Lotemax® Gel 0.5% and Restasis 0.05% in Subjects With Mild or Moderate Keratoconjunctivitis Sicca

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01817582
First received: March 21, 2013
Last updated: November 22, 2013
Last verified: November 2013
  Purpose

This study is being conducted to investigate the safety, comfort, and tolerability of 3 treatments: Lotemax® gel 0.5% administered twice daily (BID)with or without 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.


Condition Intervention Phase
Keratoconjunctivitis Sicca
Drug: Lotemax Gel + Restasis
Drug: Lotemax Gel
Drug: Restasis
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Corneal fluorescein staining [ Time Frame: Mean change from baseline to Visit 4(day 28) ] [ Designated as safety issue: No ]
  • Ocular Surface Disease Index [ Time Frame: Visit 4(day 28) ] [ Designated as safety issue: No ]
    Ocular Surface Disease Index (OSDI) Questionnaire to measure severity of dry eye. Total score through Visit 4.


Secondary Outcome Measures:
  • Worst Symptom Selection and Scoring [ Time Frame: Visit 2 (Day 0) - Visit 5 (Day 84) ] [ Designated as safety issue: No ]
    Participants will rate the severity of dry eye symptoms at on a 5-point grading scale for each of 8 symptoms and will then select their most bothersome symptom.

  • Ocular Comfort [ Time Frame: Visit 2 (Day 0) - Visit 5 (Day 84) ] [ Designated as safety issue: No ]
    Subject self-assessment questionnaire of ocular comfort after drug instillation. Graded on a 4 point scale where 0=comfortable and 3=severly uncomfortable

  • Tear Osmolarity [ Time Frame: Visit 2 (day 0) - Visit 5 (day 84) ] [ Designated as safety issue: No ]
    50nL tear sample collected from each eye. Tear osmolarity for each sample will be read with the TearLab instrument in milliosmoles. Average values will be calculated.

  • Tear film break-up time (TFBUT) [ Time Frame: Visit 2 (day 0) - Visit 5 ( day 84) ] [ Designated as safety issue: No ]
    A measure of eye dryness; the cornea and conjunctiva are stained with fluorescein and tear film breakup time is determined.

  • Fluorescein Staining [ Time Frame: Visit 2 (day 0) - Visit 5 (day 84) ] [ Designated as safety issue: No ]
    Corneal total fluorescein stain scoring for punctate keratopathy

  • Lissamine green (LG) stain [ Time Frame: Visit 2 (day 0) - Visit 5 (day 84) ] [ Designated as safety issue: No ]
    LG stain is for monitoring eye dryness in conjunctival tissue.

  • Dry eye signs and symptoms [ Time Frame: Visit 2 (day 0) - Visit 5 (day 84) ] [ Designated as safety issue: No ]
    Subjects and Investigators will grade the overall improvement for change from baseline(Visit 2) in dry eye signs and symptoms for each subject at Visit 5

  • Eye Redness [ Time Frame: Visit 2 (day 0) - Visit 5 (day 84) ] [ Designated as safety issue: No ]
    Degree of eye redness on a 4-point grading scale. Where 0=none and 3=severe

  • Anesthetized Schirmer's Test [ Time Frame: Visit 1 (day -14) and Visit 6 (day 84) ] [ Designated as safety issue: No ]
    The Schirmer's test is a measure of the tonic secretion of the aqueous component of tears. The Schirmer's test will be conducted for both eyes.

  • Global Improvement in Dry Eye [ Time Frame: Visit 2 (day 0) and Visit 5 (day 84) ] [ Designated as safety issue: No ]
    Subjects and Investigators will grade the overall global improvement for change from baseline in dry eye signs and symptoms.


Estimated Enrollment: 100
Study Start Date: May 2013
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lotemax gel + Restasis
Loteprednol etabonate ophthalmic gel 0.5% and cyclosporine ophthalmic emulsion 0.05% administered one drop of each medication into each eye, two times a day (BID) for 12-weeks.
Drug: Lotemax Gel + Restasis
Other Names:
  • loteprednol etabonate gel 0.5%
  • cyclosporine ophthalmic emulsion 0.05%
Experimental: Lotemax Gel
Loteprednol etabonate ophthalmic gel 0.5% administered one drop of medication into each eye, two times a day (BID) for 12-weeks.
Drug: Lotemax Gel
Other Name: loteprednol etabonate 0.5%
Experimental: Restasis
Cyclosporine ophthalmic emulsion 0.05% administered one drop of medication into each eye, two times a day (BID) for 12-weeks.
Drug: Restasis
Other Name: cyclosporine ophthalmic emulsion 0.05%

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have been diagnosed with or treated for keratoconjunctivitis sicca (dry eye disease[DED]) within 6 months prior to Visit 1.
  • Have a baseline (Visit 2) Intraocular pressure (IOP) measurement of ≥ 5 mmHg and ≤ 22 mmHg in each eye, with or without anti-glaucoma therapy.
  • Have mild to moderate DED in one eye or both eyes at Visit 1 and Visit 2.

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 > 22 mm Hg in either eye at the screening visit (Visit 1).
  • 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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01817582

Locations
United States, California
Bausch & Lomb Incorporated
Irvine, California, United States, 92618
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Jon I Williams, PhD Bausch & Lomb Incorporated
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01817582     History of Changes
Other Study ID Numbers: 813
Study First Received: March 21, 2013
Last Updated: November 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bausch & Lomb Incorporated:
Dry Eye Disease

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Cyclosporins
Cyclosporine
Loteprednol etabonate
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on April 14, 2014