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Trial record 8 of 10 for:    "Lens Disease" | "Phenylephrine"

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

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ClinicalTrials.gov Identifier: NCT02101359
Recruitment Status : Completed
First Posted : April 2, 2014
Results First Posted : September 25, 2014
Last Update Posted : November 14, 2014
Sponsor:
Information provided by (Responsible Party):
Laboratoires Thea

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cataract
Interventions Drug: T2380
Drug: Mydriatics
Drug: Tetracaine
Enrollment 609
Recruitment Details The patients, fulfilling the criteria for inclusion were invited to participate in the study.
Pre-assignment Details  
Arm/Group Title T2380 Reference Group
Hide Arm/Group Description T2380: Intracameral administration during surgery Mydriatics and anesthetics: Topical treatments used the day of surgery
Period Title: Overall Study
Started 295 296
Completed 266 277
Not Completed 29 19
Reason Not Completed
Not included             23             13
Withdrawal by Subject             5             4
Lost to Follow-up             1             0
Protocol Violation             0             2
Arm/Group Title T2380 Reference Group Total
Hide Arm/Group Description T2380: Intracameral administration during surgery Mydriatics and anesthetic: Topical treatments used the day of surgery Total of all reporting groups
Overall Number of Baseline Participants 295 296 591
Hide Baseline Analysis Population Description
609 patients have signed the informed consent, but 18 patients were not selected and /or not randomised. 591 patients were randomised (at selection visit).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 295 participants 296 participants 591 participants
69.2  (9.4) 70.6  (9.2) 69.9  (9.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 295 participants 296 participants 591 participants
Female
120
  40.7%
134
  45.3%
254
  43.0%
Male
175
  59.3%
162
  54.7%
337
  57.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 295 participants 296 participants 591 participants
Algeria 32 31 63
Austria 11 10 21
Belgium 17 16 33
France 192 188 380
Germany 9 8 17
Italy 11 11 22
Spain 6 11 17
Sweden 9 9 18
Portugal 8 12 20
1.Primary Outcome
Title The Primary Efficacy Variable is Response Based on the Realisation of the Capsulorhexis Without Use of Any Additive Mydriatic Treatment.
Hide Description [Not Specified]
Time Frame Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title T2380 Reference Group
Hide Arm/Group Description:
T2380: Intracameral administration during surgery
Mydriatics and anesthetic: Topical treatments used the day of surgery
Overall Number of Participants Analyzed 268 281
Measure Type: Number
Unit of Measure: percentage of responders
98.9 94.7
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title T2380 Reference Group
Hide Arm/Group Description T2380: Intracameral administration during surgery Mydriatics and anesthetic: Topical treatments used the day of surgery
All-Cause Mortality
T2380 Reference Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
T2380 Reference Group
Affected / at Risk (%) Affected / at Risk (%)
Total   4/295 (1.36%)   6/296 (2.03%) 
Cardiac disorders     
Acute coronary syndrome * 2  0/295 (0.00%)  1/296 (0.34%) 
Eye disorders     
Macular oedema  1  1/295 (0.34%)  0/296 (0.00%) 
Keratitis  2  1/295 (0.34%)  0/296 (0.00%) 
Eye haemorrhage * 2  0/295 (0.00%)  1/296 (0.34%) 
Retinal detachment * 2  0/295 (0.00%)  1/296 (0.34%) 
Posterior capsule rupture * 2  0/295 (0.00%)  1/296 (0.34%) 
Injury, poisoning and procedural complications     
Cataract operation complication  2  1/295 (0.34%)  0/296 (0.00%) 
Vascular bypass dysfunction * 2  0/295 (0.00%)  1/296 (0.34%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Prostate cancer * 2  0/295 (0.00%)  1/296 (0.34%) 
Nervous system disorders     
Transient ischaemic attack * 2  1/295 (0.34%)  0/296 (0.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.0
2
Term from vocabulary, MedDRA (12.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
T2380 Reference Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/295 (0.00%)   0/296 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical director
Organization: Laboratoires Thea
Phone: 33-4-73-98-14-36
EMail: p.pouliquen@laboratoires-thea.fr
Layout table for additonal information
Responsible Party: Laboratoires Thea
ClinicalTrials.gov Identifier: NCT02101359     History of Changes
Other Study ID Numbers: LT2380-PIII-05/10
First Submitted: September 4, 2013
First Posted: April 2, 2014
Results First Submitted: September 19, 2014
Results First Posted: September 25, 2014
Last Update Posted: November 14, 2014