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

Dry Eye Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01568593
• Other study ID #: LT2750-PIII-10/11
• Status: Completed
• Phase: Phase 3
• First received: March 29, 2012
• Last updated: October 24, 2014
• Start date: March 2012
• Est. completion date: March 2013

Study information

• Verified date: October 2014
• Source: Laboratoires Thea
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Syndrome

Intervention

Device:
• T2750
1 drop in each eye 3 to 6 times daily during 84 days
• Vismed
1 drop in each eye 3 to 6 times daily during 84 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoires Thea

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	35 days	No