9 completed, 2 terminated. 6 Phase 3, 3 Phase 2, 1 Not applicable, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 6 | Completed 5, Terminated 1 |
| Phase 2 | 3 | Completed 2, Terminated 1 |
| Not applicable | 1 | Completed 1 |
| Phase 4 | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Trial to Evaluate Safety and Efficacy of KPI-012 Ophthalmic Solution in Participants With PCED KPI-012, KPI-012 Vehicle - Persistent Corneal Epithelial Defect | Phase 2 | Terminated | Combangio, Inc | 103 | 2023-02-07 | 2025-10-22 |
| Loteprednol Etabonate 0.25% for Prevention of Cornea Transplant Rejection loteprednol etabonate 0.25% ophthalmic suspension - Corneal Endothelial Dystrophy, Corneal Edema | Phase 4 | Completed | Price Vision Group | 70 | 2021-11-23 | 2024-08-14 |
| Safety and Efficacy of KPI-121 in Subjects With DED KPI-121 Ophthalmic Suspension, Vehicle - Kerato Conjunctivitis Sicca | Phase 3 | Completed | Kala Pharmaceuticals, Inc. | 901 | 2018-07-10 | 2021-04-02 |
| KPI-121 1% Versus Prednisolone for the Treatment of Inflammation Following Cataract Surgery in Children KPI-121 1%, Prednisolone acetate - Ocular Inflammation | Phase 3 | Terminated | Kala Pharmaceuticals, Inc. | 2 | 2018-07-03 | 2020-10-19 |
| Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation and Pain KPI-121 1% Ophthalmic Suspension dosed BID, Vehicle of KPI-121 Ophthalmic Suspension dosed BID - Post Surgical Ocular Inflammation and Pain | Phase 3 | Completed | Kala Pharmaceuticals, Inc. | 520 | 2016-06-01 | 2020-12-16 |
| Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease KPI-121 0.25% Ophthalmic Suspension, Vehicle of KPI-121 0.25% Ophthalmic Suspension - Dry Eye Syndromes, Keratoconjunctivitis Sicca | Phase 3 | Completed | Kala Pharmaceuticals, Inc. | 918 | 2016-06-01 | 2021-02-03 |
| Safety and Efficacy of KPI-121 Compared to Placebo in Subjects With Dry Eye Disease KPI-121 0.25% Ophthalmic Suspension, Vehicle of KPI-121 0.25% Ophthalmic Suspension - Dry Eye Syndromes, Keratoconjunctivitis Sicca | Phase 3 | Completed | Kala Pharmaceuticals, Inc. | 909 | 2016-06-01 | 2021-01-05 |
| Exploratory Study of KPI-121 Effect on Intra- or Subretinal Fluid Due to Retinal Vein Occlusion/Diabetic Macular Edema KPI-121 0.25% Ophthalmic Suspension, KPI-121 1.0% Ophthalmic Suspension - Retinal Vein Occlusion, Diabetic Macular Edema | Not applicable | Completed | Kala Pharmaceuticals, Inc. | 16 | 2014-07-01 | 2020-12-10 |
| Safety and Efficacy of KPI-121 in Subjects With Inflammatory Meibomian Gland Disease KPI-121, Vehicle - Blepharitis | Phase 2 | Completed | Kala Pharmaceuticals, Inc. | 206 | 2014-07-01 | 2021-01-11 |
| Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease KPI-121, Placebo - Dry Eye Syndromes, Keratoconjunctivitis Sicca | Phase 2 | Completed | Kala Pharmaceuticals, Inc. | 150 | 2014-06-01 | 2021-01-06 |
| Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation KPI-121 0.25%, KPI-121 1.0%, Vehicle of KPI-121 0.25% - Ocular Infections, Irritations and Inflammations | Phase 3 | Completed | Kala Pharmaceuticals, Inc. | 380 | 2014-05-01 | 2021-01-29 |
Pain (6) · Dry Eye Syndromes (4) · Hyperemia (3) · Keratoconjunctivitis Sicca (3) · Cataract (2) · Inflammation (2) · Blepharitis (1) · Corneal Dystrophy, Posterior Polymorphous, 1 (1) · Corneal Edema (1) · Eye Infections (1) · Meibomian Gland Dysfunction (1) · Retinal Vein Occlusion (1)
Loteprednol Etabonate (6) · prednisolone acetate (1)
United States (11) · Argentina (1) · Puerto Rico (1)
Jodi Luchs, MD (2) · Kenneth Sall, MD (2) · Marc Abrams, MD (2) · Steven Rauchman, MD (2) · Damien Goldberg, MD (1) · David Evans, OD (1) · Francis W Price, Jr., MD (1) · Gregg Berdy, MD (1) · Jeffrey Whitsett, MD (1) · John Sheppard, MD (1) · Joseph Martel, MD (1) · Joseph Tauber, MD (1) · Kathy Kelley, OD (1) · Kelly Nichols, OD, PhD (1) · Kristie Veasey (1)