Moderate to Severe Vernal KeratoconjunctivitisPhase 2NCT07169695
A Study to Compare the Effectiveness and Safety of T1695 Versus Ciclosporin in Participants With Moderate to Severe Vernal Keratoconjunctivitis
A Phase 2 study testing Slit Lamp Examination, Far Best Corrected Visual Acuity (BCVA) and T1695 in people with Moderate to Severe Vernal Keratoconjunctivitis, run by Laboratoires Thea at 11 sites in India.
Trial 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 Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Moderate to Severe Vernal Keratoconjunctivitis
- What is being tested?
- Slit Lamp Examination, Far Best Corrected Visual Acuity (BCVA) and T1695
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 11 sitesIndia
- Study dates
- 24 Mar 2026to 21 Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
India11 sites, 11 recruiting
- Recruiting
M&J Institute of Ophthalmology
Ahmedabad
- Recruiting
Netralaya Super Speciality Eye Hospital
Ahmedabad
- Recruiting
Narayana Nethralaya
Bangalore
- Recruiting
L. V. Prasad Eye Institute (LVPEI)
Hyderabad
- Recruiting
Agrawal Hospital
Jaipur
- Recruiting
Disha Eye Hospitals - Barrackpore
Kolkata, West Bengal
- Recruiting
Regional Institute of Ophthalmology (RIO) - Kolkata
Kolkata
- Recruiting
Regional Institute of Ophthalmology, Patna
Patna
- Recruiting
PBMA'S H. V. Desai Eye Hospital
Pune
- Recruiting
Shivam Retina Clinic and Eye Hospital
Surat
- Recruiting
L V Prasad Eye Institute
Visakhapatnam
About this study
Official title: Efficacy and Safety Assessment of T1695 Ophthalmic Suspension, Versus Ciclosporin Ophthalmic Emulsion, in Participants With Moderate to Severe Vernal Keratoconjunctivitis (VKC)
The aim of the study is to Compare the Effectiveness and Safety of T1695 Versus Ciclosporin in Participants with Moderate to Severe Vernal Keratoconjunctivitis
- Being tested
- Slit Lamp Examination, Far Best Corrected Visual Acuity (BCVA), T1695, Ciclosporin, Corneal fluorescein staining score on modified Oxford scale
- Keywords
- Vernal Keratoconjunctivitis
- Medical subject headings
- Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slit Lamp ExaminationDiagnostic test
The participant will have a slit lamp examination
Far Best Corrected Visual Acuity (BCVA)Diagnostic test
The participant 's BCVA will be evaluated.
T1695Drug
The participant should instill T1695.
CiclosporinDrug
The participant should instill Ciclosporin.
Corneal fluorescein staining score on modified Oxford scaleDiagnostic test
One drop of fluorescein will be instilled to assess the fluorescein staining score on the modified Oxford scale.
| Study group | Role | What they receive |
|---|---|---|
| T1695 | Experimental | The participant should instill T1695. Receives: Diagnostic Test: Slit Lamp Examination; Diagnostic Test: Far Best Corrected Visual Acuity (BCVA); Drug: T1695; Diagnostic Test: Corneal fluorescein staining score on modified Oxford scale |
| Ciclosporin | Active comparator | The participant should instill Ciclosporin. Receives: Diagnostic Test: Slit Lamp Examination; Diagnostic Test: Far Best Corrected Visual Acuity (BCVA); Drug: Ciclosporin; Diagnostic Test: Corneal fluorescein staining score on modified Oxford scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Day 1 to Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start24 Mar 2026
- Primary completion21 Jan 2027 (estimated)
- Study completion21 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Vernal KeratoconjunctivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratoires Thea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07169695
- Sponsor's protocol ID
- LT1695-201
- Other IDs
- 2025-521567-12-00, 2025
- Status last verified
- Apr 2026
- First submitted
- 5 Sep 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Assessment of T1695 Ophthalmic Suspension, Versus Ciclosporin Ophthalmic Emulsion, in Participants With Moderate to Severe Vernal Keratoconjunctivitis (VKC)
- ClinicalTrials.gov ID
- NCT07169695
- Acronym / sponsor ID
- LT1695-201
- Keywords
- Vernal Keratoconjunctivitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Laboratoires TheaIndustry (pharma, biotech, devices)
- Study start
- 24 Mar 2026 (actual)
- Primary completion
- 21 Jan 2027 (estimated)
- Study completion
- 21 Jan 2027 (estimated)
- First posted
- 12 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to Compare the Effectiveness and Safety of T1695 Versus Ciclosporin in Participants with Moderate to Severe Vernal Keratoconjunctivitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T1695 | Experimental | Diagnostic Test: Slit Lamp Examination, Diagnostic Test: Far Best Corrected Visual Acuity (BCVA), Drug: T1695, Diagnostic Test: Corneal fluorescein staining score on modified Oxford scaleThe participant should instill T1695. |
| Ciclosporin | Active comparator | Diagnostic Test: Slit Lamp Examination, Diagnostic Test: Far Best Corrected Visual Acuity (BCVA), Drug: Ciclosporin, Diagnostic Test: Corneal fluorescein staining score on modified Oxford scaleThe participant should instill Ciclosporin. |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Slit Lamp ExaminationThe participant will have a slit lamp examination | Diagnostic test | Ciclosporin, T1695 |
| Far Best Corrected Visual Acuity (BCVA)The participant 's BCVA will be evaluated. | Diagnostic test | Ciclosporin, T1695 |
| T1695The participant should instill T1695. | Drug | T1695 |
| CiclosporinThe participant should instill Ciclosporin. | Drug | Ciclosporin |
| Corneal fluorescein staining score on modified Oxford scaleOne drop of fluorescein will be instilled to assess the fluorescein staining score on the modified Oxford scale. | Diagnostic test | Ciclosporin, T1695 |
Primary outcome
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.
Time frame: From Day 1 to Day 29
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Moderate to Severe Vernal Keratoconjunctivitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Slit Lamp Examination, Far Best Corrected Visual Acuity (BCVA) and T1695 in people with Moderate to Severe Vernal Keratoconjunctivitis, run by Laboratoires Thea at 11 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Corentin LE CAMUS (+33473981436, Corentin.LECAMUS@theapharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: From Day 1 to Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.