A Study to Compare the Effectiveness and Safety of T1695 Versus Ciclosporin in Participants With Moderate to Severe Vernal Keratoconjunctivitis
Phase 2 – studying effectiveness and dosage
Conditions:
Moderate to Severe Vernal Keratoconjunctivitis
Sponsor: Laboratoires Thea
trial.available_in:
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Overview
The aim of the study is to Compare the Effectiveness and Safety of T1695 Versus Ciclosporin in Participants with Moderate to Severe Vernal Keratoconjunctivitis
Who can participate
Main Inclusion Criteria:
* 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.
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.
Interventions
Slit Lamp Examination
DIAGNOSTIC_TEST
Far Best Corrected Visual Acuity (BCVA)
DIAGNOSTIC_TEST
T1695
DRUG
Ciclosporin
DRUG
Corneal fluorescein staining score on modified Oxford scale
DIAGNOSTIC_TEST
Locations
11
India (11)
M&J Institute of Ophthalmology
Ahmedabad
Netralaya Super Speciality Eye Hospital
Ahmedabad
Narayana Nethralaya
Bangalore
L. V. Prasad Eye Institute (LVPEI)
Hyderabad
Agrawal Hospital
Jaipur
Disha Eye Hospitals - Barrackpore
Kolkata , West Bengal
Regional Institute of Ophthalmology (RIO) - Kolkata
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