Trial · NCT02101359

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

NCT02101359, Phase 3, Completed, Laboratoires Thea; results first posted 2014-09-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety Assessment of Intracameral Injection of T2380 in Cataract Surgery. Trials, record NCT02101359. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02101359

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy and Safety Assessment of Intracameral Injection of T2380 in Cataract Surgery
NCT number: NCT02101359
Status: Completed
Phases: Phase 3
Enrollment: 609 participants, actual
Lead sponsor: Laboratoires Thea
Conditions: Cataract
Interventions: T2380, Mydriatics, Tetracaine
First posted: 2014-04-02
Last updated: 2014-11-14
Results first posted: 2014-09-25

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	The Primary Efficacy Variable is Response Based on the Realisation of the Capsulorhexis Without Use of Any Additive Mydriatic Treatment.	Day 0

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	The Primary Efficacy Variable is Response Based on the Realisation of the Capsulorhexis Without Use of Any Additive Mydriatic Treatment.	Day 0	Modified ITT (mITT) Set: All randomised patients for whom there was evidence they used the study medication, and who satisfied the non-inclusion criterion concerning unauthorized previous and concomitant medications. Patients were assigned to the treatment group as treated.	percentage of responders	NUMBER

Source ClinicalTrials.gov

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
The Primary Efficacy Variable is Response Based on the Realisation of the Capsulorhexis Without Use of Any Additive Mydriatic Treatment.	T2380		98.9		percentage of responders
The Primary Efficacy Variable is Response Based on the Realisation of the Capsulorhexis Without Use of Any Additive Mydriatic Treatment.	Reference Group		94.7		percentage of responders

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	T2380	295
Overall Study	STARTED	Reference Group	296
Overall Study	COMPLETED	T2380	266
Overall Study	COMPLETED	Reference Group	277
Overall Study	NOT COMPLETED	T2380	29
Overall Study	NOT COMPLETED	Reference Group	19

Source ClinicalTrials.gov

Adverse events20

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
serious	Macular oedema	Eye disorders	T2380	1	295
serious	Macular oedema	Eye disorders	Reference Group	0	296
serious	Keratitis	Eye disorders	T2380	1	295
serious	Keratitis	Eye disorders	Reference Group	0	296
serious	Cataract operation complication	Injury, poisoning and procedural complications	T2380	1	295
serious	Cataract operation complication	Injury, poisoning and procedural complications	Reference Group	0	296
serious	Transient ischaemic attack	Nervous system disorders	T2380	1	295
serious	Transient ischaemic attack	Nervous system disorders	Reference Group	0	296
serious	Eye haemorrhage	Eye disorders	T2380	0	295
serious	Eye haemorrhage	Eye disorders	Reference Group	1	296

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	T2380
Total, all-cause mortality	Reference Group
Total, other adverse events	T2380	0	295
Total, other adverse events	Reference Group	0	296
Total, serious adverse events	T2380	4	295
Total, serious adverse events	Reference Group	6	296

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
26531052	DERIVED	PubMed
32126990	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
T2380 vs Reference Group: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02101359

GET https://conductscience.org/api/trials/v1/NCT02101359/registered

API reference For AI assistants