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NCT06375499 Clinical Trial

Comparison of the Performance and Safety of T2769 Versus Hylo-Forte® in the Treatment of Moderate to Severe Dry Eye Syndrome.

Dry Eye Syndrome Clinical Trial

Official title:
Comparison of the Performance and Safety of T2769 Versus Hylo-Forte® in the Treatment of Moderate to Severe Dry Eye Syndrome.

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06375499
Other study ID # LT2769-004
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 1, 2024
Est. completion date April 28, 2025

Study information
Verified date March 2024
Source Laboratoires Thea
Contact Corentin LE CAMUS
Phone +33473981436
Email Corentin.LECAMUS@theapharma.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective is to demonstrate the non-inferiority of T2769 compared to Hylo-Forte® in terms of the change from baseline (D1) in total ocular surface staining score assessed on Oxford 0-15 scale, in the study eye at the D36 visit. The investigation is defined as a post-market stage. The clinical investigation design is confirmatory.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 74
Est. completion date April 28, 2025
Est. primary completion date April 28, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Main Inclusion Criteria (At Screening visit): - Informed consent signed and dated (obtained prior to initiating any procedures). - Patient aged =18 years old. - Persistence of dry eye syndrome, despite artificial tears use in the previous month prior to the screening visit Main Exclusion Criteria (At both Screening and Randomisation visits): - Far Best-Corrected Visual Acuity (BCVA) =+0.7 LogMar (e.g., =0.2 in decimal value or =20/100 Snellen equivalent or =50 letters Early Treatment Diabetic Retinopathy Study (ETDRS)). - Patient with previous or current ophthalmic condition

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• T2769
Daily dose regimen: 1 drop in each eye, from 3 to 6 times daily.
• Hylo-Forte®
Daily dose regimen: 1 drop in each eye, from 3 to 6 times daily.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Laboratoires Thea

Outcome
Type Measure Description Time frame Safety issue
Primary To demonstrate the non-inferiority of T2769 compared to Hylo-Forte® in terms of total ocular surface staining (Oxford score). The primary endpoint is the change from baseline (Day 1) in total ocular surface staining grade according to Oxford Scale 0-15 grading scheme at D36 in the study eye. Minimum value is 0 (better case) and maximum value is 15 (worse case) Oxford 0-15 grading scheme: is assessed at Day 1, Day 15 and Day 36
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