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Trial Outcomes & Findings for Assessment of the Concentrations of Besifloxacin, Moxifloxacin, or Gatifloxacin in the Aqueous Humor of Subjects (NCT NCT00824070)

NCT ID: NCT00824070

Last Updated: 2011-12-13

Results Overview

An aqueous humor specimen was collected from the study eye for determination of drug concentration 60 min after study drug instillation.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

105 participants

Primary outcome timeframe

Visit 2, 1-14 days following screening visit

Results posted on

2011-12-13

Participant Flow

This study was conducted a 6 sites in the US. This was a single dose study with first patient enrollment on 2/2/2009 and last patient visit was 7/9/2009.

105 subjects were screened at Visit 1 and qualified subjects returned on the day of surgery (Visit 2).

Participant milestones

Participant milestones
Measure
Besifloxacin
Besifloxacin ophthalmic suspension
Moxifloxacin
Vigamox (moxifloxacin ophthalmic solution, 0.5%)
Gatifloxacin
Zymar (gatifloxacin ophthalmic solution, 0.3%)
Overall Study
STARTED
34
35
36
Overall Study
COMPLETED
34
35
36
Overall Study
NOT COMPLETED
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assessment of the Concentrations of Besifloxacin, Moxifloxacin, or Gatifloxacin in the Aqueous Humor of Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Besifloxacin
n=34 Participants
Besifloxacin ophthalmic suspension
Moxifloxacin
n=35 Participants
Vigamox (moxifloxacin ophthalmic solution, 0.5%)
Gatifloxacin
n=36 Participants
Zymar (gatifloxacin ophthalmic solution, 0.3%)
Total
n=105 Participants
Total of all reporting groups
Age, Customized
<60 years
4 participants
8.1 • n=5 Participants
4 participants
9.9 • n=7 Participants
5 participants
9.6 • n=5 Participants
13 participants
n=4 Participants
Age, Customized
60-69 years
15 participants
n=5 Participants
7 participants
n=7 Participants
10 participants
n=5 Participants
32 participants
n=4 Participants
Age, Customized
70-79 years
11 participants
n=5 Participants
19 participants
n=7 Participants
14 participants
n=5 Participants
44 participants
n=4 Participants
Age, Customized
>/= 80
4 participants
n=5 Participants
5 participants
n=7 Participants
7 participants
n=5 Participants
16 participants
n=4 Participants
Sex: Female, Male
Female
18 Participants
n=5 Participants
21 Participants
n=7 Participants
20 Participants
n=5 Participants
59 Participants
n=4 Participants
Sex: Female, Male
Male
16 Participants
n=5 Participants
14 Participants
n=7 Participants
16 Participants
n=5 Participants
46 Participants
n=4 Participants
Race/Ethnicity, Customized
Caucasian
31 participants
n=5 Participants
33 participants
n=7 Participants
34 participants
n=5 Participants
98 participants
n=4 Participants
Race/Ethnicity, Customized
Non-Caucasian
3 participants
n=5 Participants
2 participants
n=7 Participants
2 participants
n=5 Participants
7 participants
n=4 Participants

PRIMARY outcome

Timeframe: Visit 2, 1-14 days following screening visit

Population: Statistical Analysis of AH Drug Concentration. Modified intent to treat population (mITT). Subjects with non-missing data.

An aqueous humor specimen was collected from the study eye for determination of drug concentration 60 min after study drug instillation.

Outcome measures

Outcome measures
Measure
Besifloxacin
n=32 eyes
Besifloxacin ophthalmic suspension
Moxifloxacin
n=35 eyes
Vigamox (moxifloxacin ophthalmic solution, 0.5%)
Gatifloxacin
n=34 eyes
Zymar (gatifloxacin ophthalmic solution, 0.3%)
The Aqueous Humor Drug Concentration.
0.1349 µg/mL
Standard Deviation 0.5820
0.6681 µg/mL
Standard Deviation 0.4980
0.1251 µg/mL
Standard Deviation 0.07624

Adverse Events

Besifloxacin

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Moxifloxacin

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Gatifloxacin

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tuyen Ong, MD

Bausch & Lomb Inc

Phone: (973) 360-6389

Results disclosure agreements

  • Principal investigator is a sponsor employee All study data generated as a result of this study will be regarded as confidential, until appropriate analysis and review by the Sponsor or its designee and the Investigator(s) are completed. The results of the study may be published or presented by the Investigator(s)after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed.
  • Publication restrictions are in place

Restriction type: OTHER