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
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Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=150 A Study to Assess the Local Cutaneous and Ocular Tolerance of Three Developmental Facial Skin-care Formulations.
Skin Care
Primary: Number of Participants Determined by a Dermatologist to Have a Clinically Relevant Positive Outcome for Cutaneous Irritation After 21 Days of Product Use — 1; 0; 0…
N/A N=30 Tolerance to Residual Astigmatism in Eyes With Vivity®
Lenses, Intraocular
Primary: Distance Against the Rule Astimatism — 0.01 LogMAR
N/A N=211 Tolerability of Bimatoprost 0.01% vs Latanoprost Eye Drops
Glaucoma
Primary: Tolerability of Medications as Measured by the COMTOL Validated Instrument — 23; 50; 26; 29 percentage of patients
N/A N=72 Ocular Comfort and the "Aging" Lens (ERBIUM)
Refractive Error
Primary: Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 1 — 76; 88 Units on a scale
Phase 4 N=164 Ocular Surface Tolerability Study of Prostaglandin Analogues in Patients With Open-Angle Glaucoma or Ocular Hypertension
Glaucoma, Open-Angle · Ocular Hypertension
Primary: Mean Conjunctival Hyperemia at Week 12 — 0.42; 0.46; 0.44 Score on a scale
N/A N=108 Acceptance & Tolerance Study of Multifocal Contact Lenses by Functional Emmetropes
Vision Correction
Primary: Proportion of Successful Contact Lens Wearers — 0.71 Proportion of Subjects
N/A N=47 Safety and Tolerability of Artificial Tears in Dry Eye Subjects
Dry Eye Syndrome
Primary: Tolerability Questionnaire Mean Scores at 1 Week — 70.1; 70.7; 57.3; 65.1 Scores on a scale
N/A N=35 A Clinical Study of Systane® Lid Wipes in Brazil
Ocular Tolerance · Skin Tolerance
Primary: Number of Participants With a Contact-dermatitis Adverse Reaction — 0 participants
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=20 Ocular Comfort and OCT Observation of Post Lens Clearance and Ocular Tissue Compression
Ocular Comfort
Primary: Final Comfort — 87.6; 87.9 Units on a scale
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 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=19 CLN-0045: Safety, and Efficacy of OTX-TIC in Participants With Open Angle Glaucoma or Ocular Hypertension
Ocular Hypertension · Open Angle Glaucoma
Primary: Ocular Treatment Emergent Adverse Events — 9; 7; 9; 1 Number of Treatment-Emergent Events
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 3 N=500 A Six-Week Safety Study of an Investigational Ophthalmic Solution
Allergic Conjunctivitis
Primary: Adverse Events — 0; 0; 0; 0 participants
Phase 1 N=32 Safety and Tolerability of the Ophthalmic Gel PRO-165 Versus Artelac® Nightime Gel
Dry Eye Syndromes
Primary: Adverse Events — 3; 5 Participants
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=40 Safety and Efficacy of Topical Tacrolimus 0.05% in the Treatment of Ocular Graft-Versus-Host Disease
Ocular GVHD
Primary: Ocular Burning Sensation, Ocular Discharge, Ocular Redness, Ocular Itching, Foreign Body Sensation — 3.50; 2.23; 0.16; 0.26 units on a scale — p=0.0019
Phase 2 N=100 Ocular Tolerability of Voclosporin Ophthalmic Solution Versus Restasis® in Subjects With Dry Eye Disease
Dry Eye
Primary: Change From Baseline in Drop Discomfort Post Dose Instillation on Day 1 — 7.9; 3.5 mm — p=0.1491
N/A N=41 SENSIMED Triggerfish Safety and Tolerability
Glaucoma
Primary: Ocular Discomfort — 25.5 mm
Phase 1 N=22 Safety and Tolerability of PRO-185
Hyperemia Eye
Primary: Intraocular Pressure (IOP) Increment — 14.00; 13.57; 13.47; 13.25 mmhg
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
N/A N=251 Performance and Safety of T2769 in DED
Dry Eye
Primary: Surface Ocular Staining With Fluorescein (With Oxford Scale - Ranges : Minimum 0- Maximum 15) — -2.3; -2.1 score on a scale
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 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=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
N/A N=30 Safety and Efficacy of 2 Concentrations of Lubricin vs Sodium Hyaluronate in Ocular Discomfort After Refractive Surgery.
Ocular Discomfort
Primary: Changes From Baseline (Day 1 Pre-dose) in Ocular Tolerability Using a Visual Analogue Scale (VAS) — -22.8; -30.1; -20.9; -20.9 mm — p=0.3474
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