Phase 4 N=1,405 Cornea Preservation Time Study
Cornea Preservation Time · Endothelial Keratoplasty · Transplant Success
Primary: Number of Eyes With Corneal Graft Failure Within 3 Years of Surgery — 30; 49 Eyes — p=0.02
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Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 3 N=64 Life 4°C Versus Optisol in Corneal Storage Media
Complications of Corneal Transplant
Primary: Endothelial Cell Loss Post EK for Donor Corneas Preserved in Life 4°C and Optisol GS Corneal Storage Media — 20; 18 % endothelial cell loss — p=< 0.05
Phase 2 N=1 Use of Cross-linked Donor Corneas as Carriers for the Boston Keratoprosthesis
Chemical Injuries · Unspecified Complication of Corneal Transplant · Autoimmune Diseases
Primary: Changes in Corneal Thickness at 1 Millimeter — 730; 760; 700; 720 micrometer
N/A N=40 Sutureless Cryopreserved Amniotic Membrane Graft (ProKera) and Wound Healing After Photorefractive Keratectomy
Corneal Wound Healing
Primary: Number of Days to Complete Re-epithelialization — 4.6; 4.1 days to complete re-epithelialization
Phase 2 N=68 Vision Restoration With a Collagen Crosslinked Boston Keratoprosthesis Unit
Keratolysis
Primary: Time From Surgery to Device Loss or Replacement — 95; 34 median weeks from surgery to removal
Phase 4 N=167 Comparison of Corticosteroid Dosing Regimens After Endothelial Keratoplasty
Fuchs' Dystrophy · Corneal Edema
Primary: Intraocular Pressure — 11; 27 eyes
N/A N=1,090 Cornea Donor Study
Corneal Disease · Fuch's Dystrophy · Pseudophakic Corneal Edema
Primary: Graft Failure — 142; 82 participants
N/A N=135 Performance and Safety Assessment of T4020 in Managing Corneal Epithelial Defect Following Epi-off Accelerated Crosslinking
Keratoconus
Primary: Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 3 — 20; 25 Participants
N/A N=60 Corneal Staining and Physiological Compromise After Eight Hours of Soft Contact Lens Wear
Contact Lens-induced Corneal Fluorescein Staining
Primary: The Primary Outcome Measure Will be Corneal Epithelial Dye Diffusion Rate in Nanometers Per Second, for the Test and Control Eyes. — 0.0567; 0.0583 nanometers per second
N/A N=5 Safety and Effectiveness of Collagen-phosphorylcholine Bioengineered Cornea in Patients Requiring Lamellar Keratoplasty
Corneal Ulcer · Leukoma
Primary: Incidence of Treatment-Emergent Adverse Events — 0 events
N/A N=657 Long Term Safety Protocol for the AcrySof CACHET Phakic Lens
Myopia
Primary: Central Endothelial Cell Density (All Eyes) — 2654.0; 2639.0; 2633.0; 2551.0 cells/mm^2
Phase 2 N=10 A Study of the KIO-201 (Ocular Bandage Gel) for Improving Persistent Corneal Epithelial Defects
Persistent Corneal Epithelial Defect
Primary: Percentage of Patients Achieving Corneal Healing (<0.5 mm2 Lesion Size) of the Persistent Corneal Epithelial Defect at 4 Weeks — 5 Participants
N/A N=54 Additional Long-Term Follow-up for Subjects Implanted With a CyPass® Micro-Stent
Primary Open Angle Glaucoma · Cataract
Primary: Percentage of Eyes With Sight-threatening Adverse Events (AEs) — 18.5; 0.0; 0.0; 0.0 percentage of eyes
N/A N=90 Donor After Circulatory Death Heart CAP Trial
Heart Transplant
Primary: Patient Survival — 75 Participants
