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

NCT ID: NCT01817582

Last Updated: 2019-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-17
• Study Completion Date: 2014-01-10

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Lotemax Gel 0.5% and Restasis 0.05%

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 Type: EXPERIMENTAL

Lotemax

Intervention Type: DRUG

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

Restasis

Intervention Type: DRUG

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

Soothe® Lubricant Eye Drops

Intervention Type: DRUG

Lotemax Gel 0.5%

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 Type: EXPERIMENTAL

Lotemax

Intervention Type: DRUG

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

Soothe® Lubricant Eye Drops

Intervention Type: DRUG

Restasis 0.05%

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).

Group Type: ACTIVE_COMPARATOR

Restasis

Intervention Type: DRUG

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

Soothe® Lubricant Eye Drops

Intervention Type: DRUG

Interventions

Lotemax

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

Intervention Type: DRUG

Restasis

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

Intervention Type: DRUG

Soothe® Lubricant Eye Drops

Intervention Type: DRUG

Other Intervention Names

loteprednol etabonate ophthalmic gel 0.5%; cyclosporine ophthalmic emulsion 0.05%; Soothe lubricant eye drops will be administered as needed.

Eligibility Criteria

Inclusion Criteria

• Have been diagnosed with or treated for keratoconjunctivitis sicca (DED) within 6 months prior to screening visit (Day -14).
• 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 mild to moderate DED in 1 eye or both eyes at screening visit (Day -14) and randomization visit (Day 0).

Exclusion Criteria

• Have a known hypersensitivity to corticosteroids, cyclosporine, fluorescein, lissamine green, topical anesthetic, or any component of either of the study drugs.
• Have severe DED.
• Have corneal erosive disease or other conditions suggestive of extensive damage of the cornea.
• 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 had penetrating intraocular surgery in the past 12 months or require penetrating intraocular surgery during the study.
• Have had eyelid surgery within the 6 months prior to Visit 1 (Day -14) or have DED secondary to surgery.
• Have visible evidence of anterior lid Demodex spp. infection or infestation.
• Have had corneal refractive surgery or corneal transplantation.
• Have congenitally absent lacrimal or meibomian glands or have any obstructive disease of the lacrimal glands, sarcoidosis, or any other lacrimal gland deficiency.
• 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 any serious systemic disease or uncontrolled medical condition that in the judgment of the investigator could confound study assessments or limit compliance.
• Have a history of ocular herpetic keratitis or have had active blepharitis in the 4 weeks prior to the first dose.
• Have had ocular surgery (including laser) within 6 months prior to the first Treatment Period, or plan or require ocular surgery during the study. Neodymiumdoped:yttrium aluminum garnet (Nd:YAG) laser posterior capsulotomy is allowed.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Synteract, Inc.

INDUSTRY

Sponsor Role: collaborator

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan Harris

Role: STUDY_DIRECTOR

Bausch Health Americas, Inc.

Locations

Bausch & Lomb Incorporated

Irvine, California, United States

Countries

United States

Other Identifiers

813

Identifier Type: -

Identifier Source: org_study_id