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Trial record 10 of 12 for:    "Lens Disease" | "Loteprednol"

Clinical Outcomes and Evaluation of Lotemax 0.5% in Treatment of Ocular Inflammation Associated With Cataract Surgery

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ClinicalTrials.gov Identifier: NCT01344226
Recruitment Status : Completed
First Posted : April 29, 2011
Results First Posted : October 22, 2018
Last Update Posted : October 22, 2018
Sponsor:
Information provided by (Responsible Party):
Melissa Toyos, Toyos Clinic

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Conditions Pseudophakia
Inflammation
Intervention Drug: loteprednol 0.5% ophthalmic solution
Enrollment 49
Recruitment Details Patients in one location of one surgeon's clinic about to undergo cataract surgery were recruited from July 2011 to May 2013.
Pre-assignment Details patients had to be off of steroids for 14 days with no depot steroid injection for 30 days
Arm/Group Title Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati
Hide Arm/Group Description Subjects instilled one drop of topical loteprednol 0.5% suspension qid into the operative eye four times daily for a maximum of 22 days. Dosing began on the day of surgery and continued for 21 days postoperatively.
Period Title: Overall Study
Started 49
Completed 41
Not Completed 8
Reason Not Completed
Protocol Violation             2
Withdrawal by Subject             3
Lack of Efficacy             3
Arm/Group Title Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati
Hide Arm/Group Description patients received loteprednol 0.5% suspension for 21 days following surgery in addition to pre and postoperative standard of care
Overall Number of Baseline Participants 49
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants
<=18 years
0
   0.0%
Between 18 and 65 years
14
  28.6%
>=65 years
35
  71.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 49 participants
68.93  (9.61)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants
Female
30
  61.2%
Male
19
  38.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 49 participants
49
1.Primary Outcome
Title Investigate Clinical Outcomes for Intraocular Pressure After Treatment With Lotemax (Loteprednol Ophthalmic Solution) 0.5% QID in Subjects Who Have Undergone Cataract Extraction With Posterior Chamber Intraocular Implantation.
Hide Description Evaluate intraocular pressure change in mm Hg from baseline in the first 6 weeks following cataract surgery in individuals treated with Lotemax (loteprednol ophthalmic solution) 0.5% QID after cataract extraction with posterior chamber intraocular implantation.
Time Frame baseline to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati
Hide Arm/Group Description:
patients received loteprednol 0.5% suspension for 21 days following surgery in addition to pre and postoperative standard of care
Overall Number of Participants Analyzed 49
Mean (Standard Error)
Unit of Measure: mm Hg
-1.8  (1.06)
2.Secondary Outcome
Title ETDRS Letters Read Over Early Postoperative Period
Hide Description Final visual acuity at pod 42 as measured by ETDRS letters read was compared with baseline was measured for this outcome measure.
Time Frame change in ETDRS letters read baseline to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati
Hide Arm/Group Description:
patients received loteprednol 0.5% suspension for 21 days following surgery in addition to pre and postoperative standard of care
Overall Number of Participants Analyzed 41
Mean (Standard Error)
Unit of Measure: change in ETDRS letters read
8.05  (2.14)
3.Secondary Outcome
Title Cell Scores in the Early Outcome Period as Measured at 6 Weeks Post Phacoemulsification
Hide Description Cell scores at the final visit (pod 42) will be compared with baseline cells and will be measured using 1mmx1mm slit lamp beam. White cells present in the anterior chamber in a 1mm x 1mm slit lamp beam measured 3 times with the average number of cells being recorded. The grading scale was 0 (no cells/high power field), 1 (1-5 cells/high power field), 2 (6-15 cells/high power field), 3 (16-25 cells/high power field) and 4 (>25 cells/high power field). Minimal values represent less inflammation or better inflammatory control and could represent a better outcome.
Time Frame baseline to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati
Hide Arm/Group Description:
patients received loteprednol 0.5% suspension for 21 days following surgery in addition to pre and postoperative standard of care
Overall Number of Participants Analyzed 41
Mean (Standard Error)
Unit of Measure: units on a scale
0.25  (1.11)
4.Secondary Outcome
Title Flare Scores in Early Postoperative Period
Hide Description Flare scores will be measured using a 1mmx1mm slit lamp beam. Flare was assessed by looking at a 1mmx1mm slit lamp beam into the anterior chamber. Three measurements were taken and the average flare score was reported. The final outcome measure was the final flare score at 42 days compared to baseline. The grading scale was 0-4 with 0 repesenting no flare, 1mild flare, 2 moderate flare, 3 moderate severe and 4 severe flare. Minmal values represent less inflammation and could represent better inflammatory control.
Time Frame baseline to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati
Hide Arm/Group Description:
patients received loteprednol 0.5% suspension for 21 days following surgery in addition to pre and postoperative standard of care
Overall Number of Participants Analyzed 41
Mean (Standard Error)
Unit of Measure: units on a scale
0.08  (0.78)
Time Frame 6 weeks after phacoemulsification was performed
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati
Hide Arm/Group Description patients received loteprednol 0.5% suspension for 21 days following surgery in addition to pre and postoperative standard of care
All-Cause Mortality
Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati
Affected / at Risk (%) # Events
Total   0/49 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati
Affected / at Risk (%) # Events
Total   3/49 (6.12%)    
Eye disorders   
increasing ocular cell * [1]  3/49 (6.12%)  3
*
Indicates events were collected by non-systematic assessment
[1]
Patients exited from the study with increasing intraocular cells and/or pain requiring additional topical medications for inflammation. Subjective complaints and slit lamp exam were collected together at every scheduled and unscheduled visit.
Single surgeon, single site study with no randomization or masking. Fewer patients analyzed than anticipated due to competitive recruiting with similar studies.4 screen failures and 8 early terminations.
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: Melissa Morrison Toyos
Organization: Discover Vision Centers
Phone: 8164781230
EMail: mtoyos@discovervision.com
Layout table for additonal information
Responsible Party: Melissa Toyos, Toyos Clinic
ClinicalTrials.gov Identifier: NCT01344226     History of Changes
Other Study ID Numbers: MMC-2011A
First Submitted: April 27, 2011
First Posted: April 29, 2011
Results First Submitted: June 26, 2013
Results First Posted: October 22, 2018
Last Update Posted: October 22, 2018