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The Effects of BAK on the Blood Aqueous Barrier of Pseudophakic Patients

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ClinicalTrials.gov Identifier: NCT01280110
Recruitment Status : Completed
First Posted : January 20, 2011
Results First Posted : July 12, 2012
Last Update Posted : July 18, 2012
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Vital Paulino Costa, University of Campinas, Brazil

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Dry Eye Syndromes
Interventions Drug: Hydroxypropylmethylcellulose
Drug: Carboxymethylcellulose
Enrollment 44
Recruitment Details Recruitment period started on March 2011 through December 2011 in the Department of Ophthalmology at the Hospital das Clínicas - State University of Campinas.
Pre-assignment Details  
Arm/Group Title Preserved (BAK 0.006%) Lubricating Drop Preservative-free Lubricating Drops
Hide Arm/Group Description One group will receive preserved lubricating drops 4 times a day for 1 month. The second group will receive preservative-free lubricating drops 4 times a day for 1 month.
Period Title: Overall Study
Started 22 22
Completed 22 22
Not Completed 0 0
Arm/Group Title Preserved (BAK 0.006%) Lubricating Drop Preservative-free Lubricating Drops Total
Hide Arm/Group Description One group will receive preserved lubricating drops 4 times a day for 1 month. The second group will receive preservative-free lubricating drops 4 times a day for 1 month. Total of all reporting groups
Overall Number of Baseline Participants 22 22 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
  27.3%
7
  31.8%
13
  29.5%
>=65 years
16
  72.7%
15
  68.2%
31
  70.5%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 22 participants 44 participants
69  (10.7) 65.2  (12.2) 67.1  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
Female
9
  40.9%
13
  59.1%
22
  50.0%
Male
13
  59.1%
9
  40.9%
22
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Brazil Number Analyzed 22 participants 22 participants 44 participants
22 22 44
1.Primary Outcome
Title Aqueous Humor Flare
Hide Description Aqueous humor flare indicates the degree of a break in the blood-aqueous barrier. It is objectively measured with a Laser flare meter.
Time Frame Baseline, 15 days and 30 days.
Hide Outcome Measure Data
Hide Analysis Population Description
Statiscal power of 80%.
Arm/Group Title Preserved (BAK 0.006%) Lubricating Drop Preservative-free Lubricating Drops
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: photons/msec
Baseline 8.4  (2.7) 9.3  (2.6)
15 days 11.4  (5.1) 8.4  (2.8)
30 days 11.9  (5.9) 8.4  (2.5)
2.Secondary Outcome
Title Macular Thickness
Hide Description 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.
Time Frame Baseline, 15 days and 30 days.
Hide Outcome Measure Data
Hide Analysis Population Description
Statiscal power of 80%
Arm/Group Title Preserved (BAK 0.006%) Lubricating Drop Preservative-free Lubricating Drops
Hide Arm/Group Description:
One group will receive preserved lubricating drops 4 times a day for 1 month. The central macular thickness was obtained through Cirrus™ HD-OCT (Zeiss). Mode 512x128 macular cube scan
The second group will receive preservative-free lubricating drops 4 times a day for 1 month. The central macular thickness was obtained through Cirrus™ HD-OCT (Zeiss). Mode 512x128 macular cube scan
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: μm
Baseline 258.5  (26.7) 259.2  (26.8)
15 days 254.9  (24.2) 256.4  (27.6)
30 days 255.9  (25.1) 258.3  (29.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Preserved (BAK 0.006%) Lubricating Drop Preservative-free Lubricating Drops
Hide Arm/Group Description One group will receive preserved lubricating drops 4 times a day for 1 month. The second group will receive preservative-free lubricating drops 4 times a day for 1 month.
All-Cause Mortality
Preserved (BAK 0.006%) Lubricating Drop Preservative-free Lubricating Drops
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Preserved (BAK 0.006%) Lubricating Drop Preservative-free Lubricating Drops
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/22 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Preserved (BAK 0.006%) Lubricating Drop Preservative-free Lubricating Drops
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/22 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Vital Paulino Costa
Organization: Departamento de Oftalmologia - Universidade Estadual de Campinas - Campinas - Brazil
Phone: 55-19-35217396
EMail: vp.costa@uol.com.br
Layout table for additonal information
Responsible Party: Vital Paulino Costa, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT01280110    
Other Study ID Numbers: VPC1
First Submitted: January 18, 2011
First Posted: January 20, 2011
Results First Submitted: June 7, 2012
Results First Posted: July 12, 2012
Last Update Posted: July 18, 2012