Study recruitment for oGvHD patients who wear scleral lenses

Hope all is well.  

I wanted to reach out regarding the clinical research study for which BostonSight is currently recruiting ocular graft versus host disease (oGvHD) patients who wear ANY type of scleral lenses. 

Patients who enroll in this study will receive Pro-ocularTM (Progesterone USP) 1% Topical Gel applied to the forehead twice daily. The study will investigate the drug’s effect on symptoms and signs of oGvHD, ocular comfort associated with scleral lens wear, and duration of effective wear time of scleral lenses.

In 2019, a Phase 2 placebo-controlled study investigating Pro-ocularTM was conducted at Mass Eye and Ear in 33 patients diagnosed with oGvHD (see attached documents). Results demonstrated drug safety and efficacy with significant improvement in patients’ disease signs and symptoms. Of the 30 surviving patients from that study, 26 remain on Pro-ocularTM treatment today in the long-term, open-label phase. 

This twelve-month study includes five in-office visits at BostonSight, Needham and two phone visits. Some patients will receive placebo treatment for three months followed by active drug treatment for three months. All other patients will receive active drug treatment for all six months. After six months, all subjects can enroll in a long-term, open label phase.

If you are interested in participation in this study, please contact Estelle Crowley, Clinical Research Coordinator at BostonSight, (781-726-7506) or ecrowley@bostonsight.org to learn more.

Please see the link below for further details:

https://clinicaltrials.gov/ct2/show/NCT04769648?cond=pro-ocular&draw=2&rank=1

Thank you! 

Daniel C. Brocks, MD
Chief Medical Officer