Efficacy and Safety Assessment of Intracameral Injection of T2380 in Cataract Surgery

Last updated: November 4, 2014
Sponsor: Laboratoires Thea
Overall Status: Completed

Phase

3

Condition

Vision Loss

Eye Disease

Eye Disorders/infections

Treatment

N/A

Clinical Study ID

NCT02101359
LT2380-PIII-05/10
  • Ages 40-88
  • All Genders

Study Summary

The purpose of this study is to determine the efficacy and safety assessment of T2380 for mydriasis and anaesthesia in phacoemulsification cataract surgery versus reference group (topical mydriatics and anaesthetic) 2X246 patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Signed and dated informed consent

  • Male or female aged from 40 to 88 years old

  • Scheduled to undergo unilateral cataract surgery

Exclusion

Exclusion criteria:

  • Combined surgery

  • Previous intraocular surgery

Study Design

Total Participants: 609
Study Start date:
June 01, 2011
Estimated Completion Date:
May 31, 2013

Study Description

In order to perform pupil size measurements and ocular discomfort assessments at specific times, the surgical procedure was divided into 5 time periods according to the following time points: T1 (just before first incision), T2 (just before viscoelastic injection), T3 (just before capsulorhexis), T4 (just before intraocular lens injection), and T5 (just before cefuroxime injection).

Connect with a study center

  • Laboratoires Thea

    Clermont- Ferrand, 63430
    France

    Site Not Available

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