in ANY EYES Participant having experienced or experiencing at screening or randomisation visit: 1.5. Any ocular diseases other than VKC that would require topical ocular treatment during the study.
  • 2. Systemic/Non-ophthalmic exclusion criteria Participant having experienced or experiencing at Screening or Randomisation: 2.1 Known or suspected hypersensitivity to one of the components of the Investigational Medicinal Product(s) or auxiliary treatments (e.g. rescue medication) or diagnostic agents used during the study (e.g., potential topical anaesthetic, fluorescein).
  • 2. Systemic/Non-ophthalmic exclusion criteria Participant having experienced or experiencing at Screening or Randomisation: 2.2 History of, or active relevant systemic condition incompatible with the study or likely to interfere with the study results or the participant safety according to investigator judgment.
  • 2. Systemic/Non-ophthalmic exclusion criteria Participant having experienced or experiencing at Screening or Randomisation: 2.3 Disease not stabilised within 30 days before the screening visit (e.g. diabetes with outof- range glycemia, thyroid malfunction, uncontrolled autoimmune disease, current systemic infection), or judged by the investigator to be incompatible with the study.
  • 2. Systemic/Non-ophthalmic exclusion criteria Participant having experienced or experiencing at Screening or Randomisation: 2.4 Presence or history of systemic allergy (e.g., allergic rhinitis, food allergy) judged as severe by the investigator.

The study team makes the final eligibility decision.

Where it's taking place

  • India

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, 0-17 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include India. Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.