NCT00532961

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
310

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2005

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 2007

Completed
Last Updated

December 8, 2011

Status Verified

December 1, 2011

Enrollment Period

2 months

First QC Date

September 20, 2007

Last Update Submit

December 7, 2011

Conditions

Inflammation

Outcome Measures

Primary Outcomes (2)

  • Ocular comfort/tolerability

    Day 1, 3, 8, 15, 22 and 29

  • Intraocular pressure measurements

    Day 1, 3, 8,15, 22 and 29

Secondary Outcomes (1)

  • Assessment of safety

    Througout 28-day study

Study Arms (2)

Zylet

EXPERIMENTAL

Zylet (loteprednol etabonate and tobramycin)

Drug: Loteprednol etabonate 0.5% and tobramycin 0.3%

Tobradex

ACTIVE COMPARATOR

TobraDex (dexamethasone and tobramycin)

Drug: Dexamethasone 0.1% and tobramycin 0.3%

Interventions

Loteprednol etabonate 0.5% and tobramycin 0.3%DRUG

ophthalmic suspension, four times daily during the day at roughly 4 hour intervals(1-2 drops per eye)for a total of 28 days

Also known as: Zylet
Zylet
Dexamethasone 0.1% and tobramycin 0.3%DRUG

ophthalmic suspension, four times daily during the day at roughly 4 hour intervals (1-2 drops/eye) for a total of 28 days.

Also known as: TobraDex
Tobradex

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Bartlett JD, Holland EJ, Usner DW, Paterno MR, Comstock TL. Tolerability of loteprednol/tobramycin versus dexamethasone/tobramycin in healthy volunteers: results of a 4-week, randomized, double-masked, parallel-group study. Curr Med Res Opin. 2008 Aug;24(8):2219-27. doi: 10.1185/03007990802231981. Epub 2008 Jun 23.

    PMID: 18577309DERIVED

MeSH Terms

Conditions

Inflammation

Interventions

Loteprednol EtabonateDexamethasoneTobramycin, Dexamethasone Drug Combination

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsPregnadienetriolsPregnadienesPregnanesSteroids, FluorinatedTobramycinNebramycinKanamycinAminoglycosidesGlycosidesCarbohydratesDrug CombinationsPharmaceutical Preparations

Study Officials

  • Timothy L Comstock, DO

    Bausch & Lomb Incorporated

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2007

First Posted

September 21, 2007

Study Start

February 1, 2005

Primary Completion

April 1, 2005

Study Completion

June 1, 2005

Last Updated

December 8, 2011

Record last verified: 2011-12