Phase 1 N=29 Phase I Clinical Trial to Evaluate the Safety and Tolerability of Ophtalmic Solution PRO-201
Myopia
Primary: Number of Unexpected Adverse Events — 41 adverse events
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 1 N=100 Safety Study of OPC-12759 Ophthalmic Solution
Dry Eye Syndromes
Primary: Number of Subjects With Blurred Vision After Instillation — 0; 10; 0; 21 participants
Phase 3 N=500 A Six-Week Safety Study of an Investigational Ophthalmic Solution
Allergic Conjunctivitis
Primary: Adverse Events — 0; 0; 0; 0 participants
Phase 2 N=11 OT-551 Antioxidant Eye Drops to Treat Geographic Atrophy in Age-Related Macular Degeneration
Geographic Atrophy · Age-Related Macular Degeneration · AMD
Primary: The Change in Best-corrected Visual Acuity (BCVA) From Baseline to Year 2 for All Participants. — 0.2; -11.3 ETDRS Letters
Phase 1 N=90 Safety and Tolerability of Preservative-free Polyhexamethylene Biguanide (PHMB) Ophthalmic Solution in Healthy Subjects
Acanthamoeba Keratitis
Primary: Number of Subjects With Dose-limiting Adverse Events — 0; 2; 3; 0 participants
Phase 3 N=120 A Study of the Safety and Anesthetic Effect of AG-920 Topical Ophthalmic Solution
Anesthesia, Local
Primary: The Percentage of Patients Who Experienced Ocular Anesthesia Following Treatment of AG-920 Compared to Placebo at 5 Minutes — 50; 11; 10; 49 Participants
Phase 3 N=120 A Study of the Safety and Anesthetic Effect of AG-920 Topical Ophthalmic Solution
Anesthesia, Local
Primary: The Number of Patients Who Experienced Ocular Anesthesia Following Treatment of AG-920 Compared to Placebo at 5 Minutes — 41; 2 Participants
Phase 3 N=516 A Multi-Center, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of AC-170 Ophthalmic Solution
Healthy Subjects
Primary: Tolerability of AC 170 0.24% at Visit 1 (Day 1) — 0.87; 0.50; 0.64; 0.42 units on a scale
Phase 2 N=68 OTX-14-001: A Phase 2 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis
Chronic Allergic Conjunctivitis
Primary: Ocular Itching — 1.80; 2.58; 1.72; 2.70 units on a scale (0 -4)
Phase 3 N=249 A Safety Study of of AG-920 Sterile Topical Ophthalmic Solution
Anesthesia, Local
Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) — 40; 13 Participants
Phase 1 N=30 Pharmacokinetic Study of OPC-1085EL Ophthalmic Solution in Healthy Male Adult Volunteers
Glaucoma · Ocular Hypertension
Primary: Cmax of Carteolol — 0.8558; 0.9984; 1.174; 1.627 ng/mL
Phase 2 N=33 Treatment Safety and Efficacy of Pro-ocular™ 1% for Chronic Ocular Graft Following Allogeneic HSCT.
Chronic Ocular Graft-versus-host Disease
Primary: Modified SANDE Questionnaire - Frequency, Change From Baseline — -22.00; -4.59 score on a scale — p=0.0197
Phase 3 N=73 OTX-14-007: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis
Chronic Allergic Conjunctivitis
Primary: Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 — 1.68; 2.66 units on a scale
Phase 1 N=24 Safety and Tolerability of the Preservative-free Ophthalmic Solution PRO-122 Compared With Krytantek Ofteno®
Glaucoma
Primary: Number of Adverse Events — 28; 31 adverse events — p=0.706
Phase 1 N=30 Safety and Tolerability of the Ophthalmic Solution PRO-156 in Ophthalmologically Healthy Volunteers.
