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

NCT01344226 | Completed Results DMC

• 1 other identifier: MMC-2011A
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pseudophakia; Inflammation

Keywords

steroid responder

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• ETDRS Letters Read Over Early Postoperative Period

  change in ETDRS letters read baseline to 6 weeks

• Cell Scores in the Early Outcome Period as Measured at 6 Weeks Post Phacoemulsification

  baseline to 6 weeks

• Flare Scores in Early Postoperative Period

  baseline to 6 weeks

Interventions

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.

Also known as: Lotemax, loteprednol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Male or Female 18 years of age scheduled for unilateral cataract surgery (phacoemulsification or extracapsular) with posterior chamber intraocular lens implantation.
• Agree not to have any other ocular surgery in the study or fellow eye for duration of study.
• Have a BCVA of 20/200 or better in either eye.
• Willing/able to return for all required study visits.
• Willing/able to follow instructions from the study investigator and their staff.
• Able to self-administer test article (or have a caregiver available to instill all doses of test article).
• 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.
• Have read, understood, and signed the informed consent document approved by Sterling Institutional Review Board.
• 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).

You may not qualify if:

• 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.).
• Have a known hypersensitivity to non-steroidal or steroidal anti-inflammatory drugs (NSAIDs).
• 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.
• 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.
• 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.
• Have uncontrolled glaucoma or IOP \>/= 27mmHg.
• 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.
• Are pregnant or nursing.
• Have participated in any other study of an investigational drug or device within 30 days prior to randomization.

Sponsors & Collaborators

• Toyos Clinic: lead

Study Sites (1)

Discover Vision Centers

Independence, Missouri, 64055, United States

Location

Related Links

• Click on "Current Studies"

MeSH Terms

Conditions

Pseudophakia; Inflammation

Interventions

Loteprednol Etabonate; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Limitations and Caveats

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.

Results Point of Contact

• Title: Melissa Morrison Toyos
• Organization: Discover Vision Centers

mtoyos@discovervision.com

8164781230

Study Officials

• Melissa Toyos, MD

  Discover Vision Centers

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 27, 2011
• First Posted: April 29, 2011
• Study Start: April 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: October 22, 2018
• Results First Posted: October 22, 2018

Record last verified: 2018-01

Locations

US (1)