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

This study has been completed.
Information provided by (Responsible Party):
Bausch & Lomb Incorporated Identifier:
First received: September 20, 2007
Last updated: December 7, 2011
Last verified: December 2011
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 Intervention Phase
Drug: Loteprednol etabonate 0.5% and tobramycin 0.3%
Drug: Dexamethasone 0.1% and tobramycin 0.3%
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Further study details as provided by Bausch & Lomb Incorporated:

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

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

Enrollment: 310
Study Start Date: February 2005
Study Completion Date: June 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00532961

Sponsors and Collaborators
Bausch & Lomb Incorporated
Study Director: Timothy L Comstock, DO Bausch & Lomb Incorporated
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Bausch & Lomb Incorporated Identifier: NCT00532961     History of Changes
Other Study ID Numbers: 372
Study First Received: September 20, 2007
Last Updated: December 7, 2011

Additional relevant MeSH terms:
Pathologic Processes
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Loteprednol Etabonate
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Allergic Agents
Anti-Bacterial Agents
Anti-Infective Agents processed this record on March 28, 2017