Completed

Clinical Outcomes and Evaluation of Lotemax (Loteprednol Ophthalmic Solution ) 0.5% QID for Treatment of Ocular Inflammation Associated With Cataract Surgery

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Inflammation+2

+ Pathologic Processes

+ Signs and Symptoms

Over 18 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Only

Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.
Observational
Study Start: April 2011
See protocol details

Summary

Principal SponsorToyos Clinic
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2011

Actual date on which the first participant was enrolled.

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.

Official TitleClinical Outcomes and Evaluation of Lotemax (Loteprednol Ophthalmic Solution ) 0.5% QID for Treatment of Ocular Inflammation Associated With Cataract Surgery
NCT01344226
Principal SponsorToyos Clinic
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

49 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-only

These studies focus only on individuals who have a specific disease. Researchers examine patterns—often genetic or environmental—to uncover what might be linked to the condition.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

InflammationPathologic ProcessesSigns and SymptomsPathological Conditions, Signs and SymptomsPseudophakia

Criteria

9 inclusion criteria required to participate
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.

Show More Criteria

9 exclusion criteria prevent from participating
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.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Discover Vision Centers

Independence, United StatesOpen Discover Vision Centers in Google Maps
CompletedOne Study Center