N/A N=29 Short-Term Evaluation of Corneal Staining With Balafilcon A Lenses and Two Multi-Purpose Solutions
Corneal Staining
Primary: Corneal Staining by Wear Time — 19; 15; 19; 7 participants
Phase 3 N=191 Trial of Netarsudil for Prevention of Corticosteroid-induced Intraocular Pressure Elevation
Fuchs' Endothelial Dystrophy · Bullous Keratopathy
Primary: Intraocular Pressure — 11; 18 Participants
Phase 1 N=165 Topical Autologous Serum Application for the Treatment of Corneal Epithelium Defect After Ocular Surgeries
Corneal Epithelial Defect · Diabetic Retinopathy · Penetrating Keratoplasty
Primary: Patients With Corneal Epithelial Healing Time Within 14 Days — 78; 73 participants
Phase 2 N=30 Comparative Evaluation of Corneal Staining With Balafilcon A Lenses and Two Multi-Purpose Solutions
Myopia · Hyperopia · Astigmatism
Primary: Number of Eyes With No Change in Corneal Staining — 16; 17; 19; 14 eyes
N/A N=16 Tear Film Break-up Time After Instillation of Artificial Tears
Keratoconjunctivitis Sicca
Primary: Noninvasive Tear Film Break-up Time — 14.67; 7.4 seconds
Phase 3 N=239 Study to Evaluate the Safety and Efficacy of Epi-on Corneal Cross-linking in Eyes With Progressive Keratoconus
Progressive Keratoconus
Primary: Difference Between Treatment Groups in the Change From Baseline to Month 6 in Kmax — -0.3; 0.6 Diopters — p=0.0004
Phase 3 N=147 Corneal Collagen Cross-linking for Progressive Keratoconus
Progressive Keratoconus
Primary: Mean Change From Baseline in Maximum Keratometry (Kmax) — -1.7; 0.6 diopters
Phase 3 N=147 Cross-linking for Corneal Ulcers Treatment Trial
Corneal Ulcer · Infectious Keratitis · Bacterial Ulcer
Primary: Microbiological Cure on Repeat Culture — 5; 5; 17; 14 Participants
N/A N=33 Clinical Biocompatibility Evaluation of Contact Lens Coatings
Refractive Errors · Ametropia
Primary: Average Percent Area of Solution-related Corneal Staining — 7.01; 12.82; 13.54; 7.58 percentage of area
Phase 4 N=131 Loteprednol vs. Prednisolone and Fluorometholone
Intraocular Pressure · Corneal Opacity
Primary: Change in Intraocular Pressure (IOP) From Baseline Through Month 3 — 14.38; 14.30; 13.67; 13.28 mmHg
N/A N=40 Study of Eye Bank Pre-cut Donor Grafts for Endothelial Keratoplasty
Fuchs Endothelial Dystrophy · Corneal Edema
Primary: Endothelial Cell Loss — 28; 36 percentage of endothelial cell loss — p=0.10
N/A N=94 Simultaneous TransPRK and Corneal Collagen Cross-Linking
Keratoconus
Primary: Change in LogMAR Corrected Distance Visual Acuity (CDVA) — -0.13; -0.05 LogMAR CDVA — p=0.03
Phase 4 N=70 Loteprednol Etabonate 0.25% for Prevention of Cornea Transplant Rejection
Corneal Endothelial Dystrophy · Corneal Edema
Primary: Immunologic Rejection — 0 Participants
N/A N=151 Safety and Effectiveness of the AcuFocus Corneal Inlay ACI7000PDT in Presbyopes
Presbyopia
Primary: Uncorrected Near Visual Acuity 20/32 or Better — 73.8 percentage of subjects
N/A N=26 Keratometric Tear Breakup Time and Fluorescein Tear Breakup Time
Dry Eye
Primary: Difference Between Keratometric Tear Break Up Time (KTBUT) and Fluorescein Tear Break Up Time (FTBUT) — 5.95; 5.39 time in seconds — p=0.074
Phase 3 N=130 Corneal Collagen Cross-Linking for Ectasia (CXL)
Ectasia
Primary: Mean Change From Baseline in Maximum Keratometry (Kmax) — -0.5; 0.5 diopters