MedTrace Logo

Lotemax® Gel 0.5% and Restasis 0.05% in Participants With Mild or Moderate Keratoconjunctivitis Sicca (Dry Eye Disease)

NCT01817582 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2019-08-30

Study results available
· View outcomes & findings →

Summary

This study is being conducted to investigate the safety, comfort, and tolerability of 3 treatments: loteprednol etabonate ophthalmic (Lotemax®) gel 0.5 percent (%) administered twice daily (BID) with or without cyclosporine ophthalmic emulsion (Restasis) 0.05% administered BID, and Restasis 0.05% treatment alone for 12 weeks and at a follow-up safety visit 1 week post-treatment. This study will also investigate the relative efficacy of Lotemax gel 0.5% administered BID with or without Restasis 0.05% treatment administered BID and of Restasis 0.05% treatment alone for the reduction of clinical signs or symptoms of keratoconjunctivitis sicca (DED) over the first 4 weeks of a 12-week treatment period and at the end of a 12-week treatment period.

Conditions

  • Keratoconjunctivitis Sicca

Interventions

DRUG

Lotemax

Lotemax gel will be administered as per the dose and schedule specified in the arms.

DRUG

Restasis

Restasis emulsion will be administered as per the dose and schedule specified in the arms.

DRUG

Soothe® Lubricant Eye Drops

Sponsors & Collaborators

  • Synteract, Inc.

    collaborator INDUSTRY

  • Bausch & Lomb Incorporated

    lead INDUSTRY

Principal Investigators

  • Susan Harris · Bausch Health Americas, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-17
Primary Completion
2014-01-10
Completion
2014-01-10

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01817582 on ClinicalTrials.gov