22 completed. 22 Phase 3, 3 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 22 | Completed 22 |
| Phase 2 | 3 | Completed 3 |
Follow Keratoconjunctivitis Sicca: new trials by email Literature Review of Keratoconjunctivitis Sicca trials Research Report on Keratoconjunctivitis Sicca
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 |
|---|---|---|---|---|---|---|
| Vizol S DIGI EYE Efficacy and Safety Study in Patients With Dry Eye Vizol S DIGI EYE eye drops, 0,9% saline solution, eye drops - Dry Eye Disease (DED) | Phase 3 | Completed | Jadran Galenski laboratorij d.d. | 86 | 2024-03-20 | 2025-07-03 |
| Vizol S Lipid Balance Efficacy and Safety Study in Patients With Dry Eye Vizol S LIPID BALANCE eye drops, ophthalmic saline eye drops - Dry Eye Disease | Phase 3 | Completed | Jadran Galenski laboratorij d.d. | 64 | 2022-06-01 | 2024-03-21 |
| Safety Study of Tivanisiran to Treat Dry Eye Tivanisiran sodium ophthalmic solution, Vehicle ophthalmic solution - Dry Eye Disease | Phase 3 | Completed | Sylentis, S.A. | 301 | 2022-03-24 | 2026-09-09 |
| Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome Tivanisiran sodium ophthalmic solution, Vehicle ophthalmic solution - Dry Eye Disease, Sjögren Syndrome | Phase 3 | Completed | Sylentis, S.A. | 203 | 2021-05-25 | 2024-02-20 |
| Dose Ranging Study to Assess the Efficacy and Safety of Voclosporin Ophthalmic Solution in Subjects With Dry Eye Syndrome 0.05% Voclosporin Ophthalmic Solution (VOS), 0.10% VOS, 0.20% VOS - Dry Eye Syndrome, Keratoconjunctivitis Sicca | Phase 2 / Phase 3 | Completed | Aurinia Pharmaceuticals Inc. | 508 | 2019-10-14 | 2021-12-10 |
| Tavilermide Ophthalmic Solution for the Treatment of Dry Eye Tavilermide ophthalmic solution, Placebo - Keratoconjunctivitis Sicca, Dry Eye | Phase 3 | Completed | Mimetogen Pharmaceuticals USA, Inc. | 623 | 2019-03-28 | 2023-04-05 |
| An Open-Label Extension of a Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca OTX-101 0.09% - Keratoconjunctivitis Sicca | Phase 3 | Completed | Sun Pharmaceutical Industries Limited | 258 | 2016-07-29 | 2021-11-19 |
| 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 |
| Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca cyclosporine, vehicle of OTX-101 - Keratoconjunctivitis Sicca | Phase 3 | Completed | Sun Pharmaceutical Industries Limited | 745 | 2016-02-01 | 2022-08-29 |
| A Safety and Efficacy Study of Tavilermide (MIM-D3) Ophthalmic Solution for the Treatment of Dry Eye Disease 1% Tavilermide Ophthalmic Solution, Placebo Ophthalmic Solution - Keratoconjunctivitis Sicca | Phase 3 | Completed | Mimetogen Pharmaceuticals USA, Inc. | 400 | 2016-01-01 | 2019-08-16 |
| A Safety and Efficacy Study of Tavilermide (MIM-D3) Ophthalmic Solution for the Treatment of Dry Eye 1% Tavilermide Ophthalmic Solution, Placebo Ophthalmic Solution - Keratoconjunctivitis Sicca | Phase 3 | Completed | Mimetogen Pharmaceuticals USA, Inc. | 429 | 2015-12-01 | 2019-08-16 |
| Phase 2/3 Dose-Ranging Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca OTX-101 0.05%, OTX-101 0.09%, Vehicle - Keratoconjunctivitis Sicca, Dry Eye Disease | Phase 2 / Phase 3 | Completed | Sun Pharmaceutical Industries Limited | 455 | 2014-09-01 | 2022-08-29 |
| Efficacy and Safety of Fluorometholone (FML) in Dry Eye Disease (Keratoconjunctivitis Sicca) FML 0.1% eyedrops, Liquifilm artificial tears eyedrops - Dry Eye | Phase 3 | Completed | Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA | 41 | 2014-02-01 | 2015-01-08 |
