Our research projects are guided by our mission to improve quality of life by transforming the understanding, treatment, and care of the ocular surface.
The list below provides information about our clinical research studies. Please contact us if you are interested in participating in any studies or have any questions about our research program.
Current BostonSight Clinical Research Studies
The Effect of PROSE Treatment on Mental Health
Location of Study: BostonSight, Needham
Study Status: Actively recruiting
The goal of this prospective clinical trial is to evaluate the effect that PROSE treatment may have on mental health. Participants are required to be new patients, will complete standardized questionnaires, and will undergo a standard examination of the front surface of their eye.
Novel Use of Restasis (Cyclosporine Ophthalmic Emulsion 0.05%) on the Application of PROSE Devices for Management of Patients with Ocular Surface Disease: A Pilot Study
Location of Study: BostonSight, Needham
Study Status: No longer recruiting
The purpose of this placebo/control study is to evaluate Restasis (cyclosporine ophthalmic solution 0.05%) when added to the PROSE (Prosthetic Replacement of the Ocular Surface Ecosystem) lens reservoir in patients with ocular surface disease (OSD).
ClinicalTrials.gov site here.
12-Week Clinical Study to Evaluate a New Investigational Eye Drop for Patients Who Have Ongoing Eye Pain/Dry Eye Symptoms and Have Had Refractive or Cataract Surgery
Location of Study: BostonSight, Needham
Study Status: No longer recruiting
ClinicalTrials.gov site here.
A Phase II/III Trial of Safety and Efficacy of Pro-ocular™ 1% in Daily Scleral Lens Wearing Patients with Ocular Graft-Versus-Host Disease
Location of Study: BostonSight, Needham
Study Status: No longer recruiting
The purpose of this placebo/control study is to evaluate the safety and efficacy of Pro-ocular™ 1% cream on reducing the signs and symptoms of Ocular Graft-Versus-Host Disease. Preliminary studies have shown success in reducing signs and symptoms in patients with Ocular Graft-Versus-Host Disease.
ClinicalTrials.gov site here.
Additional Local Clinical Research Studies
Clinical Trial Comparing Two Non-Surgical Treatments for Severe Blepharoptosis
Location of Study: Massachusetts Eye and Ear
Study Status: Actively recruiting
The purpose of this study: To study two different non-surgical devices for people with ptosis (incomplete opening of the eyelid). Both devices have been designed with the purpose of giving you a larger field of vision by opening your eyelid while still allowing you to blink. By analyzing participants’ use of the two devices, in particular how much the devices help to open the eyelid and allow natural blinking, we will be able to make recommendations about which device is likely to be helpful to patients with ptosis in the future.
ClinicalTrials.gov site here.
Past Clinical Research Studies
Clinical Trial Evaluating the Safety and Efficacy of a Novel Ophthalmic Solution for Stage 2 and 3 Neurotrophic Keratitis (NK)
Location of Study: To be assigned to local site
Sponsor: Claris Biotherapeutics
Study Status: Actively recruiting
The purpose of this multi-site, randomized, double-masked, vehicle-controlled study is to evaluate the safety and efficacy of CSB-001, an investigational eye drop, in eyes with stage 2 or 3 NK. NK is a serious sight-threatening condition characterized by a corneal defect (PED or ulcer) with decreased corneal sensitivity. Subjects will dose with the randomized treatment four times daily for 8 weeks and will be seen weekly by an eye doctor.
ClinicalTrials.gov site here.
An Evaluation of Tangible Boost (Hydra-PEG) at Home Lens Coating System for Patients with Dry Eye Syndrome, Steven Johnson Syndrome, Sjögren’s Syndrome, and Graft Versus Host Disease
Location of study: BostonSight, Needham
Study status: Completed
The purpose of this study is to evaluate the effectiveness of Tangible Boost, a product designed to provide the patient with a system to monthly re-coat their PROSE lenses with Hydra-PEG at home. Patients with Dry Eye Syndrome, Stevens-Johnson Syndrome, Sjogren’s Syndrome, or Graft versus Host disease are eligible. This study is for patients who are already using the Hydra-PEG coating or who are planning to get a new lens with Hydra-PEG coating.
Pilot Study to Investigate the Feasibility, Reliability, and Efficiency of Utilizing Ocular Surface Optical Coherence Tomography to Automate PROSE Fitting
Location of Study: BostonSight, Needham
Study Status: Completed
The purpose of this study is to evaluate the feasibility, reliability and efficiency of utilizing ocular surface optical coherence tomography (ocular surface imaging) to automate the PROSE (Prosthetic Replacement of the Ocular Surface Ecosystem) fitting process. The use of this imaging technology could considerably reduce the time needed per visit, the number of visits, and the number of devices needed to be manufactured to reach the PROSE fitting endpoint.
ClinicalTrials.gov Site here.
Measuring Eye Pressure in Patients Wearing Scleral Lenses
Location of Study: BostonSight, Needham
Study Status: Completed 4/27/21
The goal of this research is to determine how well we can measure intraocular pressure (“eye pressure”) when a scleral lens is on the eye. This prospective study uses three non-invasive FDA approved methods to measure eye pressure: scleral tonopen, scleral pneumatonometry, and Diaton tonometry. Evaluating these methods of measurement may be an important step for future studies investigating and understanding risk factors for glaucoma.
ClinicalTrials.gov Site here.