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

NCT ID: NCT00532961

Last Updated: 2011-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

310 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2005-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Zylet

Zylet (loteprednol etabonate and tobramycin)

Group Type EXPERIMENTAL

Loteprednol etabonate 0.5% and tobramycin 0.3%

Intervention Type 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

Tobradex

TobraDex (dexamethasone and tobramycin)

Group Type ACTIVE_COMPARATOR

Dexamethasone 0.1% and tobramycin 0.3%

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Zylet TobraDex

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Timothy L Comstock, DO

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

References

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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.

Reference Type DERIVED
PMID: 18577309 (View on PubMed)

Other Identifiers

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372

Identifier Type: -

Identifier Source: org_study_id