A Study to Compare the Effectiveness and Safety of T1695 Versus Ciclosporin in Participants With Moderate to Severe Vernal Keratoconjunctivitis
Efficacy and Safety Assessment of T1695 Ophthalmic Suspension, Versus Ciclosporin Ophthalmic Emulsion, in Participants With Moderate to Severe Vernal Keratoconjunctivitis (VKC)
2 other identifiers
interventional
120
1 country
11
Brief Summary
The aim of the study is to Compare the Effectiveness and Safety of T1695 Versus Ciclosporin in Participants with Moderate to Severe Vernal Keratoconjunctivitis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2026
Shorter than P25 for phase_2
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2025
CompletedFirst Posted
Study publicly available on registry
September 12, 2025
CompletedStudy Start
First participant enrolled
March 24, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 21, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 21, 2027
April 22, 2026
April 1, 2026
10 months
September 5, 2025
April 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline (Day 1) at Day 29 (Week 4) in Corneal Fluorescein Staining (CFS) grade assessed by the (0-5) modified Oxford scale in the study eye.
From Day 1 to Day 29
Study Arms (2)
T1695
EXPERIMENTALThe participant should instill T1695.
Ciclosporin
ACTIVE COMPARATORThe participant should instill Ciclosporin.
Interventions
The participant will have a slit lamp examination
The participant 's BCVA will be evaluated.
One drop of fluorescein will be instilled to assess the fluorescein staining score on the modified Oxford scale.
Eligibility Criteria
You may qualify if:
- Informed consent signed and dated
- 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.
You may not qualify if:
- Participants must not have any conditions which might exclude them from participating, could interfere with the study, or pose an unacceptable risk to their health.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Disha Eye Hospitals - Barrackpore
Kolkata, West Bengal, India
M&J Institute of Ophthalmology
Ahmedabad, India
Netralaya Super Speciality Eye Hospital
Ahmedabad, India
Narayana Nethralaya
Bangalore, India
L. V. Prasad Eye Institute (LVPEI)
Hyderabad, India
Agrawal Hospital
Jaipur, India
Regional Institute of Ophthalmology (RIO) - Kolkata
Kolkata, India
Regional Institute of Ophthalmology, Patna
Patna, India
PBMA'S H. V. Desai Eye Hospital
Pune, India
Shivam Retina Clinic and Eye Hospital
Surat, India
L V Prasad Eye Institute
Visakhapatnam, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2025
First Posted
September 12, 2025
Study Start
March 24, 2026
Primary Completion (Estimated)
January 21, 2027
Study Completion (Estimated)
January 21, 2027
Last Updated
April 22, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share