Phase 2
N=102
Lotemax® Gel 0.5% and Restasis 0.05% in Participants With Mild or Moderate Keratoconjunctivitis Sicca (Dry Eye Disease)
Keratoconjunctivitis Sicca
Bottom Line
View on ClinicalTrials.gov: NCT01817582 ↗Enrolled (actual)
102
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Change From Baseline in Corneal Total Fluorescein Staining Score at for the Study Eye at Week 4 — -1.3; -1.7; -1.3 units on a scale — p=0.6199
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Lotemax (Drug); Restasis (Drug); Soothe® Lubricant Eye Drops (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Bausch & Lomb Incorporated
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Corneal Total Fluorescein Staining Score at for the Study Eye at Week 4 |
-1.3; -1.7; -1.3 | 0.6199 |
| PRIMARY Change From Baseline in Mean Ocular Surface Disease Index (OSDI) Questionnaire Total Score at Week 4 |
-5.2; -1.3; -0.6 | 0.2296 |
| PRIMARY Percentage of Participants With Adverse Events (AEs) |
27.3; 25.0; 27.3 | — |
| PRIMARY Mean Grade for Participant-Reported Post-Dosing Ocular Comfort Values |
0.5; 0.6; 0.5 | — |
| SECONDARY Change From Baseline in Mean OSDI Questionnaire Total Score and Individual Question Scores at Week 12 |
1.5; 1.5; 1.4; -0.2; -0.1; -0.2 | — |
| SECONDARY Change From Baseline in Mean Corneal Total Fluorescein Staining Score for the Study Eye and Averaged for Both Eyes at Week 12 |
5.6; 5.7; 5.5; -1.3; -0.7; -1.6 | — |
| SECONDARY 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 |
1.2; 1.2; 1.0; -0.5; -0.6; -0.3 | — |
| SECONDARY 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 |
8.5; 9.2; 7.7; -0.9; -1.8; -1.2 | — |
| SECONDARY Change From Baseline in Mean Tear Osmolarity of Participant Worst Eye Value at Week 12 |
312.1; 307.4; 311.6; 0.7; 4.3; -1.5 | — |
| SECONDARY Change From Baseline in Mean Tear Osmolarity Between Two Eyes of Participant at Week 12 |
7.9; 5.4; 7.2; 0.6; 2.9; -0.3 | — |
| SECONDARY Change From Baseline in Mean Eye Comfort Index Questionnaire Total Score and Individual Question Scores at Week 12 |
2.3; 2.2; 2.2; -0.4; -0.1; -0.4 | — |
| SECONDARY Change From Baseline in Mean Eye Dryness Questionnaire Total and Individual Question Scores at Week 12 |
2.2; 2.1; 2.1; -0.4; -0.2; -0.3 | — |
| SECONDARY 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 |
2.87; 3.23; 3.09; 0.25; 0.32; 0.16 | — |
| SECONDARY 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 |
6.49; 8.11; 7.18; 0.59; 1.09; 0.31 | — |
| SECONDARY 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 |
6.1; 6.6; 6.6; 2.5; 1.7; 2.5 | — |
| SECONDARY Averaged Daily Soothe Lubricant Eye Drops Usage |
2.07; 1.79; 2.04 | — |
| SECONDARY Number of Participants With Overall Change From Baseline in Dry Symptoms at Week 12 as Assessed Independently by Investigators and Participants |
0; 2; 3; 7; 11; 10 | — |
| SECONDARY Change From Baseline in Ocular Redness Score for Study Eye and Averaged for Both Eyes at Week 12, as Assessed by Investigator |
1.0; 1.0; 1.0; -0.1; -0.2; -0.1 | — |
| SECONDARY 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 |
0.608; 0.615; 0.625; 0.039; 0.015; 0.004 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01817582). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.