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Corticosteroid

Loteprednol etabonate and tobramycin for Dry Eye Syndrome

Phase 4
Waitlist Available
Research Sponsored by Bausch & Lomb Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 15 days
Awards & highlights
All Individual Drugs Already Approved
Drug Has Already Been Approved
Pivotal Trial

Summary

The objective of this study is to evaluate the safety and effectiveness of Zylet in comparison with Lotemax, Tobramycin and the vehicle of Zylet for the treatment of blepharoconjunctivitis in pediatric subjects.

Eligible Conditions
  • Dry Eye Syndrome
  • Pink Eye

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 15 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 15 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline in the Total Blepharoconjunctivitis Grade.
Secondary study objectives
Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 2
Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 3

Side effects data

From 2010 Phase 4 trial • 137 Patients • NCT00705159
6%
Bronchiolitis
6%
Cough
3%
Respiratory distress
100%
80%
60%
40%
20%
0%
Study treatment Arm
Loteprednol Etabonate and Tobramycin
Loteprednol Etabonate
Tobramycin
Vehicle

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Loteprednol etabonate and tobramycinExperimental Treatment1 Intervention
Drug: Zylet (loteprednol etabonate and tobramycin)
Group II: Loteprednol etabonateActive Control1 Intervention
Drug: Lotemax (loteprednol etabonate)
Group III: TobramycinActive Control1 Intervention
Drug: Tobramycin
Group IV: VehiclePlacebo Group1 Intervention
Vehicle of Zylet
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tobramycin
FDA approved

Find a Location

Who is running the clinical trial?

Bausch & Lomb IncorporatedLead Sponsor
257 Previous Clinical Trials
58,093 Total Patients Enrolled
~8 spots leftby Nov 2025
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