Phase 3
Completed N=591
Efficacy and Safety Assessment of Intracameral Injection of T2380 in Cataract Surgery
Source: ClinicalTrials.gov NCT02101359 ↗Enrolled (actual)
591
Serious AEs
1.7%
Results posted
Sep 2014
Primary outcomePrimary: The Primary Efficacy Variable is Response Based on the Realisation of the Capsulorhexis Without Use of Any Additive Mydriatic Treatment. — 98.9; 94.7 percentage of responders
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Efficacy Variable is Response Based on the Realisation of the Capsulorhexis Without Use of Any Additive Mydriatic Treatment. |
98.9; 94.7 | — |
Eligibility Criteria
Inclusion Criteria
- Signed and dated informed consent
- Male or female aged from 40 to 88 years old
- Scheduled to undergo unilateral cataract surgery
Exclusion criteria
- Combined surgery
- Previous intraocular surgery
Data sourced from ClinicalTrials.gov (NCT02101359). 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. Informational only — not medical advice.