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

NCT06375499 | Completed Results

• 1 other identifier: LT2769-004
• Study Type: interventional
• Target: 74
• Locations: 2 countries
• Sites: 4

Brief 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.

Conditions

Dry Eye Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

T2769

EXPERIMENTAL

Hyaluronic acid, Trehalose, Naaga Route of administration: topical, ocular use

Device: T2769

Hylo-Forte®

ACTIVE COMPARATOR

Hyaluronic acid Route of administration: topical, ocular use

Device: Hylo-Forte®

Interventions

T2769 DEVICE

Daily dose regimen: 1 drop in each eye, from 3 to 6 times daily.

T2769

Hylo-Forte® DEVICE

Daily dose regimen: 1 drop in each eye, from 3 to 6 times daily.

Hylo-Forte®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laboratoires Thea: lead

Study Sites (4)

OFTEX, s.r.o.

Prague, 11800, Czechia

Location

Axon Clinical, s.r.o.

Prague, 15000, Czechia

Location

Ganglion Medical Center

Pécs, Baranya, 7621, Hungary

Location

Ermellek Egeszsegcentrum

Létavértes, Hb, 4281, Hungary

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Corentin LE CAMUS
• Organization: Laboratoires Théa

Corentin.LECAMUS@theapharma.com

0033 473989604

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 19, 2024
• Study Start: September 17, 2024
• Primary Completion: January 6, 2025
• Study Completion: January 6, 2025
• Last Updated: January 2, 2026
• Results First Posted: January 2, 2026

Record last verified: 2025-12

Locations

HU (2); CZ (2)