Trial Outcomes & Findings for The Effects of BAK on the Blood Aqueous Barrier of Pseudophakic Patients (NCT NCT01280110)
NCT ID: NCT01280110
Last Updated: 2012-07-18
Results Overview
Aqueous humor flare indicates the degree of a break in the blood-aqueous barrier. It is objectively measured with a Laser flare meter.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
44 participants
Primary outcome timeframe
Baseline, 15 days and 30 days.
Results posted on
2012-07-18
Participant Flow
Recruitment period started on March 2011 through December 2011 in the Department of Ophthalmology at the Hospital das Clínicas - State University of Campinas.
Participant milestones
| Measure |
Preserved (BAK 0.006%) Lubricating Drop
One group will receive preserved lubricating drops 4 times a day for 1 month.
|
Preservative-free Lubricating Drops
The second group will receive preservative-free lubricating drops 4 times a day for 1 month.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
|
Overall Study
COMPLETED
|
22
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effects of BAK on the Blood Aqueous Barrier of Pseudophakic Patients
Baseline characteristics by cohort
| Measure |
Preserved (BAK 0.006%) Lubricating Drop
n=22 Participants
One group will receive preserved lubricating drops 4 times a day for 1 month.
|
Preservative-free Lubricating Drops
n=22 Participants
The second group will receive preservative-free lubricating drops 4 times a day for 1 month.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
|
Age Continuous
|
69 years
STANDARD_DEVIATION 10.7 • n=93 Participants
|
65.2 years
STANDARD_DEVIATION 12.2 • n=4 Participants
|
67.1 years
STANDARD_DEVIATION 11.5 • n=27 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Region of Enrollment
Brazil
|
22 participants
n=93 Participants
|
22 participants
n=4 Participants
|
44 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, 15 days and 30 days.Population: Statiscal power of 80%.
Aqueous humor flare indicates the degree of a break in the blood-aqueous barrier. It is objectively measured with a Laser flare meter.
Outcome measures
| Measure |
Preserved (BAK 0.006%) Lubricating Drop
n=22 Participants
One group will receive preserved lubricating drops 4 times a day for 1 month. The flare will be evaluated with Laser Flare Cell Meter (Kowa, FM 500, Japan). The patients will have 3 evaluations (baseline, 15 days and 30 days). The baseline measure is done before the use of the eyedrops.
|
Preservative-free Lubricating Drops
n=22 Participants
he second group will receive preservative-free lubricating drops 4 times a day for 1 month. The flare will be evaluated with Laser Flare Cell Meter (Kowa, FM 500, Japan). The patients will have 3 evaluations (baseline, 15 days and 30 days). The baseline measure is done before the use of the eyedrops.
|
|---|---|---|
|
Aqueous Humor Flare
Baseline
|
8.4 photons/msec
Standard Deviation 2.7
|
9.3 photons/msec
Standard Deviation 2.6
|
|
Aqueous Humor Flare
15 days
|
11.4 photons/msec
Standard Deviation 5.1
|
8.4 photons/msec
Standard Deviation 2.8
|
|
Aqueous Humor Flare
30 days
|
11.9 photons/msec
Standard Deviation 5.9
|
8.4 photons/msec
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Baseline, 15 days and 30 days.Population: Statiscal power of 80%
Macular thickness will be measured with an Optical coherence tomography (OCT). Measures 5% under the normal population according to the OCT software will be considered break in the blood-retina barrier.
Outcome measures
| Measure |
Preserved (BAK 0.006%) Lubricating Drop
n=22 Participants
One group will receive preserved lubricating drops 4 times a day for 1 month. The flare will be evaluated with Laser Flare Cell Meter (Kowa, FM 500, Japan). The patients will have 3 evaluations (baseline, 15 days and 30 days). The baseline measure is done before the use of the eyedrops.
|
Preservative-free Lubricating Drops
n=22 Participants
he second group will receive preservative-free lubricating drops 4 times a day for 1 month. The flare will be evaluated with Laser Flare Cell Meter (Kowa, FM 500, Japan). The patients will have 3 evaluations (baseline, 15 days and 30 days). The baseline measure is done before the use of the eyedrops.
|
|---|---|---|
|
Macular Thickness
Baseline
|
258.5 μm
Standard Deviation 26.7
|
259.2 μm
Standard Deviation 26.8
|
|
Macular Thickness
15 days
|
254.9 μm
Standard Deviation 24.2
|
256.4 μm
Standard Deviation 27.6
|
|
Macular Thickness
30 days
|
255.9 μm
Standard Deviation 25.1
|
258.3 μm
Standard Deviation 29.1
|
Adverse Events
Preserved (BAK 0.006%) Lubricating Drop
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Preservative-free Lubricating Drops
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
Vital Paulino Costa
Departamento de Oftalmologia - Universidade Estadual de Campinas - Campinas - Brazil
Phone: 55-19-35217396
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place