ClinicalTrials.gg
RecruitingNCT07169695Updated Apr 22, 2026

A Study to Compare the Effectiveness and Safety of T1695 Versus Ciclosporin in Participants With Moderate to Severe Vernal Keratoconjunctivitis

A Phase 2 interventional study of Slit Lamp Examination and Far Best Corrected Visual Acuity (BCVA) in Moderate to Severe Vernal Keratoconjunctivitis, sponsored by Laboratoires Thea. Recruiting at 11 sites in India. Open to participants aged 4 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-04-22.

Sponsored by Laboratoires Thea · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2026; still recruiting 7 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
4 Years to 17 Years
Sex
All
01

Study 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

02

Conditions studied

  • Moderate to Severe Vernal Keratoconjunctivitis

Keywords

  • Vernal Keratoconjunctivitis
03

In context

Conjunctivitis, Allergic

210 studies on the registry are indexed under Conjunctivitis, Allergic; 18 are open to participants now.

This study's planned enrollment of 120 is above the median of 87 across 174 interventional studies indexed under Conjunctivitis, Allergic.

Browse Conjunctivitis, Allergic studies →

Lead sponsor

Laboratoires Thea is the lead sponsor of 64 studies on the registry; 6 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Main Inclusion Criteria:

  • 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.

Main Exclusion Criteria:

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.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    T1695

    The participant should instill T1695.

    Diagnostic Test: Slit Lamp Examination · Diagnostic Test: Far Best Corrected Visual Acuity (BCVA) · Drug: T1695 · Diagnostic Test: Corneal fluorescein staining score on modified Oxford scale

  • Active comparator
    Ciclosporin

    The participant should instill Ciclosporin.

    Diagnostic Test: Slit Lamp Examination · Diagnostic Test: Far Best Corrected Visual Acuity (BCVA) · Drug: Ciclosporin · Diagnostic Test: Corneal fluorescein staining score on modified Oxford scale

Interventions

  • Diagnostic testSlit Lamp Examination

    The participant will have a slit lamp examination

  • Diagnostic testFar Best Corrected Visual Acuity (BCVA)

    The participant 's BCVA will be evaluated.

  • DrugT1695

    The participant should instill T1695.

  • The participant should instill Ciclosporin.

  • Diagnostic testCorneal fluorescein staining score on modified Oxford scale

    One drop of fluorescein will be instilled to assess the fluorescein staining score on the modified Oxford scale.

06

What researchers measure

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.

    Time frame: From Day 1 to Day 29

07

Study locations

11 of 11 sites recruiting
  • Disha Eye Hospitals - Barrackpore
    Kolkata, West Bengal, India
    Recruiting
  • M&J Institute of Ophthalmology
    Ahmedabad, India
    Recruiting
  • Netralaya Super Speciality Eye Hospital
    Ahmedabad, India
    Recruiting
  • Narayana Nethralaya
    Bangalore, India
    Recruiting
  • L. V. Prasad Eye Institute (LVPEI)
    Hyderabad, India
    Recruiting
  • Agrawal Hospital
    Jaipur, India
    Recruiting
  • Regional Institute of Ophthalmology (RIO) - Kolkata
    Kolkata, India
    Recruiting
  • Regional Institute of Ophthalmology, Patna
    Patna, India
    Recruiting
  • PBMA'S H. V. Desai Eye Hospital
    Pune, India
    Recruiting
  • Shivam Retina Clinic and Eye Hospital
    Surat, India
    Recruiting
  • L V Prasad Eye Institute
    Visakhapatnam, India
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07169695
Lead sponsor
Laboratoires Thea
Responsible party
Sponsor
First posted
Sep 12, 2025
Start date
Mar 24, 2026
Primary completion
Jan 21, 2027 (estimated)
Completion
Jan 21, 2027 (estimated)
Last update
Apr 22, 2026

Study contacts

Corentin LE CAMUS
Contact
Corentin.LECAMUS@theapharma.com
+33473981436

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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