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Trial record 10 of 26 for:    "Bacterial Conjunctivitis" | "Anti-Bacterial Agents"

Besifloxacin Ophthalmic Suspension Verses Gatifloxacin Ophthalmic Solution in Neonates With Bacterial Conjunctivitis

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ClinicalTrials.gov Identifier: NCT01330355
Recruitment Status : Terminated (Lack of enrollment)
First Posted : April 6, 2011
Results First Posted : September 3, 2014
Last Update Posted : September 3, 2014
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Care Provider, Investigator);   Primary Purpose: Treatment
Condition Bacterial Conjunctivitis
Interventions Drug: Besivance
Drug: Gatifloxacin
Enrollment 33
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Besivance Gatifloxacin
Hide Arm/Group Description

Besifloxacin 0.6% ophthalmic suspension

Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days

Gatifloxacin 0.3% ophthalmic solution

Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days

Period Title: Overall Study
Started 16 17
Completed 16 17
Not Completed 0 0
Arm/Group Title Besivance Gatifloxacin Total
Hide Arm/Group Description

Besifloxacin 0.6% ophthalmic suspension

Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days

Gatifloxacin 0.3% ophthalmic solution

Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days

Total of all reporting groups
Overall Number of Baseline Participants 16 17 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Days
Number Analyzed 16 participants 17 participants 33 participants
17
(6 to 26)
14
(5 to 25)
14
(5 to 26)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 17 participants 33 participants
Female
12
  75.0%
7
  41.2%
19
  57.6%
Male
4
  25.0%
10
  58.8%
14
  42.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 17 participants 33 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   6.3%
1
   5.9%
2
   6.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
   5.9%
1
   3.0%
White
12
  75.0%
12
  70.6%
24
  72.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
  18.8%
3
  17.6%
6
  18.2%
1.Primary Outcome
Title Clinical Resolution
Hide Description Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia.
Time Frame Visit 5 (Day 8+1)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population only includes those for whom the outcome was measured within the specified time frame.
Arm/Group Title Besivance Gatifloxacin
Hide Arm/Group Description:

Besifloxacin 0.6% ophthalmic suspension

Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days

Gatifloxacin 0.3% ophthalmic solution

Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days

Overall Number of Participants Analyzed 16 16
Measure Type: Number
Unit of Measure: participants
12 12
2.Secondary Outcome
Title Clinical Resolution
Hide Description Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia.
Time Frame Visit 3 (Day 3)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population only includes those for whom the outcome was measured within the specified time frame.
Arm/Group Title Besivance Gatifloxacin
Hide Arm/Group Description:

Besifloxacin 0.6% ophthalmic suspension

Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days

Gatifloxacin 0.3% ophthalmic solution

Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days

Overall Number of Participants Analyzed 16 16
Measure Type: Number
Unit of Measure: participants
3 5
3.Secondary Outcome
Title Microbial Eradication
Hide Description Eradication defined as the absence of all accepted ocular bacterial species (as measured on the ordinal scale) that were present at or above threshold at baseline
Time Frame Visit 5 (Day 8+1)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population only includes those for whom the outcome was measured within the specified time frame.
Arm/Group Title Besivance Gatifloxacin
Hide Arm/Group Description:

Besifloxacin 0.6% ophthalmic suspension

Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days

Gatifloxacin 0.3% ophthalmic solution

Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days

Overall Number of Participants Analyzed 13 9
Measure Type: Number
Unit of Measure: participants
12 8
4.Secondary Outcome
Title Microbial Outcome
Hide Description

Microbial outcome for the following groups of accepted ocular bacterial species that were present at or above threshold at baseline:

  • over all bacterial species
  • over all and individual gram-positive bacterial species
  • over all and individual gram-negative bacterial species
Time Frame Visit 3 (Day 3) and Visit 5 (Day 8+1)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population only includes those for whom the outcome was measured within the specified time frame. A subject may have tested positive for multiple bacterial species (up to 5 species).
Arm/Group Title Besivance Gatifloxacin
Hide Arm/Group Description:

Besifloxacin 0.6% ophthalmic suspension

Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days

Gatifloxacin 0.3% ophthalmic solution

Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days

Overall Number of Participants Analyzed 13 9
Measure Type: Number
Unit of Measure: events
Visit 3 (Day 3) Gram-Positive 16 6
Visit 3 (Day 3) Gram-Negative 6 3
Visit 5 (Day 8) Gram-Positive 17 12
Visit 5 (Day8) Gram-Negative 6 4
Time Frame The period of observation for collection of AEs extended from the time the subject’s parent/legally authorized representative provided informed consent until the last study visit, Visit 5.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Besivance Gatifloxacin
Hide Arm/Group Description

Besifloxacin 0.6% ophthalmic suspension

Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days

Gatifloxacin 0.3% ophthalmic solution

Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days

All-Cause Mortality
Besivance Gatifloxacin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Besivance Gatifloxacin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/16 (0.00%)      0/17 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Besivance Gatifloxacin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/16 (0.00%)      5/17 (29.41%)    
Eye disorders     
Conjunctivitis Bacterial   0/16 (0.00%)  0 1/17 (5.88%)  1
Gastrointestinal disorders     
Abdominal Pain   0/16 (0.00%)  0 1/17 (5.88%)  1
Psychiatric disorders     
Irritability   0/16 (0.00%)  0 1/17 (5.88%)  1
Respiratory, thoracic and mediastinal disorders     
Rhinorrhoea   0/16 (0.00%)  0 1/17 (5.88%)  1
Skin and subcutaneous tissue disorders     
Acne Infantile   0/16 (0.00%)  0 1/17 (5.88%)  1
Dermatitis   0/16 (0.00%)  0 1/17 (5.88%)  1
Indicates events were collected by systematic assessment
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.
For a period of ten years, the PI agrees to keep confidential and not disclose, without the prior written consent of Sponsor, to any third party or use any technology, data, reports, results of clinical studies conducted under this Study or other information received by Sponsor, or any technology, data, reports, study materials, or other information developed by Sponsor unless disclosure by PI is required by law.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Johnson Varughese
Organization: Valeant Pharmaceuticals
Phone: 908-541-2179
EMail: Johnson.Varughese@valeant.com
Layout table for additonal information
Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01330355     History of Changes
Other Study ID Numbers: 646
First Submitted: April 5, 2011
First Posted: April 6, 2011
Results First Submitted: August 21, 2014
Results First Posted: September 3, 2014
Last Update Posted: September 3, 2014