Active/Enrolling Studies

Condition

Description

Dates

Sponsor

CRO

Dry Eye Disease

A phase 3, double-masked, randomized, controlled study of ophthalmic suspension compared to vehicle in subjects with dry eye disease.

September 2018 - Present

Kala Pharmaceuticals

Lexitas Pharma

Glaucoma/ Ocular Hypertension

A comparison of investigational product to selective laser trabeculoplasty in patients with open-angle glaucoma or ocular hypertension.

March 2018- Present

Allergan, Inc.

N/A

Neurotrophic Keratopathy

A phase 3, multi-center, randomized, double-masked, placebo-controlled clinical Study to Assess the safety and efficiency of an investigational ophthalmic solution for the treatment of neurotrophic keratopathy.

May 2017- Present

ReGenTree, LLC

Ora, Inc.

Adenoviral Conjunctivitis

A phase 3, multi-center, randomized, double-masked study to evaluate the clinical efficacy and safety of investigational ophthalmic suspension compared to placebo in the treatment of adenoviral conjunctivitis.

May 2017- Present

Shire

IQVIA (Quintiles)

Presbyopia

A phase 3, multicenter, double-masked, randomized, vehicle-controlled, parallel-group study evaluating the safety and efficacy of investigational ophthalmic solution in participants with presbyopia

January 2019- Present

Allergan

N/A

 

Completed Studies

Condition

Description

Dates

Sponsor

CRO

Non-infections Anterior Uveitis

 

A phase 3 randomized, double-masked, vehicle-controlled trial to evaluate the safety and efficacy of an ophthalmic solution in subjects with non-infectious anterior uveitits.

August 2018-February 2019

Aldeyra

Lexitas Pharma

Dry Eye Disease

A double-masked, randomized, multi-center, placebo-controlled, parallel group study to assess the safety and efficacy 0.001% study drug for the treatment of patients with dry eye disease.

August 2018 – February 2019

Senju Pharmaceuticals

PPD

Cataract Surgery

A phase 1/2 dose-ranging, open-label, randomized, clinical study to assess the efficacy and safety of a topical ophthalmic suspension for the treatment of inflammation associated with cataract surgery.

August 2018 – February 2019

iDrop, Inc.

PPD

Glaucoma/ Ocular Hypertension

A randomized, double-masked, active-controlled, parallel group, multi-center bioequivalence study of a generic 1% ophthalmic suspension compared to reference listed drug ophthalmic suspension 1% in subjects with primary open angle glaucoma or ocular hypertension.

April 2018- November 2018

Valeant Pharmaceuticals

Lexitas Pharma

Cataract Surgery

A randomized, multicenter, double masked, placebo controlled, parallel group, bioequivalence study to evaluate the clinical equivalence and safety of a generic 0.3% ophthalmic suspension compared to the name brand ophthalmic suspension 0.3% for the treatment of pain and inflammation associated with cataract surgery.

March 2018- December 2018

Actavis, LLC

TOTAL Clinical

Trial Management

Sjögren’s

Syndrome

A double-masked, randomized, multi-center phase 2 study to evaluate the efficacy and safety of investigational ophthalmic solution in subjects with dry eye associated with primary Sjögren’s syndrome.

July 2017- Present

Tear Solutions, Inc.

Lexitas Pharma

Bacterial Conjunctivitis

A phase 3, multi-center, randomized, double-masked study to evaluate the clinical efficacy and safety of investigational ophthalmic suspension compared to placebo in the treatment of bacterial conjunctivitis.

May 2017- November 2018

Shire

IQVIA

Dry Eye Disease

 

Multicenter, randomized, controlled, double-masked clinical trial to evaluate the efficacy of a nasal spray on signs and symptoms of dry eye disease.

August 2018 - September 2018

Oyster Point Pharmaceuticals

Ora, Inc.

