Inflammation, Pseudophakia
Conditions
Keywords
steroid responder
Brief summary
Investigate the intraocular pressure(pressure inside the eye) of patients who are treated with Lotemax after undergoing cataract surgery.
Detailed description
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.
Interventions
DRUGloteprednol 0.5% ophthalmic solution
Lotemax to be used QID starting day of cataract surgery and 21 days after for total of 22 days.
Sponsors
Toyos Clinic
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or Female 18 years of age scheduled for unilateral cataract surgery (phacoemulsification or extracapsular) with posterior chamber intraocular lens implantation. 2. Agree not to have any other ocular surgery in the study or fellow eye for duration of study. 3. Have a BCVA of 20/200 or better in either eye. 4. Willing/able to return for all required study visits. 5. Willing/able to follow instructions from the study investigator and their staff. 6. Able to self-administer test article (or have a caregiver available to instill all doses of test article). 7. If woman capable of becoming pregnant, agree to have urine pregnancy test(must be negative) at agree to use a medically acceptable form of birth control during study and for at least one week prior to and after completion of the study. 8. Have read, understood, and signed the informed consent document approved by Sterling Institutional Review Board. 9. Have IOP ≥ 5mmHg and ≤ 22mmHg, (in study eye) with or without anti-glaucoma therapy at the pre-operative screening visit (if \> 22mmHg, adjust following pachymetry).
Exclusion criteria
1. Have known hypersensitivity to Lotemax or to any component of the test article (including procedural medications such as anesthetic and/or fluorescein drops, dilating drops, etc.). 2. Have a known hypersensitivity to non-steroidal or steroidal anti-inflammatory drugs (NSAIDs). 3. Have intraocular inflammation (i.e. cells or flare in the anterior chamber as measured on slit lamp exam) in the study eye at the screening visit. 4. Have a known blood dyscrasia or bone marrow suppression, a diagnosis of uncontrolled/unstable peptic ulcer disease, inflammatory bowel disease, or ulcerative colitis, or any uncontrolled/unstable pulmonary, cardiac, vascular, autoimmune, hepatic, renal, or central nervous system disease. 5. Have used ocular, topical, or systemic steroids within 14 days or depot steroid 30 days prior to initiation of dosing with the test article or throughout the duration of the study. Note: use of an opioid during surgery (e.g., fentanyl) is allowed. 6. Have uncontrolled glaucoma or IOP \>/= 27mmHg. 7. Have active corneal pathology noted in the study eye at the screening visit. Active corneal pathology is defined as corneal pathology that is non-stable, or greater than mild, or will compromise assessment of the safety or efficacy of treatment. 8. Are pregnant or nursing. 9. Have participated in any other study of an investigational drug or device within 30 days prior to randomization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | baseline to 6 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ETDRS Letters Read Over Early Postoperative Period | change in ETDRS letters read baseline to 6 weeks | Final visual acuity at pod 42 as measured by ETDRS letters read was compared with baseline was measured for this outcome measure. |
| Cell Scores in the Early Outcome Period as Measured at 6 Weeks Post Phacoemulsification | baseline to 6 weeks | 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. |
| Flare Scores in Early Postoperative Period | baseline to 6 weeks | 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. |
Countries
United States
Participant flow
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
Participants by arm
| Arm | Count |
|---|---|
| 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 | 49 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 3 |
| Overall Study | Protocol Violation | 2 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 35 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Age, Continuous | 68.93 years STANDARD_DEVIATION 9.61 |
| Region of Enrollment United States | 49 participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 49 |
| serious Total, serious adverse events | 0 / 49 |
Outcome results
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.
Time frame: baseline to 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati | 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. | -1.8 mm Hg | Standard Error 1.06 |
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.
Time frame: baseline to 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati | Cell Scores in the Early Outcome Period as Measured at 6 Weeks Post Phacoemulsification | 0.25 units on a scale | Standard Error 1.11 |
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.
Time frame: change in ETDRS letters read baseline to 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati | ETDRS Letters Read Over Early Postoperative Period | 8.05 change in ETDRS letters read | Standard Error 2.14 |
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.
Time frame: baseline to 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati | Flare Scores in Early Postoperative Period | 0.08 units on a scale | Standard Error 0.78 |