Efficacy and Safety Assessment of Intracameral Injection of T2380 in Cataract Surgery Versus Reference Group (Topical Mydriatics and Anaesthetic)
| Registry | NCT02101359 |
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| Status | Completed |
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| Phase | Phase 3 |
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| Study type | Interventional; randomized, parallel, masking: none, treatment |
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| Enrollment | 609 (Actual) |
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| Sponsor | Laboratoires Thea (Industry) |
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| Conditions | Cataract |
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| Interventions | T2380, Mydriatics, Tetracaine (Drug) |
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| Dates | start 2011-06-01, primary completion 2013-01-01, completion 2013-05-01, first posted 2014-04-02, last updated 2014-11-14 |
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| Locations | 1 site in France |
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Related Papers Related Patents Related Grants Related Experts
All trials for Cataract All trials of T2380 All trials of Mydriatics
-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.
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+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).
+Arms and interventions
| Arm | Type | Interventions | Description |
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| T2380 | Experimental | Drug: T2380; Drug: Tetracaine | 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. |
| Mydriatics and anesthetic | Active comparator | Drug: Mydriatics; Drug: Tetracaine | Topical anaesthetic: Tetracaine was instilled in the eye to be operated before surgery.
Topical Mydriatic treatments were instilled three times before surgery. |
- T2380 (Drug): 200 microlitres of T2380 will be administrated intracamerally
- Mydriatics (Drug), also known as 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.
- Tetracaine (Drug), also known as Tetracaine 1%: Two drops of tetracaine were instilled in the eye to be operated 5 minutes and 1 minute before surgery
+Outcome measures
Primary outcomes
- The Primary Efficacy Variable is Response Based on the Realisation of the Capsulorhexis Without Use of Any Additive Mydriatic Treatment. [Day 0]
+Eligibility
Sex: All, ages: 40 Years to 88 Years
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
+Posted results
Participant flow
| Milestone | T2380 | Reference Group |
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| Started | 295 | 296 |
| Completed | 266 | 277 |
| Not completed | 29 | 19 |
Outcome results
- The Primary Efficacy Variable is Response Based on the Realisation of the Capsulorhexis Without Use of Any Additive Mydriatic Treatment. (Primary), Number, percentage of responders: T2380 98.9; Reference Group 94.7
Adverse events
| Arm | Deaths | Serious adverse events | Other adverse events |
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| T2380 | 0 | 4/295 (1.4%) | 0/295 (0.0%) |
| Reference Group | 0 | 6/296 (2.0%) | 0/296 (0.0%) |
Serious adverse events by term
| Term | Organ system | T2380 | Reference Group |
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| Macular oedema | Eye disorders | 1/295 | 0/296 |
| Keratitis | Eye disorders | 1/295 | 0/296 |
| Cataract operation complication | Injury, poisoning and procedural complications | 1/295 | 0/296 |
| Transient ischaemic attack | Nervous system disorders | 1/295 | 0/296 |
| Eye haemorrhage | Eye disorders | 0/295 | 1/296 |
| Retinal detachment | Eye disorders | 0/295 | 1/296 |
| Posterior capsule rupture | Eye disorders | 0/295 | 1/296 |
| Vascular bypass dysfunction | Injury, poisoning and procedural complications | 0/295 | 1/296 |
| Acute coronary syndrome | Cardiac disorders | 0/295 | 1/296 |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/295 | 1/296 |
+Locations (1)
| Facility | City | Country | Status |
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| Laboratoires Thea | Clermont-Ferrand | France | |
+Publications
- Results publication: 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. PMID 32126990
- Results publication: 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. PMID 26531052
+Investigators
- Joseph COLIN, Principal investigator
- Marc LABETOULLE, Principal investigator