Chalazion

A multi-center, double-masked, randomized, placebo-controlled evaluation of the safety and efficacy of an investigational product transdermal system (TDS) as compared to placebo TDS in patients with a chalazion.

July 2017- July 2018

Senju USA, Inc.

Syneos Health/INC Research

Presbyopia

A prospective, multi-center clinical trial of an investigational implant system for improvement of near visual acuity in presbyopic patients.

November 2014- 2017

Refocus Group

Quality Data Services

Dry Eye Disease

A multi-center, randomized, controlled, double-masked clinical trial to evaluate the efficacy of investigational nasal spray on signs and symptoms of dry eye disease.

March 2018 - April 2018

Oyster Point Pharmaceuticals

Ora, Inc.

Dry Eye Disease

A Phase 2b/3, multi-center, randomized, double-masked, vehicle-controlled clinical study to assess the efficacy and safety of topical ocular solution for the treatment of signs and symptoms of dry eye disease.

November 2017- February 2018

Novaliq GmbH

Ora, Inc.

Dry Eye Disease

A multi-center, randomized, double-masked, placebo controlled clinical study to assess the safety and efficacy of investigational ophthalmic solution for the treatment of dry eye in a controlled adverse environment.

January 2017- March 2017

ReGenTree

Ora, Inc.

Presbyopia

A phase 2, multicenter, double-masked, randomized, vehicle-controlled, parallel-group study evaluating the safety, efficacy and pharmacokinetics of a fixed combination of investigational products (ophthalmic solution) in patients with presbyopia.

June 2016- August 2017

Allergain, Inc.

N/A

Dry Eye Disease

A phase 3, double-masked, randomized, controlled study of investigational ophthalmic suspension compared to vehicle in subjects with dry eye disease.

July 2016- September 2017

Kala Pharmaceuticals

Lexitas Pharma

Corneal Wound

A double-masked, randomized, multicenter, placebo-controlled parallel-group study of investigational ophthalmic solution compared with placebo to assess safety and efficacy of two dose concentrations for corneal epithelial wound healing in subjects with moderated to severe corneal epithelial disorders.

October 2016-  April 2017

Senju Pharmaceutical Co., Ltd.

PPD, Inc.

Glaucoma

A phase 1-2 multi-center, randomized, controlled, dosing-finding study designed to evaluate the safety and ocular hypotensive efficacy of 3 dose levels of the investigational sustained release subconjunctival insert in subjects with open-angle glaucoma or ocular hypertension.

September 2016- April 2017

ViSci, Ltd.

PRN Pharmaceutical Research Network

Dry Eye Disease

Multi-center, randomized, controlled, single-masked, cross-over clinical trial to evaluate the reduction in the exacerbation of dry eye symptoms upon exposure to a controlled adverse environment with treatment by an investigational device.

September 2016- November 2016

Allergan/Oculeve

Ora, Inc.

Cataract Surgery

A phase 3, double-masked, randomized, controlled study to evaluate the safety and efficacy of investigational ophthalmic suspension in subjects with postsurgical inflammation and pain.

June 2016- April 2017

Kala Pharmaceuticals

Lexitas Pharma

Dry Eye Disease

A safety and efficacy study of investigational ophthalmic solutions for the treatment of dry eye disease.

January 2016- September 2016  

Mimetogen Pharmaceuticals

Ora, Inc.

Glaucoma/ Ocular Hypertension

A phase 3 prospective, double-masked, randomized, multi-center, active-controlled, parallel group, 12-month study assessing the safety and ocular hypotensive efficacy of investigative ophthalmic solution compared other ophthalmic solution, 0.02%, and another ophthalmic solution, 0.005% in subjects with elevated intraocular pressure.

September 2015- July 2017

Aerie Pharmaceuticals

Rho, Inc.

Dry Eye Disease

 

A phase 3 multi-center, double-masked, randomized, controlled, efficacy and safety study of investigational topical ophthalmic solution versus vehicle control in subjects with moderate to severe dry eye disease.

March 2014- November 2015

Eleven Biotherapeutics, Inc.

PPD, Inc.

Glaucoma and Cataract

Safety and effectiveness of an investigational aqueous implant for lowering intraocular pressure in glaucoma patients undergoing cataract surgery, a prospective, multicenter, randomized, controlled clinical trial.

February 2014- Present

Ivantis, Inc.

 

Cataract Surgery

A phase 3, multi-center, double masked, vehicle-controlled, randomized, parallel-group study to assess investigative ophthalmic gel, 0.38% (BID and TID) versus vehicle gel for the treatment of ocular inflammation and pain following cataract surgery.

February 2014- August 2014

Bausch & Lomb

 

Dry Eye Disease

A randomized, multi-center, parallel-group safety and efficacy study of investigational ophthalmic gel 0.5% and ophthalmic solution 0.05% for 12 weeks in subjects with mild or moderate Keratoconjunctivitis Sicca.

May 2013 - June 2014

Bausch & Lomb

 

Dry Eye Disease

A phase 3, multicenter, randomized, double-masked and placebo-controlled study evaluating the efficacy of a 5.0% concentration of investigational ophthalmic solution compared to placebo in subjects with dry eye currently using artificial tears.

December 2012- October 2013

Shire

IQVIA (Quintiles)

Dry Eye Disease

A dose ranging study to evaluate safety and efficacy of investigational ophthalmic solution in dry eye disease.

December 2011- December 2012

Bausch & Lomb

 

Cataract Surgery

Efficacy of investigational ophthalmic solution in patients undergoing cataract surgery.

May 2011- December 2011

Bausch & Lomb

 

Dry Eye Disease

Efficacy and safety study of investigational ophthalmic solution 1% / 0.2% fixed combination TID vs. other investigational products, TID.

March 2011- March 2012

Alcon Research

 

Cataract Surgery

Efficacy and Safety of investigational ophthalmic solution cataract surgery.

June 2008- November 2008

Bausch & Lomb

 

Dry Eye Disease

Study of investigational ophthalmic solution in the treatment of dry eye syndrome.

October 2007- June 2011

Sirion Therapeutics Inc.

 

Glaucoma

A study of safety and IOP-lowering efficacy of investigational ophthalmic solution in patients with open-angle glaucoma.

March 2007- August 2007

Alcon Research

 

Glaucoma

Investigational ophthalmic solution as first line therapy to reduce intraocular pressure in patients with untreated open-angle glaucoma or ocular hypertension.

May 2006- August 2007

Merck & Co., Inc.

 

Glaucoma and Cataract Surgery

A study of an investigational implanted stent in combination with cataract surgery in open-angle glaucoma subjects.

June 2005- March 2010

Glaukos Corporation

 

Presbyopia

A prospective, multicenter clinical trial of an investigational scleral implant for the improvement of near visual acuity in presbyotic patients.

December 2003- March 2015

Refocus Group

 

Cataract Surgery

Efficacy and safety of an investigational topical ophthalmic solution, 0.09% vs. placebo for treatment of ocular inflammation following cataract surgery.

May 2003- August 2004

Bausch & Lomb

 

Corneal Erosion

Investigational topical ophthalmic solution in treating recurrent corneal erosion.

September 2001- August 2004

FDA Office of Orphan Products Development

 

Dry Eye Disease

Effects of investigational ophthalmic solution on aqueous dynamics.

January 2001

Allergan, Inc.

 

Glaucoma/ Ocular Hypertension

A 6-month, randomized, double-masked comparison of fixed combination of investigational products with the individual components, continuing into a 6-month open label safety study of fixed combination in patients with glaucoma or ocular hypertension.

August 1997- June 1999

Pfizer, Inc.

 

Other Clinical Trial Involvement

 

Provider of ophthalmic exams, in accordance with protocol guidelines, for subjects enrolled in numerous cancer clinical trials at a major cancer institute.

2014- Present