Comparison of the Efficacy and Safety of T2750 and Vismed® in the Treatment of Moderate to Severe Dry Eye Syndrome

NCT01568593 | Completed Phase 3 Results

• 1 other identifier: LT2750-PIII-10/11
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

Comparison of the efficacy and safety of T2750 and Vismed® in the treatment of moderate to severe Dry Eye Syndrome

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

• Global Ocular Staining (With Oxford Scale - Ranges :0-15)

  Change from baseline in the worse eye on Day 35 (decrease of Oxford score = better outcome)

  Baseline and 35 days

Study Arms (2)

T2750

EXPERIMENTAL

Device: T2750

Vismed

ACTIVE COMPARATOR

Device: Vismed

Interventions

T2750 DEVICE

1 drop in each eye 3 to 6 times daily during 84 days

T2750

Vismed DEVICE

1 drop in each eye 3 to 6 times daily during 84 days

Vismed

Eligibility Criteria

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

You may qualify if:

• Signed and dated informed consent
• Male or female aged from ≥ 18 years old.
• Known Dry Eye Syndrome requiring artificial tears within the last 3 months prior to study selection.

You may not qualify if:

• Best far corrected visual acuity \< 1/10
• Severe blepharitis
• Severe Dry Eye
• Eyelid malposition
• Known hypersensitivity to one of the components of the study medications or test products.
• Pregnant or breast-feeding woman.
• Woman of childbearing age (neither menopausal, nor hysterectomised, nor sterilized) not using effective contraception (oral contraceptives, intra-uterine device, contraceptive implant or condoms).
• Inability of patient to understand the study procedures and thus inability to give informed consent.
• Non compliant patient (e.g. not willing to attend the follow-up visits, way of life interfering with compliance).
• Already included once in this study.
• Patient under guardianship.

Sponsors & Collaborators

• Laboratoires Thea: lead

Study Sites (1)

Unknown Facility

Paris, France

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Dr Pascale POULIQUEN
• Organization: Laboratoires Thea

p.pouliquen@laboratoires-thea.fr

0473981436

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2012
• First Posted: April 2, 2012
• Study Start: March 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: April 4, 2016
• Results First Posted: October 27, 2014

Record last verified: 2014-10

Locations

FR (1)