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

NCT06375499 — Not applicable, Completed, 74 participants, Laboratoires Thea

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

Registry	NCT06375499
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	74 (Actual)
Sponsor	Laboratoires Thea (Industry)
Conditions	Dry Eye Syndrome
Interventions	T2769, Hylo-Forte® (Device)
Dates	start 2024-09-17, primary completion 2025-01-06, completion 2025-01-06, first posted 2024-04-19, last updated 2026-01-02
Locations	4 sites in Czechia, Hungary

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
T2769	Experimental	Device: T2769	Hyaluronic acid, Trehalose, Naaga Route of administration: topical, ocular use
Hylo-Forte®	Active comparator	Device: Hylo-Forte®	Hyaluronic acid Route of administration: topical, ocular use

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

+Outcome measures

Primary outcomes

To Demonstrate the Non-inferiority of T2769 Compared to Hylo-Forte® in Terms of Total Ocular Surface Staining (Oxford Score). [Oxford 0-15 grading scheme: is assessed at Day 1, Day 15 and Day 36]: 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)

+Eligibility

Sex: All, ages: 18 Years to any

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

+Posted results

Participant flow

Milestone	T2769	Hylo-Forte
Started	36	38
Completed	35	38
Not completed	1	0

Outcome results

To Demonstrate the Non-inferiority of T2769 Compared to Hylo-Forte® in Terms of Total Ocular Surface Staining (Oxford Score). (Primary), Least squares mean, score on a scale: T2769 -1.3 (-2.0 to -0.5); Hylo-Forte -1.2 (-1.9 to -0.5)

Adverse events

Time frame: 7 weeks from D-10 to D36 (+3 days)

Arm	Deaths	Serious adverse events	Other adverse events
T2769	0/36 (0.0%)	0/36 (0.0%)	0/36 (0.0%)
Hylo-Forte	0/38 (0.0%)	0/38 (0.0%)	0/38 (0.0%)

+Locations (4)

Facility	City	Country
OFTEX, s.r.o.	Prague	Czechia
Axon Clinical, s.r.o.	Prague	Czechia
Ganglion Medical Center	Pécs, Baranya	Hungary
Ermellek Egeszsegcentrum	Létavértes, Hb	Hungary

+Study documents

Study Protocol (PDF, 2024-04-09)
Statistical Analysis Plan (PDF, 2025-02-07)