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Purpose: To assess the safety and efficacy of a ciliary neurotrophic factor (CNTF) intraocular implant on neuroprotection and neuroenhancement in glaucoma. Design: Open-label, prospective, phase I clinical trial. Participants: A total of 11 participants were diagnosed with primary open-angle glaucoma (POAG). One eye of each patient was assigned as the study (implant) eye. Methods: The study eye was implanted with a high-dose CNTF-secreting NT-501 implant, whereas the other eye served as a control. All patients were followed up for 18 months. Analysis was limited to descriptive statistics. Main Outcome Measures: Primary outcome was safety through 18 months after implantation assessed by serial eye examinations, structural and functional testing, and adverse events (AEs) recording. Parameters measured included visual acuity (VA), Humphrey visual field (HVF), pattern electroretinogram, scanning laser polarimetry with variable corneal compensation (GDx VCC), and OCT. These parameters were also used for secondary analysis of efficacy outcome. Results: All NT-501 implants were well tolerated with no serious AEs associated with the implant. The majority of AEs were related to the implant placement procedure and were resolved by 12 weeks after surgery. Foreign-body sensation was the most commonly reported AE and was self-limited to the postoperative period. The most common implant-related AE was pupil miosis; no patients underwent explant. Visual acuity and contrast sensitivity decreased more in fellow eyes than in study eyes (VA, −5.82 vs. −0.82 letters; and contrast sensitivity, −1.82 vs. −0.37 letters, for fellow vs. study eyes, respectively). The median HVF visual field index and mean deviation measurements worsened (decreased) in fellow eyes (−13.0%, −3.9 dB) and improved (increased) in study eyes (2.7%, 1.2 dB). Implanted eyes showed an increase in retinal nerve fiber layer thickness measured by OCT and by GDx VCC (OCT, 2.66 μm vs. 10.16 μm; and GDx VCC, 1.58 μm vs. 8.36 μm in fellow vs. study eyes, respectively). Conclusions: The NT-501 CNTF implant was safe and well tolerated in eyes with POAG. Eyes with the implant demonstrated both structural and functional improvements suggesting biological activity, supporting the premise for a randomized phase II clinical trial of single and dual NT-501 CNTF implants in patients with POAG, which is now underway. Financial Disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

A fast and simple fluorimetric method is described for the simultaneous determination of ampicillin and tetracycline in milk by combining the stopped-flow mixing technique with a T-format spectrofluorimeter. Ampicillin determination is based on its hydrolysis with penicillinase and reaction with mercuric chloride, while the intramolecular energy transfer from tetracycline to europium ions in the presence of thenoyltrifluoracetone is used for tetracycline determination. The similar excitation wavelengths of both systems and the separation between the corresponding emission wavelengths allow the direct determination of both analytes by measuring simultaneously the initial rate of the ampicillin system and the equilibrium signal of the tetracycline system. The relative standard deviations were lower than 2%. The proposed method was applied to the determination of these antibiotics in different milk samples with a recovery of 95.0-103.3% for ampicillin and 93.3-103.3% for tetracycline.

The use of Cresyl Violet and sodium dodecyl sulphate for the kinetic fluorimetric determination of lysozyme from dynamic fluorescence measurements at a long wavelength in the range near 600 nm was explored. The high initial rate of this system allows analytical measurements to be made within ca. 2 s after the reactants are mixed, by using the stopped-flow mixing technique, which makes the method applicable to automatic routine analysis. The calibration graph is linear over the range 0.5-40 mug ml(-1) lysozyme hydrochloride and the detection limit of 0.19 mug ml(-1). The precision is less than 2% (relative standard deviation). The results obtained by applying the proposed method to the analysis of pharmaceutical samples with no pretreatment shown how readily it can be adapted for routine analyses. Analytical recoveries ranged between 94.0 and 104.0%.