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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Melissa Toyos, MD, Discover Vision Centers
ClinicalTrials.gov Identifier:
NCT01344226
First received: April 27, 2011
Last updated: May 13, 2013
Last verified: May 2013
  Purpose

Investigate the intraocular pressure(pressure inside the eye) of patients who are treated with Lotemax after undergoing cataract surgery.


Condition Intervention
Pseudophakia
Inflammation
Drug: loteprednol 0.5% ophthalmic solution

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Outcomes and Evaluation of Lotemax (Loteprednol Ophthalmic Solution ) 0.5% QID for Treatment of Ocular Inflammation Associated With Cataract Surgery

Resource links provided by NLM:


Further study details as provided by Discover Vision Centers:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • ETDRS letters read over early postoperative period [ Time Frame: baseline to 6 weeks ] [ Designated as safety issue: No ]
    ETDRS letters read will be assessed at baseline and at pod1, pod7, pod21 and pod42. Acuities will be

  • cell scores in early postoperative period [ Time Frame: baseline to 6 weeks ] [ Designated as safety issue: No ]
    Cell scores will be measured using 1mmx1mm slit lamp beam at baseline, pod1, pod7,pod21 and pod42.

  • Flare scores in early postoperative period [ Time Frame: baseline to 6 weeks ] [ Designated as safety issue: No ]
    Flare scores will be measured using a 1mmx1mm slit lamp beam at baseline, pod1, pod7, and pod42


Estimated Enrollment: 100
Study Start Date: April 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Male or Female 18 years of age scheduled for unilateral cataract surgery with intraocular implant.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01344226

Locations
United States, Missouri
Discover Vision Centers
Independence, Missouri, United States, 64055
Sponsors and Collaborators
Discover Vision Centers
Investigators
Principal Investigator: Melissa Cable, MD Discover Vision Centers
  More Information

Additional Information:
No publications provided

Responsible Party: Melissa Toyos, MD, Principal Investigator, Discover Vision Centers
ClinicalTrials.gov Identifier: NCT01344226     History of Changes
Other Study ID Numbers: MMC-2011A
Study First Received: April 27, 2011
Last Updated: May 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Discover Vision Centers:
steroid responder

Additional relevant MeSH terms:
Inflammation
Pseudophakia
Cataract
Pathologic Processes
Signs and Symptoms
Lens Diseases
Eye Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Loteprednol etabonate
Therapeutic Uses
Pharmacologic Actions
Anti-Allergic Agents

ClinicalTrials.gov processed this record on August 20, 2014