CataractPhase 3NCT02101359

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

A Phase 3 study testing T2380, Mydriatics and Tetracaine in people with Cataract, run by Laboratoires Thea at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 40 to 88 years
Conditions the study is for: Cataract
What is being tested?: T2380, Mydriatics and Tetracaine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 609 participants
Where: 1 siteFrance
Study dates: Jun 2011to May 2013
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 88 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Signed and dated informed consent
Male or female aged from 40 to 88 years old
Scheduled to undergo unilateral cataract surgery

Who cannot join

Combined surgery
Previous intraocular surgery

Trial locations and contacts

1 site in 1 country.

France1 site

Laboratoires Thea
Clermont-Ferrand, 63430

Other trials in France

About this study

Official title: Efficacy and Safety Assessment of Intracameral Injection of T2380 in Cataract Surgery Versus Reference Group (Topical Mydriatics and Anaesthetic)

Read the detailed 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).

Conditions: Cataract
Being tested: T2380, Mydriatics, Tetracaine
Medical subject headings: Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

T2380Drug
200 microlitres of T2380 will be administrated intracamerally
MydriaticsDrug
Also called Tropicamide, Phenylpehrine
3 drops of tropicamide and phenylephrine were instilled 30 minutes before surgery. The second and the third instillation of both phenylephrine and tropicamide will be realised respectively within 20 and 10 minutes before surgery.
TetracaineDrug
Also called Tetracaine 1%
Two drops of tetracaine were instilled in the eye to be operated 5 minutes and 1 minute before surgery

Study groups in NCT02101359
Study group	Role	What they receive
T2380	Experimental	Topical anaesthetic: Tetracaine was instilled in the eye to be operated before surgery. At the beginning of surgery, 200 μL of T2380 were administrated intracamerally. Receives: Drug: T2380; Drug: Tetracaine
Mydriatics and anesthetic	Active comparator	Topical anaesthetic: Tetracaine was instilled in the eye to be operated before surgery. Topical Mydriatic treatments were instilled three times before surgery. Receives: Drug: Mydriatics; Drug: Tetracaine

What is being measured

The primary outcome is the main question the study is designed to answer.

The Primary Efficacy Variable is Response Based on the Realisation of the Capsulorhexis Without Use of Any Additive Mydriatic Treatment.
Measured: Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2011May 2013

First posted2 Apr 2014 (estimated)
Study startJun 2011
Primary completionJan 2013
Study completionMay 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for CataractStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 609 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02101359
Sponsor's protocol ID: LT2380-PIII-05/10
Status last verified: Nov 2014
First submitted: 4 Sep 2013
Last updated: 14 Nov 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Labetoulle M, Behndig A, Tassignon MJ, Nuijts R, Mencucci R, Guell JL, Pleyer U, Szaflik J, Rosen P, Berard A, Chiambaretta F, Cochener-Lamard B; Intracameral Mydrane (ICMA), Ethics Group. Safety and efficacy of a standardized intracameral combination of mydriatics and anesthetic for cataract surgery in type-2 diabetic patients. BMC Ophthalmol. 2020 Mar 3;20(1):81. doi: 10.1186/s12886-020-01343-x.
PubMed 32126990
Labetoulle M, Findl O, Malecaze F, Alio J, Cochener B, Lobo C, Lazreg S, Hartani D, Colin J, Tassignon MJ, Behndig A; Intracameral Mydrane Study 2 Group. Evaluation of the efficacy and safety of a standardised intracameral combination of mydriatics and anaesthetics for cataract surgery. Br J Ophthalmol. 2016 Jul;100(7):976-985. doi: 10.1136/bjophthalmol-2015-307587. Epub 2015 Nov 3.
PubMed 26531052

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cataract trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety Assessment of Intracameral Injection of T2380 in Cataract Surgery Versus Reference Group (Topical Mydriatics and Anaesthetic)
ClinicalTrials.gov ID: NCT02101359
Acronym / sponsor ID: LT2380-PIII-05/10
Conditions: Cataract
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 609 participants (actual)
Lead sponsor: Laboratoires TheaIndustry (pharma, biotech, devices)
Study start: Jun 2011
Primary completion: Jan 2013 (actual)
Study completion: May 2013 (actual)
First posted: 2 Apr 2014 (estimated)
Results: Posted 25 Sep 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
T2380	Experimental	Drug: T2380, Drug: TetracaineTopical anaesthetic: Tetracaine was instilled in the eye to be operated before surgery. At the beginning of surgery, 200 μL of T2380 were administrated intracamerally.
Mydriatics and anesthetic	Active comparator	Drug: Mydriatics, Drug: TetracaineTopical anaesthetic: Tetracaine was instilled in the eye to be operated before surgery. Topical Mydriatic treatments were instilled three times before surgery.

Who may qualify

Ages: 40 to 88 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Signed and dated informed consent
Male or female aged from 40 to 88 years old
Scheduled to undergo unilateral cataract surgery

Key exclusion criteria (2 listed)

Combined surgery
Previous intraocular surgery

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
T2380200 microlitres of T2380 will be administrated intracamerally	Drug	T2380
MydriaticsAlso: Tropicamide, Phenylpehrine3 drops of tropicamide and phenylephrine were instilled 30 minutes before surgery. The second and the third instillation of both phenylephrine and tropicamide will be realised respectively within 20 and 10 minutes before surgery.	Drug	Mydriatics and anesthetic
TetracaineAlso: Tetracaine 1%Two drops of tetracaine were instilled in the eye to be operated 5 minutes and 1 minute before surgery	Drug	Mydriatics and anesthetic, T2380

Primary outcome

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

Results and safety

Results posted to the registry on 25 Sep 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
T2380	295	266
Reference Group	296	277

Primary outcome: The Primary Efficacy Variable is Response Based on the Realisation of the Capsulorhexis Without Use of Any Additive Mydriatic Treatment.

Time frame: Day 0. Number. Unit: percentage of responders

Measure	T2380 n = 268	Reference Group n = 281
Value	98.9	94.7

Population analysed: 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.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
T2380	4 of 295 (1.4%)	0 of 295 (0%)	Not reported
Reference Group	6 of 296 (2%)	0 of 296 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32126990Labetoulle M, Behndig A, Tassignon MJ, Nuijts R, Mencucci R, Guell JL, Pleyer U, Szaflik J, Rosen P, Berard A, Chiambaretta F, Cochener-Lamard B; Intracameral Mydrane (ICMA), Ethics Group. Safety and efficacy of a standardized intracameral combination of mydriatics and anesthetic for cataract surgery in type-2 diabetic patients. BMC Ophthalmol. 2020 Mar 3;20(1):81. doi: 10.1186/s12886-020-01343-x.
Derived from this study: PubMed 26531052Labetoulle M, Findl O, Malecaze F, Alio J, Cochener B, Lobo C, Lazreg S, Hartani D, Colin J, Tassignon MJ, Behndig A; Intracameral Mydrane Study 2 Group. Evaluation of the efficacy and safety of a standardised intracameral combination of mydriatics and anaesthetics for cataract surgery. Br J Ophthalmol. 2016 Jul;100(7):976-985. doi: 10.1136/bjophthalmol-2015-307587. Epub 2015 Nov 3.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Joseph COLIN principal investigator

Marc LABETOULLE principal investigator

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing T2380, Mydriatics and Tetracaine in people with Cataract, run by Laboratoires Thea at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Primary Efficacy Variable is Response Based on the Realisation of the Capsulorhexis Without Use of Any Additive Mydriatic Treatment. (time frame: Day 0). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02101359, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2014.