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Bleph-10 (Sulfacetamide Sodium Ophthalmic) - Summary



BLEPH®-10 (sulfacetamide sodium ophthalmic solution, USP) 10% is a sterile, topical anti-bacterial agent for ophthalmic use.

BLEPH®-10 solution is indicated for the treatment of conjunctivitis and other superficial ocular infections due to susceptible microorganisms, and as an adjunctive in systemic sulfonamide therapy of trachoma: Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species.

Topically applied sulfonamides do not provide adequate coverage against Neisseria species, Serratia marcescens and Pseudomonas aeruginosa. A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.

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Published Studies Related to Bleph-10 (Sulfacetamide Ophthalmic)

Combination sodium sulfacetamide 10% and sulfur 5% cream with sunscreens versus metronidazole 0.75% cream for rosacea. [2005.06]
Topical metronidazole and combination sodium sulfacetamide and sulfur commonly are used to treat rosacea. Recently, the relative efficacy and safety of sodium sulfacetamide 10% and sulfur 5% cream with sunscreens (Rosac Cream) (n = 75) and metronidazole 0.75% cream (Metrocream) (n = 77) were compared in an investigator-blinded, randomized, parallel-group study at 6 sites...

The multifunctionality of 10% sodium sulfacetamide, 5% sulfur emollient foam in the treatment of inflammatory facial dermatoses. [2010.03]
Prior to 1962, some of the most versatile drugs in dermatology were approved by the U.S...

Sulfacetamide loaded Eudragit(R) RL100 nanosuspension with potential for ocular delivery. [2010]
PURPOSE: Polymeric nanosuspension was prepared from an inert polymer resin (Eudragit(R) RL100) with the aim of improving the availability of sulfacetamide at the intraocular level to combat bacterial infections... CONCLUSION: The results indicate that the formulation of sulfacetamide in Eudragit(R) RL100 nanosuspension could be utilized as potential delivery system for treating ocular bacterial infections.

Treatment of papulopustular rosacea with sodium sulfacetamide 10%/sulfur 5% emollient foam. [2009.03]
Acne rosacea is a chronic cutaneous disorder affecting as many as 14 million Americans.The high patient satisfaction ratings for SSSE foam suggest that the product may improve long-term compliance rates, with the potential to yield more favorable clinical outcomes.

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Clinical Trials Related to Bleph-10 (Sulfacetamide Ophthalmic)

Effects of Hyperbaric Oxygen Therapy on Surgical Wound Healing [Enrolling by invitation]
The aim of this study is to test the effect of Hyperbaric Oxygen Therapy) HBOT (100% oxygen; 2. 0 ATA; 90 minute total exposure) and compare against a hyperbaric sham treatment (HBST) (patient's breathing room air; 2. 0 ATA; 90 minute exposure) in reducing edema and ecchymosis. HBOT will be applied as a single pre-operative and a single post-operative treatment for patients undergoing eyelid surgery. Briefly, patients will be exposed to HBOT 2-4 hours prior to undergoing surgery, 2-4 hours post-surgery and healing will be assessed at day 3, 10, 21, 30 & 90 days after surgery. Edema and ecchymosis will be assessed in a time series to determine the extent that HBOT reduces these clinical signs. The primary null hypothesis to test will be that no differences in scores will exist between treatment and control at day 3, 10 & 21 post-surgery. A secondary null hypothesis to test is the time required to change a score will be no different between the two groups. HBOT=hyperbaric oxygen therapy; HBST=hyperbaric sham treatment

Patients Response to Early Switch To Oral:Osteomyelitis Study [Not yet recruiting]
Based on the current literature, investigators hypothesize that patients with osteomyelitis who are treated with the standard approach of intravenous antibiotics for the full duration of therapy will have the same clinical outcomes as patients treated with the experimental approach of intravenous antibiotics with early switch to oral antibiotics. The primary objective of this study is to compare patients with osteomyelitis treated with the standard approach of intravenous antibiotics for the full duration of therapy versus patients treated with intravenous antibiotics with an early switch to oral antibiotics in relation to clinical outcomes at 12 months after discontinuation of antibiotic therapy. Secondary objectives of the study include the evaluation of adverse events related to the use of antibiotics as well as the cost of care evaluated from the hospital perspective.

Intraductal Meibomian Gland Probing Trial [Active, not recruiting]
In this research study, the investigators are looking at the effects of Meibomian Gland Probing (MGP) versus a sham (fake) procedure in patients with refractory MGD who have already tried traditional management with no success in resolving their clinical signs (as seen by their ophthalmologist) or their symptoms. The investigators are also evaluating the effects of using two (2) post-procedural medication treatments: Blephamide or GenTeal PM Night-Time to determine if treatment after the MGP procedure has an effect on its outcome.

Treatment of Patients With Blepharitis and Facial Rosacea [Completed]
To determine the safety and efficacy of sub-antimicrobial dose COL-101 in the treatment of patients who have both blepharitis and facial rosacea

The Effect of Sodium Thiosulfate Eardrops on Hearing Loss in Patients Who Receive Cisplatin Therapy [Terminated]
This is a pilot, randomized, self-controlled study of the effects of intratympanic sodium thiosulfate (STS) on the degree of hearing loss in patients receiving cisplatin therapy. Sodium thiosulfate is an inactive ingredient contained in sulfacetamide ophthalmic solution which is used routinely as an otic solution delivered to the middle ear space. The hypothesis of this study is that local administration of sodium thiosulfate (STS) will result in improved hearing compared to ears not receiving the study drug in patients receiving systemic cisplatin therapy.

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Page last updated: 2011-12-09

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