Health Condition 1: H162- Keratoconjunctivitis
Conditions
Sponsors
Laboratoires THEA
Ms Syneos Health India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Participant fulfilling all of the following criteria will be eligible: 1.1. Informed consent signed and dated. Obtained from the participant (if the participant is able to understand and sign it) and his or her legally acceptable relatives (mother or father, or tutor or witness) according to regional laws and regulations prior to the initiation of any procedure. At the Screening visit. 1.2. Male or female participant from 4 years to less than 18 years old. 1.3. 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. 1.4. Participant- 1.4.1 who experienced at least 1 relapse of active VKC in the past year prior to enrolment. and/or 1.4.2 who is currently. a. Refractory to anti-allergic agents or b. Cortico-dependent or c. Resistant or insufficiently responsive to ophthalmic ciclosporin. 1.5. Participant requiring therapy for moderate to severe VKC and for whom there is no contraindication to treatment with ciclosporin and tacrolimus. 1.6. Participant able to safely discontinue the use of VKC medication (if any) for the specified washout period, according to the investigator s judgment. 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. 1.8. Grading score of 3 or 4 on the Bonini scale for clinical grading of VKC in each eye. 1.9. Severe keratitis defined as 4 or 5 on the (0-5) modified Oxford corneal fluorescein staining score in each eye. 1.10. Visual Analog Scales (0-100mm VAS) of VKC symptoms (among photophobia, tearing, itching, and mucous discharge) of greater than 60 mm in each eye. 1.11. Participant with a Quality of Life in children with VKC (16-48 QUICK) questionnaire score from 32 to 48.
Exclusion criteria
Exclusion criteria: Ophthalmic Exclusion Criteria, in any eyes 2.1.1. Na ve participant (patient who did not receive any VKC treatment prior to enrolment) with moderate VKC defined as less then 3 on the Bonini scale for clinical grading of VKC. 2.1.2. Any type of ocular surgery, including eye lid interventions within 6 months before the randomisation visit. Participant experiencing at screening and randomisation visit or having experienced: 2.1.3. Any relevant pre-existing eye condition other that VKC preventing accurate assessment or interfering with the interpretation of study endpoints, including trauma, post radiation keratitis, severe blepharitis, rosacea, corneal ulcer, corneal neovascularization, uveitis, glaucoma, lid anatomic features, abnormalities of the nasolacrimal drainage system or blinking function, active ocular infection, etc. 2.1.4. History of Herpes Simplex Keratitis varicella-zoster. 2.1.5. Any ocular diseases other than VKC that would require topical ocular treatment during the study. Systemic or non-Ophthalmic Exclusion Criteria 2.2 Participant having experienced or experiencing at screening and randomisation: 2.2.1 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). 2.2.2 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. 2.2.3 Disease not stabilised within 30 days before the screening visit (e.g. diabetes with out of-range glycemia, thyroid malfunction, uncontrolled autoimmune disease, current systemic infection), or judged by the investigator to be incompatible with the study. 2.2.4 Presence or history of systemic allergy (e.g., allergic rhinitis, food allergy) judged as severe by the investigator. 2.2.5 Participants with untreated asthma judged as severe by the investigator based on participant s medical history. 2.2.6 History of malignancy within the last 5 years. Specific Exclusion Criteria Regarding Childbearing Potential Women 2.3 2.3.1 Pregnancy for post menarche participant (confirmed with a positive urine pregnancy test). 2.3.2. Male/female of childbearing potential who is sexually active and is not willing to use preventive measures. Exclusion Criteria Related to General Conditions 2.4 2.4.1. History of drug or psychotropic substances consumption; drug or psychotropic substances abuse or any addiction. 2.4.2. History of drug addiction or alcohol abuse according to the Investigator s judgement. 2.4.3. Inability of participant and/or relatives to understand the study procedures or to give informed consent. 2.4.4. Non-compliant participant and/or relatives (e.g., not willing to attend a visit or completing the self-questionnaire). 2.4.5. 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). 2.4.6. Participation in this study at the same time as another clinical study. 2.4.7. Participant previously randomised in this study. Exclusion criteria related to previous and concomitant trea
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.Timepoint: 36 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of T1695 0.1% ophthalmic suspension BID versus Ciclosporin 0.1% ophthalmic emulsion QID in moderate to severe VKC per period (for Period 2, only in responder participants at D85). To evaluate the safety and tolerability of T1695 0.1% ophthalmic suspension BID versus Ciclosporin 0.1% ophthalmic emulsion QID in moderate to severe VKC in the follow-up period (Period 2) in non-responder participants at D85.Timepoint: 4 to 5 Months | — |
Countries
Bulgaria, France, Greece, India, Italy, Spain
Contacts
Public ContactAtaur Rahman
Syneos Health India private Limited
Outcome results
None listed