Phase 3 N=105 Randomized Single-blind Treatment

Efficacy and Safety of T2762 and Vismed® in Dry Eye Syndrome

Dry Eye Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT02023268 ↗

Enrolled (actual)

105

Serious AEs

0.0%

Results posted

Apr 2016

Primary outcome: Primary: Global Ocular Staining (With Oxford Scale - Ranges : 0-15) — -2.5; -2.7 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: T2762 (Device); Vismed® (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Laboratoires Thea
Primary completion: Dec 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Global Ocular Staining (With Oxford Scale - Ranges : 0-15)	-2.5; -2.7	—

Summary

Comparison of the efficacy and safety of T2762 and Vismed® in the treatment of moderate to severe Dry Eye Syndrome

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02023268). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.