Clinical trials: Ocular Surface Disease
Dry Eye Syndromes, Lubricant Allergy
Safety and Tolerability of PRO-087 Versus Xyel Ofteno® and Systane Ultra®, on the Ocular Surface of Healthy Subjects
Phase I clinical study, to evaluate the safety and tolerability of the preservative-free ophthalmic solution PRO-087 versus Xyel Ofteno® and Systane Ultra®, on the ocular surface of ophthalmological and clinically healthy…
- Conditions
- Dry Eye Syndromes, Lubricant Allergy, Tear Disorder
- Trial name
- PRO-087/I (NCT03524157)
- Testing
- PRO-087, Systane Ultra, Xyel Ofteno
- Where
- Mexico
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Laboratorios Sophia S.A de C.V.
Dry Eye Syndromes
Safety and Tolerability of the Ophthalmic Gel PRO-165 Versus Artelac® Nightime Gel
Objective: To assess the safety and tolerability of the PRO-165 formulation on the ocular surface of ophthalmologically and clinically healthy subjects.
- Trial name
- PRO-165 (NCT03697876)
- Testing
- PRO-165, Artelac
- Where
- Mexico
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Laboratorios Sophia S.A de C.V.
Soft Contact Lenses, Myopia
DAILIES TOTAL1 Versus ACUVUE TruEye - Effects on the Biology of the Ocular Surface and Lid Margin
This is a prospective, single center, randomized, bilateral crossover, dispensing clinical trial to evaluate the effects of the water gradient lens, DAILIES TOTAL1, on the biology of corneal epithelium over two months of daily…
- Trial name
- TruEyeTotal1 (NCT02347631)
- Testing
- Soft Contact Lens - Daily Disposable Alcon Dailies Total 1 and ACUVUE TruEye, Soft Contact Lens - Acuvue TruEye and Alcon DAILIES TOTAL 1.
- Where
- United States
- Volunteers
- 118 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
Myopia
Phase I Clinical Trial to Evaluate the Safety and Tolerability of Ophtalmic Solution PRO-201
Evaluation of the safety and tolerability of PRO-201 (0.01% sulfate atropine) after its instillation on the ocular surface of healthy volunteers through the following variables: unexpected adverse events incidence and photophobia…
- Trial name
- PRO-201 (NCT05470881)
- Testing
- Atropine Sulfate
- Where
- Mexico
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Laboratorios Sophia S.A de C.V.
Dry Eye
Clinical Trial to Evaluate the Safety and Tolerability of Lagricel® Ofteno Multi-dose Ophthalmic Solution
Study design: Phase I clinical trial, single-center, controlled, parallel group, open, randomized. Number of subjects: n = 34 evaluable subjects, 17 evaluable subjects per group (both eyes).
- Trial name
- PRO-037 (NCT04081610)
- Testing
- lagricel ofteno multidose, lagricel ofteno single dose
- Where
- Mexico
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Laboratorios Sophia S.A de C.V.
Ocular Surface Disease
Novel Use of Cyclosporine Ophthalmic Emulsion 0.05% in a PROSE Device
The goal of this prospective observational pilot study is to evaluate the tolerability and safety of RESTASIS (cyclosporine ophthalmic solution 0.05%) when added to the PROSE (Prosthetic Replacement of the Ocular Surface…
- Trial name
- NCT04918823
- Testing
- Restasis
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Boston Sight
Dry Eye, Dry Eye Syndrome of Unspecified Lacrimal Gland
Safety and Tolerability of the Ophthalmic Gel PRO-167 Versus Corneregel® on Healthy Subjects.
Title of the study: Phase I clinical trial, to evaluate the safety and tolerability of the ophthalmic gel PRO-167 versus Corneregel®, on the ocular surface of ophthalmological and clinically healthy subjects.
- Trial name
- PRO-167/I (NCT03520348)
- Testing
- PRO-167, Corneregel
- Where
- Mexico
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Laboratorios Sophia S.A de C.V.
Keratoconjunctivitis Sicca, Dry Eye Syndrome
Effects of Dry Eye Treatments on the Ocular Surface
The purpose of this study is to evaluate whether, in people with dry eye syndrome, over the counter artificial tears and the prescription eye drop, dexamethasone, change or effect the eyes response to a low humidity environment.