Healthy
Primary: Visual Acuity (VA) — 19.9; 19.83 score on a scale — p=0.890
Phase 3 N=86 OTX-15-002: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis
Chronic Allergic Conjunctivitis
Primary: Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 — 2.04; 2.31 units on a scale
Phase 3 N=60 A Study of Safety and the Local Anesthetic Effect of AG-920 Ophthalmic Solution in a Pediatric Population
Anesthesia, Local
Primary: The Proportion of Participants in Which an Eye Exam Was Able to be Performed — 30; 30 Participants
Phase 2 N=102 Exploratory Study of OPC-12759 Ophthalmic Suspension
Keratoconjunctival Epithelial Disorder
Primary: Change in the Keratoconjunctival Staining Score From Baseline — -3.4; -3.1 scores on a scale — p=0.576
Phase 1 N=30 Safety and Tolerability of the PRO-174 Versus Sophixín Ofteno®, on the Ocular Surface of Healthy Subjects
Conjunctivitis · Conjunctivitis, Bacterial
Primary: Number of Adverse Events (EAS) — 11; 10 adverse events — p=0.749
Phase 1 N=37 Study to Evaluate the Safety and Tolerability of PRO-231 Versus VIGAMOXI® on the Ocular Surface of Healthy Subjects
Ophthalmological Agent Toxicity · Bacterial Conjunctivitis
Primary: Incidence of Unexpected Adverse Events Related to the Interventions — 1; 4 number of related adverse events
Phase 1 N=34 Clinical Trial to Evaluate the Safety and Tolerability of Lagricel® Ofteno Multi-dose Ophthalmic Solution
Dry Eye
Primary: Presence of Adverse Events (AEs) — 7; 8 Participants — p=0.409
Phase 3 N=416 Safety, Efficacy and Pharmacokinetics of OMS302 in Subjects Undergoing Intraocular Lens Replacement With Phacoemulsification
Intraocular Lens Replacement
Primary: Mean Area Under the Curve Analysis of Change-from-Baseline in Pupil Diameter (mm) During Surgery — 0.1; -0.5 mm — p=0.0001
Phase 2 N=87 H-1337 Ophthalmic Solution Phase 1/2
Glaucoma, Open-Angle
Primary: Intraocular Pressure (IOP) — -4.45; -5.16; -4.93; -0.39 mm Hg
Phase 1 N=24 Safety and Tolerability of the Ophthalmic Gel PRO-167 Versus Corneregel® on Healthy Subjects.
Dry Eye · Dry Eye Syndrome of Unspecified Lacrimal Gland
Primary: Goblet Cell Density (GCD) — 444; 440 cells/mm^2 — p=0.285
Phase 1 N=24 Safety and Tolerability of the Ophthalmic Solution PRO-179 Compared With Travatan®
Glaucoma
Primary: Number of Participants With Adverse Events — 10; 11 Participants — p=1.000
Phase 1 N=30 Safety and Tolerability of PRO-087 Versus Xyel Ofteno® and Systane Ultra®, on the Ocular Surface of Healthy Subjects
Dry Eye Syndromes · Lubricant Allergy · Tear Disorder
Primary: Goblet Cell Density (GCD) — 282.5; 326.8; 291.5 cells/mm2 — p=0.273
Phase 1 N=22 Clinical Study for the Evaluation of Safety and Tolerability of PRO-172 Ophthalmic Solution+
Safety · Tolerability · Ocular Surface
Primary: Incidence of Related Unexpected Adverse Events (AE) — 12 Number of unexpected related AE
Phase 2 N=60 Phase II Study Evaluating Safety/Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery
Ocular Inflammation and Pain
Primary: Absence of Cells in Anterior Chamber of Study Eye — 6; 3 Participants
Phase 3 N=438 OTX-15:003: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery
Post-Surgical Ocular Pain · Post-Surgical Ocular Inflammation
Primary: Absence of Anterior Chamber Inflammation — 52.3; 31.1 percentage of total participants
Phase 2 N=39 Safety and Efficacy of Ophthalmic Phentolamine Mesylate in Glaucoma
Open Angle Glaucoma · Ocular Hypertension
Primary: Intraocular Pressure — -2.30; -2.18 mmHg — p=0.89