Completed

A Randomized, Multi-Center, Parallel-Group, Safety and Efficacy Study of Lotemax® Gel 0.5% and Restasis 0.05% for 12 Weeks in Subjects With Mild or Moderate Keratoconjunctivitis Sicca (Dry Eye Disease; DED)

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What is being tested

Lotemax

+ Restasis

+ Soothe® Lubricant Eye Drops

Drug
Who is being recruted

Conjunctival Diseases+6

+ Conjunctivitis

+ Corneal Diseases

Over 40 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: May 2013
See protocol details

Summary

Principal SponsorBausch & Lomb Incorporated
Last updated: August 30, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: May 17, 2013

Actual date on which the first participant was enrolled.

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.

NCT01817582
Principal SponsorBausch & Lomb Incorporated
Last updated: August 30, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

102 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 40 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Conjunctival DiseasesConjunctivitisCorneal DiseasesEye DiseasesKeratitisKeratoconjunctivitisLacrimal Apparatus DiseasesKeratoconjunctivitis SiccaDry Eye Syndromes

Criteria

3 inclusion criteria required to participate
Have a baseline intraocular pressure (IOP) measurement of greater than or equal to ( >= ) 5 millimeters of mercury (mmHg) and less than or equal to ( <= ) 22 mmHg in each eye, with or without anti-glaucoma therapy
Have been diagnosed with or treated for keratoconjunctivitis sicca (DED) within 6 months prior to screening visit (Day -14)
Have mild to moderate DED in 1 eye or both eyes at screening visit (Day -14) and randomization visit (Day 0)
13 exclusion criteria prevent from participating
Have a diagnosis of on-going ocular infection, active anterior blepharitis, moderate to severe pinguecula, Stevens-Johnson syndrome, ocular cicatricial pemphigoid, significant conjunctival scarring, ocular chemical burn, or ocular neurotrophic keratitis
Have a history of elevated IOP, a history of glaucoma, or IOP greater than ( > ) 22 mmHg in either eye at the screening visit (Day -14)
Have a history of ocular herpetic keratitis or have had active blepharitis in the 4 weeks prior to the first dose
Have a known hypersensitivity to corticosteroids, cyclosporine, fluorescein, lissamine green, topical anesthetic, or any component of either of the study drugs
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants will administer lotemax gel 0.5 % BID in both eyes (OU) for 2 weeks, then administer both lotemax gel 0.5% and restasis emulsion 0.05% BID OU for 2 weeks, then administer restasis emulsion 0.05% BID OU for 8 weeks. Participants will also receive preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).

Group II

Experimental
Participants will administer lotemax gel 0.5% BID OU for 12 weeks. Participants will also receive preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).

Group III

Active Comparator
Participants will administer restasis emulsion 0.05% BID OU for 12 weeks. Participants will also receive preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Bausch &amp; Lomb Incorporated

Irvine, United StatesOpen Bausch &amp; Lomb Incorporated in Google Maps
CompletedOne Study Center