T1695 versus ciclosporin for moderate to severe vernal keratoconjunctivitis in children and teenagers
Official title: Efficacy and Safety Assessment of T1695 Ophthalmic Suspension, Versus Ciclosporin Ophthalmic Emulsion, in Participants With Moderate to Severe Vernal Keratoconjunctivitis (VKC)
Run by Laboratoires Thea · NCT07169695 · Data updated 2026-11-12
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 |
| Ages | 4 Years to 17 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Laboratoires Thea Industry-sponsored |
| Locations | 11 sites (Kolkata, West Bengal and 10 other locations) |
| Status | Recruiting |
| Started | March 24, 2026 |
| Main results expected | January 21, 2027 |
| Study ends | January 21, 2027 |
| Registry record updated | April 22, 2026 |
| Trial ID | NCT07169695 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with mild VKC, adults, or those with other ocular conditions or protocol exclusions are unlikely to benefit from participating.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
Show 5 more locations
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
3% Diquafosol plus 0.1% cyclosporin for active moderate-to-severe vernal keratoconjunctivitis with keratitis
This trial will test whether adding 3% Diquafosol eye drops to 0.1% cyclosporin helps people aged 6 and older who have active moderate-to-severe vernal keratoconjunctivitis with corneal staining.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.