- Trial name
- NCT01797822
- Testing
- Dexamethasone, Artificial tear
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Baylor College of Medicine
Keratoconus, Ocular Surface Disease
Pilot Study to Investigate the Feasibility, Reliability and Efficacy of Utilizing OCT to Automate PROSE Fitting
EYEdeal Scanning Technology enables rapid measurement of corneal and scleral topography. By accurately measuring the ocular surface with this imaging technology, the current iterative fitting method required to fit PROSE…
- Conditions
- Keratoconus, Ocular Surface Disease, Pellucid Marginal Corneal Degeneration, Ectasia
- Trial name
- NCT04649177
- Testing
- Ocular surface optical coherence tomography
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Boston Sight
Glaucoma
Safety and Tolerability of the Preservative-free Ophthalmic Solution PRO-122 Compared With Krytantek Ofteno®
Therapeutic indication: Ocular hypotensive Use: Primary open-angle glaucoma and ocular hypertension. Objectives: To evaluate the safety and tolerability of the preservative-free formulation PRO-122 manufactured by Sophia…
- Trial name
- PRO-122/I (NCT03966365)
- Testing
- PRO-122, Krytantek Ofteno®
- Where
- Mexico
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Laboratorios Sophia S.A de C.V.
Conjunctivitis, Conjunctivitis, Bacterial
Safety and Tolerability of the PRO-174 Versus Sophixín Ofteno®, on the Ocular Surface of Healthy Subjects
Phase I clinical trial, to evaluate the safety and tolerability of the ophthalmic solution PRO-174 versus Sophixín Ofteno®, elaborated by Laboratorios Sophia, S.A. of C.V.
- Trial name
- PRO-174/I (NCT03519516)
- Testing
- PRO-174, Sophixín Ofteno®
- Where
- Mexico
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Laboratorios Sophia S.A de C.V.
Diabetic Retinopathy With Macular Edema of Both Eyes (Diagnosis), Central Retinal Vein Occlusion With Macular Edema
Cool vs Room-temperature Artificial Tears
Background and Objective: To evaluate the efficacy of cooled versus room temperature artificial tears in reducing post intravitreal injection (IVI) ocular discomfort.
- Conditions
- Diabetic Retinopathy With Macular Edema of Both Eyes (Diagnosis), Central Retinal Vein Occlusion With Macular Edema, Exudative Age-Related Macular Degeneration, Unspecified Eye, Cystoid Macular Edema
- Trial name
- NCT05832996
- Testing
- Refresh Plus Preservative-free Lubricant Eye Drops
- Where
- United States
- Volunteers
- 124 people, healthy volunteers welcome
- Sponsor
- University of Iowa
Dry Eye Syndrome, Healthy
Non-invasive Ocular Surface Measurements Before and After Interventions
Objectively evaluate the ocular surface (pre-corneal tear film) of individuals prior to and after an intervention (such as a dry eye treatment, environmental change, artificial tear use, or contact lens wear) in a…
- Trial name
- NCT01228929
- Testing
- Environmental Chamber Condition Change Intervention
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- University of Rochester
Dry Eye
Safety and Efficacy of Dexamethasone Ophthalmic Insert (Dextenza®) in the Management of Clinically Significant Dry Eye
To determine efficacy and safety profile of dexamethasone 0.4mg lacrimal insert in dry eye related ocular surface inflammation.
- Trial name
- NCT04498468
- Testing
- Sustained Release Dexamethasone, 0.4 mg, E-Caprolactone-L-Lactide copolymer (PCL) punctal plug
- Where
- United States
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Glaucoma
Safety and Tolerability of the Ophthalmic Solution PRO-179 Compared With Travatan®
Phase I clinical study, to evaluate the safety and tolerability of the ophthalmic solution PRO-179 compared with Travatan®, on the ocular surface of clinically healthy subjects.
- Trial name
- PRO-179/I (NCT03965052)
- Testing
- PRO 179, Travatan 0.004 % Ophthalmic Solution
- Where
- Mexico
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Laboratorios Sophia S.A de C.V.
Dry Eye Syndromes
Impairment of Reading Ability in Dry Eye Patients
To assess the reading function impairment in patients with dry eye and to assess the effects of reading on the ocular surface.
- Trial name
- NCT01826812
- Testing
- 30 minutes sustained reading, Dry eye exam
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Myopia, Refractive Error
Effect of Contact Lens Wear on Immune Cell Density and Morphology of the Ocular Surface
The purpose of this study is to utilize in-vivo confocal microscopy to describe differences in corneal epithelial immune status across three lens care regimens in new contact lens wearers.
- Trial name
- NCT01250925
- Testing
- ReNu MultiPlus® MultiPurpose Solution, OPTI-FREE® RepleniSH®, Clear Care®
- Where
- 2 sites in United States
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Massachusetts Eye and Ear Infirmary
Ophthalmological Agent Toxicity, Bacterial Conjunctivitis
Study to Evaluate the Safety and Tolerability of PRO-231 Versus VIGAMOXI® on the Ocular Surface of Healthy Subjects
This is a phase I clinical study evaluating the safety and tolerability of PRO-231 ophthalmic solution through the incidence of unexpected adverse events, incidence of conjunctival hyperemia and chemosis, changes in Best…
- Trial name
- NCT06363292
- Testing
- PRO-231, VIGAMOXI®
- Where
- Mexico
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Laboratorios Sophia S.A de C.V.