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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521567-12-00 | EU Trial (CTIS) Number |
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The aim of the study is to Compare the Effectiveness and Safety of T1695 Versus Ciclosporin in Participants with Moderate to Severe Vernal Keratoconjunctivitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T1695 | Experimental | The participant should instill T1695. |
|
| Ciclosporin | Active Comparator | The participant should instill Ciclosporin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Slit Lamp Examination | Diagnostic Test | The participant will have a slit lamp examination |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From Day 1 to Day 29 |
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Main Inclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Corentin LE CAMUS | Contact | +33473981436 | Corentin.LECAMUS@theapharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Disha Eye Hospitals - Barrackpore | Recruiting | Kolkata | West Bengal | India | ||
| M&J Institute of Ophthalmology |
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| Far Best Corrected Visual Acuity (BCVA) | Diagnostic Test | The participant 's BCVA will be evaluated. |
|
| T1695 | Drug | The participant should instill T1695. |
|
| Ciclosporin | Drug | The participant should instill Ciclosporin. |
|
| Corneal fluorescein staining score on modified Oxford scale | Diagnostic Test | One drop of fluorescein will be instilled to assess the fluorescein staining score on the modified Oxford scale. |
|
| Recruiting |
| Ahmedabad |
| India |
| Netralaya Super Speciality Eye Hospital | Recruiting | Ahmedabad | India |
| Narayana Nethralaya | Recruiting | Bangalore | India |
| L. V. Prasad Eye Institute (LVPEI) | Recruiting | Hyderabad | India |
| Agrawal Hospital | Recruiting | Jaipur | India |
| Regional Institute of Ophthalmology (RIO) - Kolkata | Recruiting | Kolkata | India |
| Regional Institute of Ophthalmology, Patna | Recruiting | Patna | India |
| PBMA'S H. V. Desai Eye Hospital | Recruiting | Pune | India |
| Shivam Retina Clinic and Eye Hospital | Recruiting | Surat | India |
| L V Prasad Eye Institute | Recruiting | Visakhapatnam | India |
| ID | Term |
|---|---|
| D003233 | Conjunctivitis, Allergic |
| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000072776 | Slit Lamp Microscopy |
| D016572 | Cyclosporine |
| ID | Term |
|---|---|
| D003941 | Diagnostic Techniques, Ophthalmological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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