Clincosm LogoSign in Get a demo

Comparison of the Performance and Safety of T2769 Versus Vismed® Multi in the Treatment of Moderate to Severe Dry Eye Syndrome

Sponsor
Laboratoires Thea (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05965778
Collaborator
(none)
226
Enrollment
2
Arms
11
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

To demonstrate the non-inferiority of T2769 compared to Vismed® Multi in terms of total ocular surface staining (Oxford score) after 35 days of treatment.

To evaluate the performance and safety of T2769 versus Vismed® Multi.

Condition or Disease Intervention/Treatment Phase
  • Device: T2769
  • Device: Vismed® Multi
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
226 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Comparison of the Performance and Safety of T2769 Versus Vismed® Multi in the Treatment of Moderate to Severe Dry Eye Syndrome
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: T2769

Device: T2769
T2769: sodium hyaluronate, Trehalose, Naaga in a 12.5 mL ABAK® multi-dose bottle.
Active Comparator: Vismed® Multi

Device: Vismed® Multi
Hyaluronic acid

Outcome Measures

Primary Outcome Measures

  1. Change from baseline (Day 1) in total ocular surface staining grade according to Oxford 0-15 grading scheme. [Oxford 0-15 grading scheme: is assessed at Day 1 and Day 36]

    The primary endpoint is the change from baseline (Day 1) in total ocular surface staining grade according to Oxford 0-15 grading scheme at D36 in the study eye.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Informed consent signed and dated (obtained prior to initiating any procedures).

  • Patient aged ≥18 years old.

  • Known dry eye syndrome requiring artificial tears for at least the last 3 months prior to screening visit.

  • Surface Disease Index (OSDI) Score ≥ 23.

  • Ocular discomfort evaluated by VAS ≥ 40 mm.

Exclusion Criteria:

  • Far best-corrected visual acuity (BCVA) ≥+0.7 LogMar (e.g., ≤0.2 in decimal value or ≤20/100 Snellen equivalent or ≤50 (ETDRS) letters Early Treatment Diabetic Retinopathy Study).

  • Severe blepharitis according to the judgment of the investigator

  • Dry eye associated with at least one of the following diseases/symptoms: ocular rosacea, Pterygium, Eyelid malposition, Corneal dystrophy, Ocular neoplasia, Filamentous keratitis, Corneal neovascularisation, Orbital radiotherapy, Cataract, Retinal disease.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Laboratoires Thea

Investigators

  • Principal Investigator: Frédéric CHIAMBARETTA, Prof., Individual Practice for Specialized Ophthalmology Care

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Laboratoires Thea
ClinicalTrials.gov Identifier:
NCT05965778
Other Study ID Numbers:
  • LT2769-002
First Posted:
Jul 28, 2023
Last Update Posted:
Jul 28, 2023
Last Verified:
Jul 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca

Study Results

No Results Posted as of Jul 28, 2023