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Ocular Tolerance and Intraocular Pressure (IOP) Effects of Zylet Versus Tobradex

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: NCT00532961
Recruitment Status : Completed
First Posted : September 21, 2007
Last Update Posted : December 8, 2011
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Brief Summary:
Phase IV, randomized, double-masked, parallel-group clinical trial comparing the ocular tolerability and steroid-induced intraocular pressure (IOP) effects of Zylet wth that of TobraDex in healthy volunteers, when either product was administered QID (at approximately 4-hour intervals) for 28 days.

Condition or disease Intervention/treatment Phase
Inflammation Drug: Loteprednol etabonate 0.5% and tobramycin 0.3% Drug: Dexamethasone 0.1% and tobramycin 0.3% Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 310 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-masked, Parallel Comparison of Ocular Tolerance and IOP Effects of Zylet vs TobraDex Administered Four Times Daily for Four Weeks in Healthy Volunteers
Study Start Date : February 2005
Actual Primary Completion Date : April 2005
Actual Study Completion Date : June 2005

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Zylet
Zylet (loteprednol etabonate and tobramycin)
Drug: Loteprednol etabonate 0.5% and tobramycin 0.3%
ophthalmic suspension, four times daily during the day at roughly 4 hour intervals(1-2 drops per eye)for a total of 28 days
Other Name: Zylet

Active Comparator: Tobradex
TobraDex (dexamethasone and tobramycin)
Drug: Dexamethasone 0.1% and tobramycin 0.3%
ophthalmic suspension, four times daily during the day at roughly 4 hour intervals (1-2 drops/eye) for a total of 28 days.
Other Name: TobraDex




Primary Outcome Measures :
  1. Ocular comfort/tolerability [ Time Frame: Day 1, 3, 8, 15, 22 and 29 ]
  2. Intraocular pressure measurements [ Time Frame: Day 1, 3, 8,15, 22 and 29 ]

Secondary Outcome Measures :
  1. Assessment of safety [ Time Frame: Througout 28-day study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • in good general health based on investigator judgment
  • able and willing to follow instructions, provide informed consent, make the required study visits, and use an electronic patient diary during the study
  • possessing a best corrected visual acuity of at least 20/40 in each eye
  • for females, using reliable contraception and a negative urine pregnancy test prior to study entry

Exclusion Criteria:

  • contact lenses worn within 30 days prior to enrollment or during study period
  • known hypersensitivity to study medication or any component
  • presence of significant ocular or systemic disease that might interfere with the interpretation of the results
  • a need for administration of chronic topical ocular or systemic medications of any kind during the study.
  • participation in an opthalmic drug or device research study within 30 days prior to entry

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00532961


Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
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Study Director: Timothy L Comstock, DO Bausch & Lomb Incorporated
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00532961    
Other Study ID Numbers: 372
First Posted: September 21, 2007    Key Record Dates
Last Update Posted: December 8, 2011
Last Verified: December 2011
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes
Loteprednol Etabonate
Tobramycin
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Allergic Agents