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

NCT01817582 | Completed Phase 2 Results

• 1 other identifier: 813
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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

Keywords

Dry Eye Disease

Outcome Measures

Primary Outcomes (4)

• Change From Baseline in Corneal Total Fluorescein Staining Score at for the Study Eye at Week 4

  Fluorescein Corneal Staining indicates the damage to the corneal epithelium (corneal epitheliopathy). Punctate corneal staining with fluorescein was evaluated and graded according to the National Eye Institute (NEI) grading method. The cornea was divided into 5 regions: central, superior, inferior, nasal and temporal. Each of these 5 regions was graded from scores 0 to 3, where 0 indicated no staining (absent) and 3 maximal staining (severe damage). The total score was the sum of all these regions, ranged from 0 (absence of corneal epitheliopathy) to 15 (severe corneal epitheliopathy).

  Baseline (Day 0), Week 4

• Change From Baseline in Mean Ocular Surface Disease Index (OSDI) Questionnaire Total Score at Week 4

  OSDI is a 12-item questionnaire developed to assess severity of DED. There are 3 question types: "Have you experienced any of following (light sensitivity, eye feel gritty, sore eyes, blurred vision, and poor vision) during last week?"(items 1-5); "Have problems with your eyes limited you in performing any of following (reading, driving at night, working with computer, and watching TV) during last week?" (items 6-9); and "Have your eyes felt uncomfortable in any of following situations (windy, low humidity, air conditioned) during the last week?" (items 10-12). Response of each of these questions were graded on a scale (that relate to the frequency of ocular surface disease effects) of 0 (none of the time) to 4 (all of the time).Total OSDI score was calculated using following formula: OSDI=(\[sum of scores for all questions answered\] × 100)/(\[total number of questions answered\] \* 4). Total OSDI score ranged from 0 to 100, with higher scores representing greater disability.

  Baseline, Week 4

• Percentage of Participants With Adverse Events (AEs)

  An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious AEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

  Baseline up to Week 13

• Mean Grade for Participant-Reported Post-Dosing Ocular Comfort Values

  Participants scored their degree of comfort with their assigned study drug on a 4-point scale (0-3 units) within 5 minutes after instillation of study drug. Comfort grade 0 indicated comfortable, discomfort absent; 1 indicated generally comfortable, mild discomfort; 2 indicated some discomfort but tolerable, moderate discomfort; 3 indicated severely uncomfortable or intolerable. The mean global ocular comfort grade was reported.

  Week 12

Secondary Outcomes (15)

• Change From Baseline in Mean OSDI Questionnaire Total Score and Individual Question Scores at Week 12

  Baseline, Week 12

• Change From Baseline in Mean Corneal Total Fluorescein Staining Score for the Study Eye and Averaged for Both Eyes at Week 12

  Baseline, Week 12

• 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

  Baseline, Week 12

• 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

  Baseline, Week 12

• Change From Baseline in Mean Tear Osmolarity of Participant Worst Eye Value at Week 12

  Baseline, Week 12

Study Arms (3)

Lotemax Gel 0.5% and Restasis 0.05%

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).

Drug: Lotemax; Drug: Restasis; Drug: Soothe® Lubricant Eye Drops

Lotemax Gel 0.5%

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).

Drug: Lotemax; Drug: Soothe® Lubricant Eye Drops

Restasis 0.05%

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).

Drug: Restasis; Drug: Soothe® Lubricant Eye Drops

Interventions

Lotemax DRUG

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

Also known as: loteprednol etabonate ophthalmic gel 0.5%

Lotemax Gel 0.5%; Lotemax Gel 0.5% and Restasis 0.05%

Restasis DRUG

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

Also known as: cyclosporine ophthalmic emulsion 0.05%

Lotemax Gel 0.5% and Restasis 0.05%; Restasis 0.05%

Soothe® Lubricant Eye Drops DRUG

Also known as: Soothe lubricant eye drops will be administered as needed.

Lotemax Gel 0.5%; Lotemax Gel 0.5% and Restasis 0.05%; Restasis 0.05%

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead
• Synteract, Inc.: collaborator

Study Sites (1)

Bausch & Lomb Incorporated

Irvine, California, 92618, United States

Location

MeSH Terms

Conditions

Keratoconjunctivitis Sicca; Dry Eye Syndromes

Interventions

Loteprednol Etabonate; Cyclosporins; Health Services Needs and Demand

Condition Hierarchy (Ancestors)

Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Eye Diseases; Keratitis; Corneal Diseases; Lacrimal Apparatus Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Peptides, Cyclic; Macrocyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Health Services Research; Health Planning; Health Care Economics and Organizations; Delivery of Health Care; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Director of Clinical Operations
• Organization: Bausch & Lomb Incorporated

Jon.Williams@bauschhealth.com

Study Officials

• Susan Harris

  Bausch Health Americas, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2013
• First Posted: March 25, 2013
• Study Start: May 17, 2013
• Primary Completion: January 10, 2014
• Study Completion: January 10, 2014
• Last Updated: August 30, 2019
• Results First Posted: August 30, 2019

Record last verified: 2019-08

Locations

US (1)