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OpenTrials
Completed

NCT Number: NCT01568593

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Paris, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

T2750

Device

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

Vismed

Device

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

Primary outcomes

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

    Time frame: Baseline and 35 days

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

Sponsors and collaborators

Lead sponsor

Laboratoires Thea

Industry

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 2, 2012
Registry last updated
Apr 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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