Clinical trial NCT01817582: Lotemax® Gel 0.5% and Restasis 0.05% in Participants With Mild or Moderate Keratoconjunctivitis Sicca (Dry Eye Disease)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Keratoconjunctivitis Sicca
Keywords: Dry Eye Disease
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
Collaborators: name: Synteract, Inc.
First posted: 2013-03-25
Enrollment: 102
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change From Baseline in Corneal Total Fluorescein Staining Score at for the Study Eye at Week 4
timeFrame: Baseline (Day 0), Week 4
measure: Change From Baseline in Mean Ocular Surface Disease Index (OSDI) Questionnaire Total Score at Week 4
timeFrame: Baseline, Week 4
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: Baseline up to Week 13
measure: Mean Grade for Participant-Reported Post-Dosing Ocular Comfort Values
timeFrame: Week 12
Secondary outcomes:
measure: Change From Baseline in Mean OSDI Questionnaire Total Score and Individual Question Scores at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Mean Corneal Total Fluorescein Staining Score for the Study Eye and Averaged for Both Eyes at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Mean Value of Participant Worst Eye Score for Each Symptom (Including the Pre-Specified Worst Symptom) in the List of Possible Worst Symptoms at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Mean Total Combined Lissamine Green (LG) Staining (Nasal Plus Temporal Conjunctival) Score for the Study Eye and Averaged for Both Eyes at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Mean Tear Osmolarity of Participant Worst Eye Value at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Mean Tear Osmolarity Between Two Eyes of Participant at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Mean Eye Comfort Index Questionnaire Total Score and Individual Question Scores at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Mean Eye Dryness Questionnaire Total and Individual Question Scores at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Mean Tear Film Breakup Time (TFBUT) (by Fluorescein Staining) of the Study Eye and Averaged for Both Eyes of a Participant at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Mean Non-Invasive Keratographic Tear Film Breakup Time (NIKBUT) of the Study Eye and Averaged for Both Eyes of a Participant at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Mean Anesthetized Schirmer's Test Values (Distance of Strips Wetting) in the Study Eye and Averaged for Both Eyes of a Participant at Week 13
timeFrame: Baseline, Week 13
measure: Averaged Daily Soothe Lubricant Eye Drops Usage
timeFrame: Baseline up to Week 12
measure: Number of Participants With Overall Change From Baseline in Dry Symptoms at Week 12 as Assessed Independently by Investigators and Participants
timeFrame: Baseline, Week 12
measure: Change From Baseline in Ocular Redness Score for Study Eye and Averaged for Both Eyes at Week 12, as Assessed by Investigator
timeFrame: Baseline, Week 12
measure: Change From Baseline in Non-Invasive Keratographic Limbal and Bulbar Ocular Redness Scores for Study Eye and Averaged for Both Eyes at Week 12, as Assessed by Investigator
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Bausch & Lomb Incorporated
state: California
Study officials:
affiliation: Bausch Health Americas, Inc.
name: Susan Harris
role: STUDY_DIRECTOR
References: