Clinical trials: Ocular Surface
Safety, Tolerability
Clinical Study for the Evaluation of Safety and Tolerability of PRO-172 Ophthalmic Solution+
Clinical phase I, controlled, non comparative, open, single center study evaluating the safety and tolerability of ophthalmic solution PRO-172 when applied on the ocular surface of healthy volunteers.
- Conditions
- Safety, Tolerability, Ocular Surface, Ocular Comfort
- Trial name
- PRO-172 (NCT04693429)
- Testing
- Bepotastine Besilate
- Where
- Mexico
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Laboratorios Sophia S.A de C.V.
Hyperemia Eye
Safety and Tolerability of PRO-185
Phase I Study to evaluate safety and tolerability of PRO-185 (naphazoline/hypromellose) ophthalmic solution through evaluation of vital signs, ocular signs such as intraocular pressure, hyperemia and mydriasis and adverse events.
- Trial name
- PRO-185 (NCT05470868)
- Testing
- Naphazoline / Hypromellose Ophthalmic
- Where
- Mexico
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Laboratorios Sophia S.A de C.V.
Ocular Discomfort
Safety and Efficacy of 2 Concentrations of Lubricin vs Sodium Hyaluronate in Ocular Discomfort After Refractive Surgery.
The objective of this study was to evaluate tolerability, safety, permanence on the ocular surface and efficacy of Lubricin (20 and 50 μg/mL) eye drops vs Sodium Hyaluronate (Vismed®) 0.18% eye drops in patients with ocular…
- Trial name
- NCT03031327
- Testing
- Lubricin 20µg/ml, Lubricin 50µg/ml, Sodium hyaluronate 0.18%
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- Dompé Farmaceutici S.p.A
Glaucoma, Ocular Hypertension
Effects of Travatan Z and Xalatan on Ocular Surface Health
The purpose of this randomized, double-masked, parallel-group, multicenter study is to evaluate ocular surface effects after the administration of travoprost with SofZia® preservative system or Xalatan once daily for 12 weeks.
- Trial name
- NCT00708422
- Testing
- Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®), Latanoprost ophthalmic solution 0.005% (XALATAN®)
- Volunteers
- 231 people
- Sponsor
- Alcon Research
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.
Dry Eye
Phase 3 Study of the Safety and Efficacy of OmegaD Softgels in the Treatment of Dry Eye Disease
This is a phase 3 study to evaluate the safety and efficacy of OmegaD softgels for the treatment of dry eye disease. A daily dose of 2 OmegaD softgels dosed orally BID will be compared to 2 placebo softgels (mineral oil ) dosed…
- Trial name
- NCT04181593
- Testing
- Omega 3 fatty acid
- Where
- 14 sites in United States
- Volunteers
- 322 people
- Sponsor
- OmegaD LLC
Glaucoma, Open-Angle, Ocular Hypertension
Ocular Surface Tolerability Study of Prostaglandin Analogues in Patients With Open-Angle Glaucoma or Ocular Hypertension
This study evaluated the ocular surface tolerability of the prostaglandin analogues bimatoprost ophthalmic solution 0.01% (Lumigan® 0.01%), travoprost ophthalmic solution 0.004% (Travatan Z®) and latanoprost ophthalmic solution…
- Trial name
- NCT01253902
- Testing
- bimatoprost ophthalmic solution 0.01%, travoprost ophthalmic solution 0.004%, latanoprost ophthalmic solution 0.005%
- Where
- 2 sites in United States, Canada
- Volunteers
- 164 people
- Sponsor
- Allergan
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.
Dry Eye Syndromes, Keratoconjunctivitis Sicca
Safety and Efficacy of Carboxymethylcellulose for Ocular Surface Integrity in Symptomatic Dry Eye
This study will evaluate the safety and efficacy of OPTIVE® MD for ocular surface integrity in symptomatic dry eye condition in absence of obvious eye-lid inflammation.
- Trial name
- NCT00987727
- Testing
- carboxymethylcellulose 0.5% , glycerin 0.9% (OPTIVE® MD), sodium hyaluronate 0.18% (VISMED® Multi)
- Where
- France
- Volunteers
- 82 people
- Sponsor
- Allergan
Open-angle Glaucoma, Ocular Hypertension
Travatan Z in Ocular Surface Health in Patients With Open-Angle Glaucoma or Ocular Hypertension
The purpose of the study is to compare two ophthalmic solutions in patients with open-angle glaucoma or ocular hypertension.
- Trial name
- NCT00690794
- Testing
- Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®), Latanoprost ophthalmic solution 0.005% (XALATAN®)
- Volunteers
- 726 people
- Sponsor
- Alcon Research
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.
Visual Acuity
An Investigation of the Impact of Localized Topical Anesthesia of the Ocular Surface on End-of-day Contact Lens Discomfort
This is a controlled, randomized, subject-masked, 3x3 crossover, non-dispensing, contralateral study. Twenty subjects will be recruited based on their scores (with their habitual lenses) from the Contact Lens Dry Eye…
- Trial name
- NCT03733899
- Testing
- Local Anesthesia
- Where
- United Kingdom
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Vision Care, Inc.
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.
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.
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.
Local Anesthetic
Efficacy and Safety of Chloroprocaine 3% Gel and Oxybuprocaine 0.4% Eye Drops Anesthesia in Pediatric Population
The goal of this clinical trial is to assess the efficacy and safety of Chloroprocaine 3% eye gel compared to Oxybuprocaine 0,4% eye drops when used for inducing ocular surface anesthesia in pediatric patients.
- Trial name
- NCT05926258
- Testing
- Chloroprocaine 3% eye gel, Oxybuprocaine Hydrochloride 4 Mg/mL Eye Drops
- Where
- 3 sites in Italy
- Volunteers
- 74 people
- Sponsor
- Sintetica SA
Chronic Ocular Pain
Study of Efficacy and Safety of SAF312 Eye Drops in Subjects With Post-operative Corneal Induced Chronic Pain (CICP)
The study was designed to demonstrate the safety and efficacy of two dose concentrations of SAF312 eye drops (5 mg/mL and 15 mg/mL) in subjects with CICP persisting at least for 4 months after refractive or cataract surgery and…
- Trial name
- NCT04630158
- Testing
- SAF312
- Where
- 28 sites in United States, Japan and 1 more
- Volunteers
- 153 people
- Sponsor
- Novartis Pharmaceuticals
Dry Eye Disease
A Study to Investigate the Effect of 0.003% AR-15512 on Subjects With Dry Eye Disease
The purpose of this study is to evaluate the effect of AR-15512 ophthalmic solution 0.003% (0.003% AR-15512) on ocular surface characteristics of subjects with dry eye disease (DED).
- Trial name
- NCT06544694
- Testing
- 0.003% AR-15512 ophthalmic solution, Artificial Tears
- Where
- 4 sites in United States
- Volunteers
- 80 people
- Sponsor
- Alcon Research
Dry Eye
Efficacy and Safety Study of FID 119515A
The purpose of this study was to compare the effect of FID 119515A to Blink® Tears on the integrity of tear film in adults with a history of dry eye in both eyes.
- Trial name
- NCT01833117
- Testing
- FID 119515A, Blink® Tears
- Volunteers
- 75 people
- Sponsor
- Alcon Research