Clinical Trials Resource Center

New Medical Therapies™


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March 23, 2015

Ocular Therapeutix reported results of a phase III study of OTX-DP (Sustained Release Dexamethasone) for ocular inflammation and pain following cataract surgery. The multicenter, randomized, parallel-arm, double-masked, vehicle-controlled study enrolled 247 patients randomized 2:1 to receive either OTX-DP or a placebo vehicle control punctum plug without active drug. 33.7% of OTX-DP-treated patients showed an absence of inflammatory cells in the anterior chamber of the study eye on day 14 following drug product insertion, compared to 14.6% of those receiving placebo vehicle control punctum plug (p=0.0015). In addition, 76.1% of patients receiving OTX-DP reported absence of pain in the study eye on day 8 following insertion of the drug product, compared to 36.1% of those receiving placebo vehicle control punctum plug (p<0.0001). Ocular is continuing to analyze the safety findings from the clinical trial. The company is on track to submit an NDA to the FDA for OTX-DP for post-surgical ocular inflammation and pain in the second quarter of 2015.

October 10, 2011

InSite Vision reported results from a phase II trial of BromSite, their low dose formulation of bromfenac for the reduction of pain and inflammation associated with ocular surgery. This randomized, double-masked, two-arm study was designed to compare the tissue penetration profile of BromSite versus Bromday, a high dose of bromfenac and the current standard of care. The trial enrolled 58 subjects who were dosed two days before and the morning of the day of cataract surgery. Study results showed that the mean concentration of bromfenac in the aqueous humor of subjects in the BromSite group was more than twice greater compared to subjects in the Bromday group (p≡0.0032).

August 17, 2009

Omeros reported positive results from a phase I/II trial of OMS302 for the maintenance of mydriasis and the treatment of postoperative pain following cataract surgery. This randomized, double-blind, vehicle-controlled and parallel-assigned study enrolled 60 subjects undergoing age-related cataract extraction with lens replacement. The subjects were placed in one of three treatment arms: in the first arm, OMS302 including both the mydriatic and anti-inflammatory agents was added to a standard irrigation solution used in ophthalmologic surgery and delivered directly to the eye during the operation; in the second arm, subjects received irrigation solution including only the mydriatic agent, and in the third arm, subjects received standard irrigation solution only. The effects of OMS302 on dilation of the pupil during cataract surgery and on pain, discomfort and inflammation following the procedure were analyzed for 14 days. The subjects treated with OMS302 reported less postoperative pain and demonstrated statistically significant improvement in maintenance of mydriasis during the surgical procedure compared to subjects treated with placebo control. There were no serious adverse events and no discontinuations due to adverse events.

February 12, 2007

ISTA reported positive preliminary results from a phase III trial of Xibrom once daily for the treatment of pain and inflammation following cataract surgery. This randomized, double-blind, placebo-controlled trial enrolled 500 subjects who received Xybrom or placebo following cataract surgery. Treatment was well tolerated with a safety profile consistent with the currently marketed twice daily formulation of Xibrom. In addition, preliminary analysis has revealed statistical significance in the efficacy of Xibrom for treating these conditions. Pending positive final results, ISTA plans to file a sNDA in the second half of 2007.

November 1, 2004

GenVec reported positive results of a phase I trial of AdPEDF in patients with wet age-related macular degeneration (AMD) at the Subspecialty Retina Day symposium of the first joint session of the American Academy of Ophthalmology and the European Ophthalmology Society. Trial data met the primary safety and tolerability endpoints, with no dose-limiting toxicities, serious adverse events, or treatment-related infections. Secondary evidence of efficacy was also noted, with observed improvements in appearance of retinal health and stabilization of visual acuity. This open-label, dose escalating study enrolled 28 AMD patients into one of 8 dosing cohorts across six US sites. GenVec announced plans to investigate the drug in patients with less severe AMD to investigate efficacy.

ISTA Pharmaceuticals presented combined the results of a pair of phase III trials of Xibrom (bromefac sodium ophthalmic solution), for the treatment of ocular inflammation, eye pain and photosensitivity following cataract surgery. The combined data from the two trials (both conducted under the same protocol) indicated that a significantly larger portion of patients treated with Xibrom met the primary efficacy endpoint compared with placebo, as measured by the incidence of patients with complete absence of ocular inflammation at the end of the dosing period (64% vs. 40%; p<0.0001). Additional evidence of rapid, three day efficacy was also observed, and the Xibrom group experienced a lower incidence of adverse events than the placebo group. The randomized, double-blind, placebo-controlled studies enrolled a total of 527 subjects across 39 US sites, who received either topical Xibrom or placebo twice daily for 14 days, following surgical cataract removal.

Lilly has issued the results of a pair of analyses of two phase III trials of their investigational compound ruboxistaurin, for the treatment of diabetic macular edema (DME). Combined trial data indicated that the drug was efficacious in treating DME, promoting better visual acuity compared with subjects with similar degrees of macular damage receiving placebo, as measured by the number of correctly identified letters (71 vs. 60, p<0.01). In addition, a trend towards reduced DME progression was observed in subjects with significant degeneration near but not directly involving the macula, compared with placebo (20% vs. 31%, p=0.083). Both phase III trials were double-blind, long term investigations (30 and 36 month minimum durations), and enrolled more than 900 patients with DME. Lilly announced that these analyses would be used to support an ongoing phase III trial of the drug.

May 13, 2002

Phase II trial results suggest that CAT-152 is safe and well tolerated in subjects undergoing surgery for glaucoma and cataract. In the trial, 56 subjects were randomized to receive either CAT-152 or placebo on the day of surgery, the day after surgery and a week after surgery. After 12 months, subjects treated with CAT-152 achieved lower IOP (14.4 mmHg mean value) than those receiving placebo (16.9 mmHg mean value). One hundred percent of CAT-152-treated subjects versus 85% of placebo-treated subjects achieved IOP below 22 mmHg. Additionally, four of 36 subjects receiving CAT-152 (11%) required topical medication to manage their IOP, compared to four of 20 subjects (20%) in the placebo group. CAT-152 is being developed by Cambridge Antibody Technology.

This information does not represent a Lupus Research Institute endorsement of any listed study. It is merely a notice that the study is available. If you are presently under the care of a physician for lupus or other conditions, you should not disrupt your current program without discussing it with your doctor(s). Do not contact the Lupus Research Institute for information on these studies. Only contact the listed numbers. The Lupus Research Institute does not have any jurisdiction over or further involvement with these studies, other than to make people aware that they are being conducted.