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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date April 27, 2011
First Posted Date April 29, 2011
Results First Submitted Date June 26, 2013
Results First Posted Date October 22, 2018
Last Update Posted Date October 22, 2018
Study Start Date April 2011
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 4, 2018)
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. [ Time Frame: 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.
Original Primary Outcome Measures
 (submitted: April 28, 2011)
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. [ Time Frame: 6 weeks ]
Evaluate the Safety of treatment with Lotemax (loteprednol ophthalmic solution) 0.5% QID in subjects who have undergone cataract extraction with posterior chamber intraocular implantation.
Change History
Current Secondary Outcome Measures
 (submitted: January 4, 2018)
  • ETDRS Letters Read Over Early Postoperative Period [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical Outcomes and Evaluation of Lotemax 0.5% in Treatment of Ocular Inflammation Associated With Cataract Surgery
Official Title Clinical Outcomes and Evaluation of Lotemax (Loteprednol Ophthalmic Solution ) 0.5% QID for Treatment of Ocular Inflammation Associated With Cataract Surgery
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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Male or Female 18 years of age scheduled for unilateral cataract surgery with intraocular implant.
Condition
  • Pseudophakia
  • Inflammation
Intervention Drug: loteprednol 0.5% ophthalmic solution
Lotemax to be used QID starting day of cataract surgery and 21 days after for total of 22 days.
Other Names:
  • Lotemax
  • loteprednol
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 4, 2018)
49
Original Estimated Enrollment
 (submitted: April 28, 2011)
100
Actual Study Completion Date September 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01344226
Other Study ID Numbers MMC-2011A
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Melissa Toyos, Toyos Clinic
Study Sponsor Toyos Clinic
Collaborators Not Provided
Investigators
Principal Investigator: Melissa Toyos, MD Discover Vision Centers
PRS Account Toyos Clinic
Verification Date January 2018