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

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Thea Pharma

Status and phase

Completed
Phase 3

Conditions

Dry Eye Syndrome

Treatments

Device: Vismed®
Device: T2762

Study type

Interventional

Funder types

Industry

Identifiers

NCT02023268
2013-A01292-43 (Registry Identifier)
LT2762-PIII-08/13

Details and patient eligibility

About

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

Enrollment

105 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

105 participants in 2 patient groups

T2762
Experimental group
Treatment:
Device: T2762
Vismed®
Active Comparator group
Treatment:
Device: Vismed®

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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