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Trial record 12 of 26 for:    "Bacterial Conjunctivitis" | "Anti-Bacterial Agents"

Clinical and Microbial Efficacy of ISV403 in Bacterial Conjunctivitis

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ClinicalTrials.gov Identifier: NCT00622908
Recruitment Status : Completed
First Posted : February 25, 2008
Results First Posted : August 13, 2009
Last Update Posted : March 24, 2015
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Bacterial Conjunctivitis
Interventions Drug: ISV-403
Drug: Vehicle
Enrollment 270
Recruitment Details Study was started on 12/28/04 and last patient last visit was 6/7/05. This study took place at 35 centers in the US.
Pre-assignment Details 270 subjects were enrolled, 269 were randomized(1 subject refused culture), 118 of which had bacteriologically confirmed acute bacterial conjunctivitis at baseline.
Arm/Group Title ISV-403 Vehicle
Hide Arm/Group Description 0.6% ISV-403 Vehicle of ISV-403
Period Title: Overall Study
Started 137 [1] 132 [1]
Completed 134 122
Not Completed 3 10
Reason Not Completed
Protocol Violation             1             0
Adverse Event             0             1
Lack of Efficacy             1             7
Lost to Follow-up             1             0
Refusal             0             1
Termination by study sponser             0             1
[1]
Intent to treat population
Arm/Group Title ISV-403 Vehicle Total
Hide Arm/Group Description 0.6% ISV-403 Vehicle of ISV-403 Total of all reporting groups
Overall Number of Baseline Participants 137 132 269
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 137 participants 132 participants 269 participants
33.3  (22.3) 35.1  (22.4) 34.2  (22.3)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 137 participants 132 participants 269 participants
< 2 years 2 1 3
2 to 19 Years 44 37 81
20 to 59 Years 71 71 142
>/=60 Years 20 23 43
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 137 participants 132 participants 269 participants
Female
86
  62.8%
76
  57.6%
162
  60.2%
Male
51
  37.2%
56
  42.4%
107
  39.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 137 participants 132 participants 269 participants
Caucasian 116 106 222
Asian 2 2 4
Black or African American 6 11 17
Hispanic 12 8 20
Other 1 5 6
1.Primary Outcome
Title Clinical Resolution of Baseline Bacterial Conjunctivitis (Day 8 or 9)
Hide Description Resolution of conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection.
Time Frame Visit 3 - day 8 or 9
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population, culture confirmed. Missing values and discontinued patients imputed as failures.
Arm/Group Title ISV-403 Vehicle
Hide Arm/Group Description:
0.6% ISV-403
Vehicle of ISV-403
Overall Number of Participants Analyzed 60 56
Measure Type: Number
Unit of Measure: Participants
37 20
2.Primary Outcome
Title Eradication of Baseline Pathogens (Day 8 or 9)
Hide Description Bacterial species eradication of baseline bacterial infection
Time Frame Visit 3 - Day 8 or day 9
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population, culture confirmed. Missing values and discontinued patients imputed as failures.
Arm/Group Title ISV-403 Vehicle
Hide Arm/Group Description:
0.6% ISV-403
Vehicle of ISV-403
Overall Number of Participants Analyzed 60 55
Measure Type: Number
Unit of Measure: Participants
54 38
3.Secondary Outcome
Title Clinical Resolution of Baseline Bacterial Conjunctivitis Day 4 (+/- 1 Day)
Hide Description The absence of conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection.
Time Frame Visit 2 - Day 4 (+/- 1 day)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population, culture confirmed. Missing values and discontinued patients imputed as failures.
Arm/Group Title ISV-403 Vehicle
Hide Arm/Group Description:
0.6% ISV-403
Vehicle of ISV-403
Overall Number of Participants Analyzed 60 56
Measure Type: Number
Unit of Measure: Participants
14 8
4.Secondary Outcome
Title Eradication of Baseline Pathogens Day 4 (+/- 1 Day)
Hide Description Bacterial species eradication of baseline bacterial infection
Time Frame Visit 2 - Day 4 (+/- 1 day)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population, culture confirmed. Missing values and discontinued patients imputed as failures.
Arm/Group Title ISV-403 Vehicle
Hide Arm/Group Description:
0.6% ISV-403
Vehicle of ISV-403
Overall Number of Participants Analyzed 60 54
Measure Type: Number
Unit of Measure: Participants
54 28
Time Frame Treated period was 5 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ISV-403 Vehicle
Hide Arm/Group Description 0.6% ISV-403 Vehicle of ISV-403
All-Cause Mortality
ISV-403 Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
ISV-403 Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/137 (0.73%)      1/132 (0.76%)    
Nervous system disorders     
Loss of Consciousness  1 [1]  1/137 (0.73%)  1 1/132 (0.76%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
[1]
Dehydration, not related to study medication
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ISV-403 Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   45/137 (32.85%)      46/132 (34.85%)    
Eye disorders     
Eye Pain  1  16/137 (11.68%)  24 8/132 (6.06%)  24
Blurred Vision  1  15/137 (10.95%)  28 13/132 (9.85%)  28
Eye Irritation  1  11/137 (8.03%)  27 16/132 (12.12%)  27
Eye Pruritis  1  3/137 (2.19%)  12 9/132 (6.82%)  12
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
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.
Sponsor has 45 days to review materials and provide comments back to the investigator.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Timothy Comstock
Organization: Bausch & Lomb Incorporated
Phone: (585) 338-6631
EMail: timothy.comstock@bausch.com
Layout table for additonal information
Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00622908     History of Changes
Other Study ID Numbers: 373
First Submitted: February 14, 2008
First Posted: February 25, 2008
Results First Submitted: June 29, 2009
Results First Posted: August 13, 2009
Last Update Posted: March 24, 2015