T1695 versus ciclosporin for moderate to severe vernal keratoconjunctivitis in children and teenagers
Efficacy and Safety Assessment of T1695 Ophthalmic Suspension, Versus Ciclosporin Ophthalmic Emulsion, in Participants With Moderate to Severe Vernal Keratoconjunctivitis (VKC)
This study will test whether T1695 eye treatment works better and is as safe as ciclosporin for kids and teens (ages 4–17) with moderate to severe vernal keratoconjunctivitis.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 4 Years to 17 Years |
| Sex | All |
| Sponsor | Laboratoires Thea Industry-sponsored |
| Locations | 11 sites (Kolkata, West Bengal and 10 other locations) |
| Trial ID | NCT07169695 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional trial compares T1695 with ciclosporin in children and adolescents (ages 4 to less than 18) who have moderate to severe vernal keratoconjunctivitis. Participants will be assigned to receive either T1695 or ciclosporin eye treatment and followed with slit-lamp examinations, best-corrected visual acuity testing, corneal fluorescein staining using a modified Oxford scale, and Bonini grading of disease severity. Safety and effectiveness outcomes will be compared between groups over the study period to see if T1695 controls inflammation and symptoms as well as or better than ciclosporin. The trial is being conducted at specialized eye hospitals in India and requires informed consent from participants and guardians.
Who should consider this trial
Good fit: Children and adolescents aged 4 to less than 18 years with bilateral Bonini grade 3 or 4 vernal keratoconjunctivitis and parental/guardian consent would be eligible candidates.
Not a fit: Patients with mild VKC, adults, or those with other ocular conditions or protocol exclusions are unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, T1695 could provide better symptom control or fewer side effects than ciclosporin for children with moderate to severe VKC.
How similar studies have performed: Topical ciclosporin has established benefit in VKC, while T1695 is a novel agent with limited published clinical data and is being tested directly against ciclosporin.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Kolkata, West Bengal and 10 other locations
- 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)
Study contacts
- Study coordinator: Corentin LE CAMUS
- Email: Corentin.LECAMUS@theapharma.com
- Phone: +33473981436
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.