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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00532961
First received: September 20, 2007
Last updated: December 7, 2011
Last verified: December 2011
  Purpose

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
Inflammation
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 ] [ Designated as safety issue: No ]
  • Intraocular pressure measurements [ Time Frame: Day 1, 3, 8,15, 22 and 29 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of safety [ Time Frame: Througout 28-day study ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00532961

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

No publications provided by Bausch & Lomb Incorporated

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00532961     History of Changes
Other Study ID Numbers: 372
Study First Received: September 20, 2007
Last Updated: December 7, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Inflammation
Pathologic Processes
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Loteprednol etabonate
Tobramycin
Anti-Allergic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014