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Investigate the intraocular pressure(pressure inside the eye) of patients who are treated with Lotemax after undergoing cataract surgery.
This is a single-center study to evaluate the clinical outcomes of Lotemax 0.5% for the treatment of Ocular inflammation associated with cataract surgery. Subjects will be screened from one to 21 days prior to initiation of dosing with the test article. Subjects who sign the informed consent document and meet all inclusion/exclusion criteria will be eligible to participate in this study. Subjects will instill one drop of Lotemax into the study (operative) eye QID for a maximum of 22 days. Dosing with test article will begin the day of surgery and for 21 days after surgery. Subjects will be seen for evaluation on Days 1, 7±1, and 21 ± 2 following surgery. Subjects will be seen for a follow-up visit on Day 42 ± 3 following surgery, about 21 days after their last dose of test article.
In addition to the test article regimen, subjects will receive Vigamox TID 3 days prior to surgery. Patients will receive one drop of Timoptic XE 0.5%, Zymaxid on the day of surgery. Postoperatively, patients will receive Vigamox TID for ten days and Bromday QD for 3 weeks.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| loteprednol 0.5% ophthalmic solution | Drug | Lotemax to be used QID starting day of cataract surgery and 21 days after for total of 22 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | baseline to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| ETDRS Letters Read Over Early Postoperative Period | Final visual acuity at pod 42 as measured by ETDRS letters read was compared with baseline was measured for this outcome measure. | change in ETDRS letters read baseline to 6 weeks |
| Cell Scores in the Early Outcome Period as Measured at 6 Weeks Post Phacoemulsification |
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Inclusion Criteria:
Exclusion Criteria:
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Male or Female 18 years of age scheduled for unilateral cataract surgery with intraocular implant.
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Toyos, MD | Discover Vision Centers | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Discover Vision Centers | Independence | Missouri | 64055 | United States |
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| Label | URL |
|---|---|
| Click on "Current Studies" | View source |
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patients had to be off of steroids for 14 days with no depot steroid injection for 30 days
Patients in one location of one surgeon's clinic about to undergo cataract surgery were recruited from July 2011 to May 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati | patients received loteprednol 0.5% suspension for 21 days following surgery in addition to pre and postoperative standard of care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | Standard Error | mm Hg | baseline to 6 weeks |
|
6 weeks after phacoemulsification was performed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati | patients received loteprednol 0.5% suspension for 21 days following surgery in addition to pre and postoperative standard of care |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| increasing ocular cell | Eye disorders | Non-systematic Assessment | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melissa Morrison Toyos | Discover Vision Centers | 8164781230 | mtoyos@discovervision.com |
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| ID | Term |
|---|---|
| D019591 | Pseudophakia |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000069559 | Loteprednol Etabonate |
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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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. |
| baseline to 6 weeks |
| Flare Scores in Early Postoperative Period | 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. | baseline to 6 weeks |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | ETDRS Letters Read Over Early Postoperative Period | Final visual acuity at pod 42 as measured by ETDRS letters read was compared with baseline was measured for this outcome measure. | Posted | Mean | Standard Error | change in ETDRS letters read | change in ETDRS letters read baseline to 6 weeks |
|
|
|
| Secondary | Cell Scores in the Early Outcome Period as Measured at 6 Weeks Post Phacoemulsification | 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. | Posted | Mean | Standard Error | units on a scale | baseline to 6 weeks |
|
|
|
| Secondary | Flare Scores in Early Postoperative Period | 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. | Posted | Mean | Standard Error | units on a scale | baseline to 6 weeks |
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| 0 |
| 49 |
| 3 |
| 49 |
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| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |