| CTRI Number |
CTRI/2026/02/104277 [Registered on: 19/02/2026] Trial Registered Prospectively |
| Last Modified On: |
21/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Safety and Efficacy of ophthalmic suspension (T1695 versus Ciclosporin), in participants with moderate to severe Vernal Keratoconjunctivitis (VKC). |
|
Scientific Title of Study
|
Efficacy and safety assessment of T1695 ophthalmic suspension, versus Ciclosporin opthalmic emulsion, in participants with moderate to severe Vernal Keratoconjunctivitis (VKC) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2025-521567-12-00 |
EudraCT |
| LT1695-201 Version 3 dated 15May2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vishal Agrawal |
| Designation |
Principal Investigator |
| Affiliation |
Agrawal Hospital |
| Address |
Basement, Research room, Sp-3, Malviya Nagar Industrail Area,
Malviya Nagar Jaipur -302017 Rajasthan India
Jaipur
RAJASTHAN
302017
India |
| Phone |
9887870552 |
| Fax |
|
| Email |
drvishalsms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sumit Gupta |
| Designation |
Director, Clinical Operations |
| Affiliation |
Syneos Health India private Limited |
| Address |
4th Floor, Block 2, DLF Downtown, DLF City Phase 3 Rd, Ambience Island, DLF Phase 3, Sector 24, Gurugram, Haryana -122022
Gurgaon
HARYANA
122022
India |
| Phone |
9560453771 |
| Fax |
|
| Email |
sumit.gupta@syneoshealth.com |
|
Details of Contact Person
Public Query
|
| Name |
Ataur Rahman |
| Designation |
Manager, Clinical Operations |
| Affiliation |
Syneos Health India private Limited |
| Address |
4th Floor, Block 2, DLF Downtown, DLF City Phase 3 Rd, Ambience Island, DLF Phase 3, Sector 24, Gurugram, Haryana -122022
Gurgaon
HARYANA
122022
India |
| Phone |
8532011805 |
| Fax |
|
| Email |
ataur.rahman@syneoshealth.com |
|
|
Source of Monetary or Material Support
|
| Laboratoires THEA
12, rue Louis Blériot
63017 Clermont-Ferrand Cedex 2, France
|
|
|
Primary Sponsor
|
| Name |
Laboratoires THEA |
| Address |
12, rue Louis Blériot
63017 Clermont-Ferrand Cedex 2, France
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Ms Syneos Health India Pvt Ltd |
4th Floor Block-2, DLF Downtown, Commercial Site,
Block-V, DLF City, Phase III Sector 25A,
Gurugram, DLF QE Gurugram (India) – 122002 |
|
|
Countries of Recruitment
|
France
Bulgaria
Greece
India
Italy
Spain |
|
Sites of Study
|
| No of Sites = 11 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vishal Agrawal |
Agrawal Hospital |
Sp-3, Malviya Nagar Industrail Area, Malviya Nagar Jaipur -302017 Rajasthan India
Jaipur
RAJASTHAN |
9887870552
drvishalsms@gmail.com |
| Dr Samar Kumar Basak |
Disha Eye Hospitals Pvt.Ltd |
88(63A) Ghoshpara road Barrackpore, Kolkata-700120 WB, India
Kolkata
WEST BENGAL |
033-6636-0000
basak_sk@hotmail.com |
| Dr Sunita chaurasia |
L V Prasad Eye Institute |
Suven Clinical Research Department, 2nd Floor, Room no 206, GPR building, Road No.2 Banjara Hills, L V Prasad Marg, Hyderabad 500034, India.
Hyderabad
TELANGANA |
040-68102123
sunita@lvpei.org |
| Dr Srikant Kumar Sahu |
L V Prasad Eye Institute |
MTC Campus, Patia, Bhubaneswar, Pin- 751024, Odisha, India
Khordha
ORISSA |
9439488888
srikantsahu@lvpei.org |
| Dr Somesh Aggarwal |
M & J Western Regional Institute of Ophthalmology |
Room no 116,1st Floor, Retina Department, Asarwa, Ahmedabad-360016, Gujarat, India
Ahmadabad
GUJARAT |
9427029044
dr.somesh@yahoo.com |
| Dr Gairik Kundu |
Narayana Nethralaya |
121/C chord road, Rajajinagar,1st R block Bangalore 560010, India
Bangalore
KARNATAKA |
9986768469
k.gairik@gmail.com |
| Dr Parth Rana |
Netralaya Super Speciality Eye Hospital |
1st Floor, Kay DEE House, Above Union Bank, Parimal Garden Cross Road, Chimanlal Girdharlal Rd, Ambawadi, Ahmedabad - 380006, Gujarat, India
Ahmadabad
GUJARAT |
9727450700
netralaya.rch@gmail.com |
| Dr Shilpa Dike |
PBMAs H. V. Desai Eye Hospital |
Room no 339,2nd Floor, Dharamsey Nency Building,Cornea Department, 93 Tarawade Vasti, Mohammadwadi Hadapsar, Pune-411060
Pune
MAHARASHTRA |
020-26974000
drshilpajoshi@hvdeh.org |
| Dr Bibhuti Prassan Sinha |
Regional Institute Of Ophthalmology |
3rd Floor, Room no 313, IGIMS, Sheikhpura, Patna, Bihar-800014
Patna
BIHAR |
9470017777
bibhuti13@gmail.com |
| Dr Lakshmi Kanta Mondal |
Regional Institute of Ophthalmology |
88, College Street, Medical, College and Hospital, Kolkata-700073
Kolkata
WEST BENGAL |
9830830216
lakshmi.mondal62@gmail.com |
| Dr Shobhana Mange |
Shivam Retina Clinic and Eye Hospital |
HG-1 A, ITC Building, Majura Gate, Ring Road, Surat-395001, Gujarat, India.
Surat
GUJARAT |
9979530073
drshobhanamange@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 11 |
| Name of Committee |
Approval Status |
| Disha Eye Hospitals Pvt.Ltd Ethics Committee |
Approved |
| Ethics Committee L V Prasad Eye Institute |
Approved |
| Institutional Ethics Committee - B. J. Medical College and Civil Hospital |
Submittted/Under Review |
| Institutional Ethics Committee PBMAs H V Desai Eye Hospital |
Approved |
| Institutional Ethics Committee, IGIMS |
Approved |
| Institutional Ethics Committee, L V Prasad Eye Institute |
Approved |
| Institutional Ethics Committee. |
Approved |
| Narayana Nethralaya Ethics committee |
Approved |
| Somani Hospital Ethics Committee |
Approved |
| Swarnim Ethics Committee |
Approved |
| Unity Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H162||Keratoconjunctivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ciclosporin 0.1 percentage ophthalmic emulsion |
36 Weeks |
| Intervention |
T1695 0.1% ophthalmic suspension |
36 Weeks |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
Ophthalmic Exclusion Criteria, in any eyes
2.1.1. 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.
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 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. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
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. |
36 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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. |
4 to 5 Months |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="44"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/03/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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). |