| Safety and Efficacy Study of SAR 1118 to Treat Dry Eye Conducted in a Controlled Adverse Environment (CAE) (OPUS-1) Lifitegrast, Placebo - Keratoconjunctivitis Sicca, Dry Eye Disease | Phase 3 | Completed | Shire | 588 | 2011-08-29 | 2021-06-11 |
| Trial of CF101 to Treat Patients With Dry Eye Disease CF101 - Keratoconjunctivitis Sicca | Phase 3 | Completed | Can-Fite BioPharma | 236 | 2011-07-01 | 2022-06-30 |
| Safety and Efficacy Study of EGP-437 (Dexamethasone Phosphate Formulated for Ocular Iontophoresis) to Treat Dry Eye Dexamethasone phosphate ophthalmic solution, Sodium citrate buffer solution - Dry Eye | Phase 3 | Completed | Eyegate Pharmaceuticals, Inc. | 198 | 2010-06-01 | 2011-04-27 |
| Dry Eye Assessment and Management: Feasibility Study Omega-3 EFA Supplement, Olive Oil - Dry Eye Syndromes, Keratoconjunctivitis Sicca | Phase 2 / Phase 3 | Completed | Asbell, Penny, M.D. | 23 | 2010-01-01 | 2012-08-23 |
| Study of Rebamipide Eye Drops to Treat Dry Eye Rebamipide 1%, Rebamipide 2%, Placebo - Keratoconjunctivitis Sicca | Phase 3 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 762 | 2004-05-01 | 2026-06-24 |
| A 1-Year Study in Multiple Clinics Testing Rebamipide Eye Drops for Dry Eye Compared With a Placebo Rebamipide 1%, Rebamipide 2%, Placebo - Keratoconjunctivitis Sicca | Phase 3 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 755 | 2004-05-01 | 2026-06-15 |
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Dry Eye Syndromes (21) · Hyperemia (2) · Pain (2) · Sjogren's Syndrome (2) · Arthritis, Rheumatoid (1) · Asthenopia (1) · Autoimmune Diseases (1) · Fatigue (1) · Lupus Erythematosus, Systemic (1) · Myositis (1) · Scleroderma, Diffuse (1) · Scleroderma, Systemic (1)
Conjunctival Diseases (22) · Conjunctivitis (22) · Corneal Diseases (22) · Eye Diseases (22) · Keratitis (22) · Keratoconjunctivitis (22) · Lacrimal Apparatus Diseases (22) · Pathological Conditions, Signs and Symptoms (3) · Signs and Symptoms (3) · Arthritis (2) · Cardiovascular Diseases (2) · Connective Tissue Diseases (2) · Immune System Diseases (2) · Joint Diseases (2) · Mouth Diseases (2)
Loteprednol Etabonate (2) · Ophthalmic Solutions (2) · rebamipide (2) · CF101 (1) · Cyclosporine (1) · Fluorometholone (1) · Lubricant Eye Drops (1) · N(6)-(3-iodobenzyl)-5'-N-methylcarboxamidoadenosine (1) · Olive Oil (1) · lifitegrast (1)
Mimetogen Pharmaceuticals USA, Inc. (3) · Sun Pharmaceutical Industries Limited (3) · Jadran Galenski laboratorij d.d. (2) · Kala Pharmaceuticals, Inc. (2) · Otsuka Pharmaceutical Development & Commercialization, Inc. (2) · Sylentis, S.A. (2) · Allergan (1) · Asbell, Penny, M.D. (1) · Aurinia Pharmaceuticals Inc. (1) · Can-Fite BioPharma (1) · Eyegate Pharmaceuticals, Inc. (1) · Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA (1) · Merck Sharp & Dohme LLC (1) · Shire (1)
United States (16) · Serbia (2) · Spain (2) · Israel (1)
Garth Cumberlidge, PhD (2) · Gail L Torkildsen, MD (1) · Gary Foulks, MD (1) · Karen Meerovitch, PhD (1) · Margarita Calonge-Cano, MD, PhD (1) · Mary Palmen (1) · Michael H Silverman, MD (1) · Penny Asbell, • MD (1)
PMID 24289915, PMID 25473263, PMID 27445067, PMID 28736342, PMID 28736344, PMID 33469259, PMID 36729473, PMID 42837491
R34EY017626 (1)