Cornea - ARVO

ARVO 2013 Annual Meeting Abstracts by Scientific Section/Group - CorneaCommercial Relationships: Lynne S. Gearinger, Bausch & Lomb,Inc. (E); Christine M. Sanfilippo, Bausch & Lomb, Inc. (E); LeningZhang, Bausch + Lomb (E); Wolfgang Haas, Bausch & Lomb, Inc.(E); Timothy L. Comstock, Bausch & Lomb Incorporated (E);Timothy W. Morris, Bausch & Lomb, Inc. (E)Clinical Trial: NCT01175590Program Number: 5451 Poster Board Number: A0150Presentation Time: 8:30 AM - 10:15 AMA Parallel-Group Study Evaluating the Safety and Efficacy ofBrimonidineTartrate 0.025% Ophthalmic Solution in aPopulation of Adult and Geriatric SubjectsGerald Horn 1 , Matt J. Chapin 2 , Paul J. Gomes 2 . 1 Eye Therapeutics,Schaumburg, IL; 2 Ora, Inc, Andover, MA.Purpose: Vasoconstrictors are currently the most widely usedophthalmic drop. Longer lasting, more effective agents withimproved safety and reduced rebound are needed.Methods: This study employed a single-center, double-masked,randomized, vehicle - controlled, parallel-group design to evaluatethe safety and efficacy of brimonidine tartrate 0.025% ophthalmicsolution versus vehicle in a population (N=57) of adult (> 40 years ofage) and geriatric (> 65 years of age) subjects dosed QID for 4weeks. Subjects were randomized without age stratification to receiveeither brimonidine or vehicle. Following instillation of testcompound, subjects scored the drop for comfort (0-10 scale)immediately, and again 1 and 2 minutes after instillation. Ocularredness was then scored by the investigator at 5, 15, 30, 60, 90, 120,180, and 240 minutes after medication instillation (0-4 scale, .5 unitincrements). Subjects were then sent home with instructions to recordocular redness scores before and 2 minutes after each of the 4 dailydoses. In addition, they were instructed that the interval betweendoses should be no less than 3.5 hours. Diaries were collected after 2weeks and again after 4 weeks.Results: Subjects reported a high degree of comfort with both thebrimonidine drop (mean comfort 0.7±1.48 for all scores) and thevehicle (0.4±1.24). Adverse events were minimal in both groups. Inthe time course of redness scores recorded after the 1st instillation,the brimonidine-treated group were both clinically and statisticallysuperior to the vehicle treated group at all time points. Thedifferences between pre- and post-instillation readings for thebrimonidine group diary scores were also significant, while those ofthe vehicle group were not.Conclusions: Brimonidine 0.025% was effective in reducing ocularredness both in office assessments by a clinician and in subjectivediary assessments. Onset of action was rapid (within 5 minutes), andfor 4 weeks in an adult population aged 40 years and older (includinggeriatrics) was tolerable and safe. The drops were very comfortable,and there is no indication of any redness rebound or drug-inducedhypersensitivity issues.Commercial Relationships: Gerald Horn, Alpha Synergy Corp (I),Alpha Synergy Corp (P), Alpha Synergy Corp (S); Matt J. Chapin,Ora, Inc. (E); Paul J. Gomes, Ora, Inc. (E)Clinical Trial: NCT01675609Program Number: 5452 Poster Board Number: A0151Presentation Time: 8:30 AM - 10:15 AMEvolution in post transplant patients with Herpetic Keratitis inHospital Fundacion Nuestra Señora de la Luzcristina C. fernandez 1 , Cristina Pacheco-Del-Valle 2 , AlejandroBabayan 3 , Oscar Baca 4 , Regina Velasco 5 . 1 cornea, HospitalFundacion Nuestra Señora de la Luz, Distrito Federal, Mexico;2 cornea, Hospital Fundacion Nuestra Señora de la Luz, DistritoFederal, Mexico; 3 cornea, Hospital Fundacion Nuestra Señora de laLuz, Distrito Federal, Mexico; 4 cornea, Hospital Fundacion NuestraSeñora de la Luz, Distrito Federal, Mexico; 5 cornea, HospitalFundacion Nuestra Señora de la Luz, Distrito Federal, Mexico.Purpose: The Herpes Simplex Virus is a common cause of cornealpathology, being the leading cause of infectious blindness corneal indeveloped countries. The recurrence rate is high. Periodic reactivationsin the cornea are particularly important because thecumulative effect of the reinfection can lead to scarring orperforation, being an etiologic diagnosis common in patients who areundergoing penetrating keratoplasty. The objective of this study wasto assess the evolution in patients with herpetic keratitis penetratingkeratoplasty and identify the factors that could influence the cornealrejection.Methods: An observational retrospective study that reviewed therecords of 36 patients in the Fundacion Hospital NuestraSeñora de laLuz was conducted. Factors were analyzed such as indication of thesurgical procedure, procedure, treatment pre surgical and postsurgicalwith acyclovir dosage and administration time, date in whichthe surgery was carried out, presence or not of activity at the time ofsurgery, outcome 3 years specifically the presence of rejection,failure or success at the time of the last review.Results: From December 2009 to December 2011 we reviewed 36records of 36 patients who underwent penetrating keratoplasty forherpetic keratitis. The patient age at surgery was 35.05 years, 22 werewomen and 13 men, 4 patients received preoperative treatment withacyclovir, 32 did not. The average treatment dose was 400 mg every12 hours and the average time was 8.5 months. As pos operativetreatment 22 received acyclovir and 14 did not, being theprophylactic dose of 200 mg every 12 hours average and thetherapeutic dose of 400 mg every 12 hours, with an average of 9.63months, 14 patients had no rejection and 22 had at least one episode ,9 of which came to failure in average 21.88 months after surgery, 6of these 9 cases were treated with pre operative acyclovir and 3 werenot.Conclusions: We conclude that the population with herpetic keratitiscan gain Visual benefits with a penetrating keratoplasty. Howeverthere are factors that can affect the prognosis and that should be takeninto account for best results.Commercial Relationships: cristina C. fernandez, None; CristinaPacheco-Del-Valle, None; Alejandro Babayan, None; Oscar Baca,None; Regina Velasco, NoneSupport: none in the support fieldthe duration of action ≥ 4 hours. QID dosing of brimonidine 0.025%©2013, Copyright by the Association for Research in Vision and Ophthalmology, Inc., all rights reserved. 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