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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T2380 | Drug | 200 microlitres of T2380 will be administrated intracamerally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Efficacy Variable is Response Based on the Realisation of the Capsulorhexis Without Use of Any Additive Mydriatic Treatment. | Day 0 |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph COLIN | Principal Investigator | |
| Marc LABETOULLE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratoires Thea | Clermont-Ferrand | 63430 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32126990 | Derived | 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. | |
| 26531052 |
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The patients, fulfilling the criteria for inclusion were invited to participate in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | T2380 | T2380: Intracameral administration during surgery |
| FG001 | Reference Group | Mydriatics and anesthetics: Topical treatments used the day of surgery |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
609 patients have signed the informed consent, but 18 patients were not selected and /or not randomised.
591 patients were randomised (at selection visit).
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| ID | Title | Description |
|---|---|---|
| BG000 | T2380 | T2380: Intracameral administration during surgery |
| BG001 | Reference Group | Mydriatics and anesthetic: Topical treatments used the day of surgery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Primary Efficacy Variable is Response Based on the Realisation of the Capsulorhexis Without Use of Any Additive Mydriatic Treatment. | 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. | Posted | Number | percentage of responders | Day 0 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | T2380 | T2380: Intracameral administration during surgery |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Macular oedema | Eye disorders | MedDRA 12.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical director | Laboratoires Thea | 33-4-73-98-14-36 | p.pouliquen@laboratoires-thea.fr |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D009184 | Mydriatics |
| D014331 | Tropicamide |
| D013748 | Tetracaine |
| ID | Term |
|---|---|
| D001337 | Autonomic Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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| Mydriatics |
| Drug |
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 | Two drops of tetracaine were instilled in the eye to be operated 5 minutes and 1 minute before surgery |
|
|
| Derived |
| 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. |
| Lost to Follow-up |
|
| Protocol Violation |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 4 |
| 295 |
| 0 |
| 295 |
| EG001 | Reference Group | Mydriatics and anesthetic: Topical treatments used the day of surgery | 6 | 296 | 0 | 296 |
| Keratitis | Eye disorders | MedDRA (12.0) | Systematic Assessment |
|
| Cataract operation complication | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Eye haemorrhage | Eye disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Retinal detachment | Eye disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Posterior capsule rupture | Eye disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Vascular bypass dysfunction | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
|
All the results of the Trial are the sole and exclusive property of THEA, and cannot be used in whatever form without prior written agreement of THEA.
| D020164 | Chemical Actions and Uses |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |