Glaucoma Consultants of the Capital Region is dedicated to advancing both current and new forms of treatment for glaucoma. We have participated in numerous national studies to evaluate and treat all forms of glaucoma. We believe that clinical research will help advance treatment for glaucoma and help to prevent vision loss from this disease.
Glaucoma is a progressive optic neuropathy that causes loss of visual fields and can eventually lead to blindness. Several clinical studies have supported the need for improved efficacy of glaucoma medications. To delay disease progression, every millimeter of reduction in intraocular pressure is significant. Thus the goal for treating patients should be to lower the intraocular pressure, to the point that it prevents further damage to the optic nerve. The information that is obtained during clinical studies is extremely beneficial to making advances in glaucoma treatment for the future.
AR-13324-CS302 ROCKET 2
Inhibitors of Rho Kinase (ROCK) have emerged as a new class of potential glaucoma medications and are currently being investigated in our office. AR-13324 ophthalmic solution is a novel Rho Kinase and norepinephrine transporter inhibitor developed by Aerie Pharmaceuticals, Inc. AR-13324 ophthalmic solution appears to reduce intraocular pressure through a dual mechanism of action. In addition to increasing outflow facility through ROCK inhibition at the trabecular meshwork, topical ocular administration of AR-13324 ophthalmic solution decreases production of aqueous humor.
The objective of this study is to evaluate the efficacy of AR-13324 ophthalmic solution over a period of 12 months in patients with a diagnosis of Open Angle Glaucoma or Ocular Hypertension, who are currently using no more than 2 ocular hypotensive medications. The study subject will be required to instill AR-13324 ophthalmic solution twice a day in each eye. One drop will be instilled in the morning between 7:30 am and 8:30 am, and in the evening between 8:00 pm and 10:00 pm. The study will consist of 9 visits over the 12 month period. The visits will include; screening visit, qualification #1 visit (8:00 am), qualification #2/Day 1 visit (8:00 am, 10:00 am and 4:00 pm), Week 2/Day 15 visit (8:00 am, 10:00 am and 4:00 pm), Week 6/Day 43 visit (8:00 am, 10:00 am and 4:00 pm), Month 3/Day 90 visit (8:00 am, 10:00 am and 4:00 pm), Month 6/Day 180 visit (8:00 am), Month 9/Day 270 visit (8:00 am), and Month 12/Day 365 visit (8:00 am). The study visits will involve reviewing current medications, vitals, visual acuity, and assessment of intraocular pressure.
PPL GLAU M1
The objective of this study is to evaluate the efficacy, safety and duration of effect of two configurations of L-PPDS (Latanoprost Punctal Plug Delivery System) compared to Timolol Maleate GFS 0.5% Ophthalmic Solution. Punctal occlusion increases the therapeutic index of topical hypotensive agents by (1) decreasing systemic absorption of the topically applied agent, while (2) increasing tear retention time, thereby enhancing ocular drug absorption and interaction with target receptors. The study will assess patients with a diagnosis of Open Angle Glaucoma or Ocular Hypertension over a period of 14 weeks, who are currently being treated with a topical prostaglandin and up to one additional ocular hypotensive medication.
Once eligibility is determined, subjects will be randomly assigned to treatment for 14 weeks in one of four groups.
*Group A. L-PPDS continuous single occlusion. L-PPDS will be inserted in the lower punctum of each eye and no plugs will be inserted into the upper punctum of each eye; will remain for a period of 14 weeks.
*Group B. L-PPDS continuous double occlusion. L-PPDS will be inserted in the lower punctum of each eye and non-therapeutic plugs will be inserted in the upper punctum of each eye and both will remain for a period of 14 weeks.
*Group C. L-PPDS re-insertion. L-PPDS will be inserted in the lower punctum of each eye and non-therapeutic plugs will be inserted in the upper punctum of each eye. The L-PPDS punctal plugs will remain for a period of 12 weeks. At week 12, after the final intraocular pressure measurement, the L-PPDS plugs will be replaced and will remain for 2 weeks.
*Group D. Timolol Maleate GFS drops. One drop in both eyes of Timolol Maleate GFS 0.5% Ophthalmic Solution will be instilled by the study subject at home every morning for 14 weeks.
Study subjects will be followed for assessments of safety and intraocular pressure reduction over the 14 week period. Study visits will involve reviewing current medications, vitals, visual acuity, and assessment of intraocular pressure. The study visits will include; screening visit, post washout/Day -2 visit, baseline/Day 0 visit, Day 1 visit, Week 2 visit, Week 4 visit, Week 8 visit, Week 10 visit, Week 12 visit, Week 13 visit, and Week 14 visit. For the baseline/Day 0 visit, Day 1 visit, Week 2 visit, Week 8 visit and Week 12 visit, intraocular pressure will be measured in the early morning between 7:00 am and 9:00 am, in the late morning approximately 2 1/2 hours after the early morning measurement, in the early afternoon approximately 5 1/2 hours after the early morning measurement, and then in the late afternoon at approximately 8 1/2 hours after the early morning measurement. During Week 4, Week 10, Week 13, and Week 14, intraocular pressure will be measured in the early morning between 7:00 am and 9:00 am and then in the late morning approximately 2 1/2 hours after the early morning measurement. Intraocular pressure is not measured in the afternoon during these visits. For the study subjects that are randomized into the groups which will require insertion of the L-PPDS, the L-PPDS plugs and non-therapeutic plugs will be placed after the late afternoon intraocular pressure measurement at the baseline/Day 0 visit.