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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00532961

Enrollment

310

Registered

2007-09-21

Start date

2005-02-28

Completion date

2005-06-30

Last updated

2011-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation

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.

Interventions

DRUGLoteprednol 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

DRUGDexamethasone 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Ocular comfort/tolerability	Day 1, 3, 8, 15, 22 and 29
Intraocular pressure measurements	Day 1, 3, 8,15, 22 and 29

Secondary

Measure	Time frame
Assessment of safety	Througout 28-day study

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026