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
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 3 N=310 Safety Study of a Contact Lens With Ketotifen in Healthy, Normal Volunteers
Allergic Conjunctivitis
Primary: Lid and Lid Margin Erythema, Change From Baseline — 0; 0 Units on a scale
Phase 3 N=861 Safety Study for Bepotastine Besilate Ophthalmic Solution in Normal Volunteers
Allergic Conjunctivitis
Primary: Ocular Comfort — 0.13; 0.07; 0.06; 0.02 Scores on a scale
N/A N=15 Non-invasive Tear Film Dynamic Measurements in Normal, MGD and ADDE Subjects After Saline Instillation
Aqueous Deficient Dry Eye · Meibomium Gland Dysfunction
Primary: Visual Quality — 0.3; 0.32; 0.19; 0.3 microns
Phase 3 N=250 Safety Study of a Contact Lens With Ketotifen in Healthy, Normal Volunteers
Allergic Conjunctivitis
Primary: Lid and Lid Margin Erythema, Change From Baseline — 0; 0 Units on a scale
N/A N=20 Wearable Dark-adaptometer in Normal Adult Healthy Volunteers
Photoreceptor Sensitivity Thresholds
Primary: Time to Rod-cone Break (RCB) — 11.34; 9.98 Minutes
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 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=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
N/A N=26 Evaluation of Contact Lenses and Conjunctival Staining in Normal Patients
Conjunctival Staining
Primary: Mean Circumlimbal Conjunctival Staining Score — 6.39; 5.55; 5.68 Units on a scale
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=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
N/A N=39 Meibography and Tear Scan Using the Oculus Keratograph 4
Meibomian Gland Dysfunction
Primary: Meibomium Gland Dropout Score - Evidence of Meibomian Gland Dysfunction (MGD) Confirmed by Meibograhpy Imaging Using the Keratograph 4 Measured on a Subjective Grading…
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 3 N=120 A Study to Evaluate the Efficacy of Investigational OTC Eye Drops
Ophthalmic Solutions
Primary: Clinician Assessment of Change From Baseline in Redness at 60 Seconds After First Product Application — 0.31; 0.27; 0.32 units on a scale — p=0.392
N/A N=24 Open Eye Corneal Swelling With Daily Disposable Contact Lenses and no Lens Wear
Corneal Swelling
Primary: Percentage Change From Baseline of Corneal Swelling 8 Hours Post Fit — 0.07; -0.02; 0.14; -0.06 percentage of change from baseline
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
N/A N=303 Optical Coherence Tomography (OCT) Data Collection Study
Glaucoma
Primary: Primary Endpoints — 97.2; 83.9; 73.9; 336.1 microns
N/A N=51 Normative Database for Pattern Electroretinogram (PERG) and Flash Electroretinogram (FERG)
Glaucoma
Primary: Flash Electroretinogram (FERG) Module Using Diopsys NOVA (Neuro Optic Vision Assessment) Amplitude — -1.68 micro volts
N/A N=230 Study of a Hand-held Device Plus Mobile App Versus Standard Eye Care Devices in Measuring Refractive Error of the Eye
Refractive Errors · Astigmatism
Primary: BVCA Utilizing Refraction Results From Handheld Device Compared to Manual Refraction Methods for the Age Stratum 45 Through 65 Years — 0.06; 0.02; 0.03 logMAR
Phase 3 N=534 Study Evaluating the Safety of KetoNaph Ophthalmic Solution in Healthy Volunteers
Allergic Conjunctivitis
Primary: Percentage of Participants With at Least One Adverse Event. — 113; 34 Participants
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 4 N=50 Corneal and Conjunctival Sensitivity and Staining Study
Myopia · Hyperopia
Primary: Corneal Sensitivity — 26.9; 25.5 percent CO2
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
Phase 4 N=43 Evaluation of Electronic LogMar Visual Acuity and Contrast Sensitivity in a Population of Contact Lens Wearers
Visual Acuity
Primary: Visual Acuity (logMAR) — 0.15; 0.21; 0.02; 0.05 logMAR
Phase 1 N=35 Safety and Tolerability of PRO-155 Ophthalmic Solution 0.09% in Healthy Volunteers.
Inflammation · Cataract
Primary: Visual Acuity — 20.3; 20.2 units on a scale — p=.374
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
N/A N=36 Pilot Study on Ambulatory Intraocular Pressure and Blood Pressure Monitoring in Glaucoma
Normal-Tension Glaucoma
Primary: Arterial Pressure — 100.9; 95.5 mmHg
N/A N=10 Evaluation of Surface Refractive Index Shift of Kalifilcon A Lenses Compared to Dailies Total 1, Precision 1 and Biotrue ONEday Lenses
Habitual Soft Contact Lens Use
Primary: Surface Refractive Index Shifts at 5 Minutes — 1.4102; 1.4251; 1.4188; 1.3788 No units
Phase 1 N=12 Tear Fluid Levels of Loteprednol Etabonate Ophthalmic Gel 0.5% Following a Single Instillation
Pharmacokinetics
Primary: Tear Fluid Levels — 113.633 μg/g