RecruitingPhase 2NCT07169695

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)


Sponsor

Laboratoires Thea

Enrollment

120 participants

Start Date

Mar 24, 2026

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 4 YearsMax Age: 17 Years

Inclusion Criteria3

  • 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.

Exclusion Criteria1

  • 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.

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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.

DRUGCiclosporin

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.


Locations(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

View Full Details on ClinicalTrials.gov

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NCT07169695