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Ocular Tissue Levels of 1.5% Levofloxacin Ophthalmic Solution Compared to an Active Comparator

Information source: Santen Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cataract

Intervention: 1.5% levofloxacin ophthalmic solution (Drug); 0.5% moxifloxacin hydrochloride ophthalmic solution (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Santen Inc.

Summary

Compare ocular tissue levels following topical ocular instillation of 1. 5% levofloxacin ophthalmic solution or an active comparator in subjects undergoing cataract surgery.

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Primary outcome: Concentration of levofloxacin and active control in the aqueous humor

Secondary outcome: Adverse Events

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Capable of instilling eye drop

- Scheduled for cataract surgery with intraocular lens (IOL) implantation

- Be medically cleared for surgery

- Women must be postmenopausal (for at least 1 year), surgically sterile, abstinent,

or, if sexually active, be practicing an effective method of birth control before entry, and must agree to continue to use the same method of contraception throughout the study

- Women of childbearing potential must have a negative urine pregnancy test at

screening.

- Willing to adhere to the prohibitions and restrictions specified in this protocol.

- Subjects (or his/her legally acceptable representative) must have signed an informed

consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. Exclusion Criteria:

- Known allergy or other contraindication to the test article(s) or their components.

- Presence of any abnormality or significant illness in the eye that in the

investigator's opinion could affect the subject's health or the study parameters.

- History of or presence of any corneal pathology or disease

- Presence of an active ocular infection (bacterial, viral or fungal), or positive

history of ocular herpetic infection.

- History of severe dry eye syndrome.

- History or evidence of previous ocular surgery in the operative eye.

- History of any significant illness that could be expected to interfere with the study

parameters.

- Use of disallowed therapies (systemic or topical):

- Fluoroquinolone anti-infective agents (systemic or topical) within 2 weeks of

Visit 1 or anytime after Visit 1 for the duration of the study;

- Topical ophthalmic preparations (including tear substitutes and rewetting

drops), within 1 week of Visit 1 or anytime after Visit 1 for the duration of the study (other than the study medication as restricted above), with the exception of non-steroidal topical ophthalmic drops

- Use of contact lenses in the 2 weeks prior to the study and for the duration of the

study.

- Received an experimental drug or used an experimental medical device within 30 days

before the planned start of treatment.

- Pregnant or breast-feeding.

- Any condition that, in the opinion of the investigator, would compromise the

well-being of the subject or the study.

- Employees of the investigator or study center, with direct involvement in the

proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.

Locations and Contacts

Bucci Laser Vision & Ambulatory Surgery Center, Wilkes-Barre, Pennsylvania 18702, United States
Additional Information

Starting date: February 2008
Last updated: February 4, 2009

Page last updated: August 23, 2015

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