CTRI/2026/02/0104277尚未招募2 期
Efficacy and safety assessment of T1695 ophthalmic suspension, versus Ciclosporin opthalmic emulsion, in participants with moderate to severe Vernal Keratoconjunctivitis (VKC)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 11
- 主要终点
- evolution of keratitis in
研究概览
简要总结
This is a phase II, multicenter, randomized, investigator-masked, 2 parallel-group controlled, 3-month
treatment (Period 1) followed by a 3-month follow-up period (Period 2).
In this study 120 participants will be randomized.
The study duration will be maximum of 9 months, divided in 3parts:
A 3-month wash-out period (Wash-Out Period).
A 3-month efficacy and safety evaluation treatment period (Period 1).
Followed by a 3-month follow-up period (Period 2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Participant fulfilling all of the following criteria will be eligible: 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.
- •Male or female participant from 4 years to less than 18 years old.
- •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.
- •and/or 1.4.2 who is currently.
- •Refractory to anti-allergic agents or b.
- •Cortico-dependent or c.
- •Resistant or insufficiently responsive to ophthalmic ciclosporin.
- •Participant requiring therapy for moderate to severe VKC and for whom there is no contraindication to treatment with ciclosporin and tacrolimus.
- •Participant able to safely discontinue the use of VKC medication (if any) for the specified washout period, according to the investigator’s judgment.
- •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.
- •Grading score of 3 or 4 on the Bonini scale for clinical grading of VKC in each eye.
- •Severe keratitis defined as 4 or 5 on the (0-5) modified Oxford corneal fluorescein staining score in each eye.
- •Visual Analog Scales (0-100mm VAS) of VKC symptoms (among photophobia, tearing, itching, and mucous discharge) of greater than 60 mm in each eye.
- •Participant with a Quality of Life in children with VKC (16-48 QUICK) questionnaire score from 32 to 48.
排除标准
- •Ophthalmic Exclusion Criteria, in any eyes 2.1.
- •Naïve 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.
- •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.
- •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.
- •History of Herpes Simplex Keratitis varicella-zoster.
- •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).
- •Exclusion Criteria Related to General Conditions 2.4 2.4.
- •History of drug or psychotropic substances consumption; drug or psychotropic substances abuse or any addiction.
- •History of drug addiction or alcohol abuse according to the Investigator’s judgement.
- •Inability of participant and/or relatives to understand the study procedures or to give informed consent.
- •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).
- •Participation in this study at the same time as another clinical study.
- •Participant previously randomised in this study.
- •Exclusion criteria related to previous and concomitant treatments (medications/non- medicinal therapies/procedures) 2.5 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 following table.
结局指标
主要结局
evolution of keratitis in
时间窗: 36 Weeks
participants with moderate to
时间窗: 36 Weeks
severe VKC.
时间窗: 36 Weeks
To compare the efficacy of
时间窗: 36 Weeks
T1695 0.1% ophthalmic
时间窗: 36 Weeks
suspension twice a day (BID)
时间窗: 36 Weeks
versus Ciclosporin 0.1%
时间窗: 36 Weeks
ophthalmic emulsion four times
时间窗: 36 Weeks
a day (QID) at D29 on the
时间窗: 36 Weeks
次要结局
- To evaluate the safety and(tolerability of T1695 0.1%)
研究者
Dr Vishal Agrawal
Agrawal Hospital
研究点 (11)
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