Poster 75: Safety and Efficacy of 0.3% Gatifloxacin as Compared with 0.3% Ciprofloxacin for the...
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Transcript of Poster 75: Safety and Efficacy of 0.3% Gatifloxacin as Compared with 0.3% Ciprofloxacin for the...
![Page 1: Poster 75: Safety and Efficacy of 0.3% Gatifloxacin as Compared with 0.3% Ciprofloxacin for the Treatment of Acute Bacterial Corneal Ulcers](https://reader031.fdocuments.us/reader031/viewer/2022020613/575091461a28abbf6b9ce5ee/html5/thumbnails/1.jpg)
Results: Study 1—A significant reduction in corneal stain-ing change from baseline for the new Concept Tear (p �0.05) was found at 6 weeks vs. CMC 0.5% Multi-dose, witha trend in favor of the concept tear (p � 0.07) vs. the UnitDose. A significant reduction from baseline in symptomswas observed for all products tested. Study 2—Drop com-fort was similar, but there was a significant differencefavoring the Concept Tear (p � 0.0008) in drop acceptabil-ity with significantly less blurring (p � 0.0001) vs. CMC1% tear.Conclusions: These studies showed that the new ConceptTear demonstrated statistically significant reductions in cor-neal staining in a 6-week study and was more acceptable,with less blurring in an acute evaluation, than the controls.(Investigators are all employees of Alcon Laboratories.)
Poster 74
Calcific Band KeratopathyPhilip Do, O.D., and Steven Ferrucci, O.D. Dr. Do iscurrently in private practice at 10733 East ArrowheadStreet, Temple City, California 91780, Dr. Ferrucci atSepulveda VA Ambulatory Care Center and NursingHome, 16111 Plummer Street, North Hills, California91343
Background: Calcific band keratopathy is a condition that ischaracterized by deposition of calcium between the subepi-thelium and Bowman’s layer of the cornea. Its clinicalappearance is typically bilateral and is described as hazy/gray-white plaques with transparent holes that resemble“Swiss cheese.” It is usually located in the interpalpebralzone, but can spread centrally across the cornea. Patientswith band keratopathy can either be asymptomatic or reportforeign body sensation and possibly decreased vision if thelesion spreads across the visual axis. Treatment and man-agement depend on the severity of the condition; withmilder cases involving persistent irritation, it is recom-mended to vigorously lubricate the eyes with artificial tearsand/or ointment. In moderate or severe cases with obstruc-tion to vision, corneal debridement with topical chelatingagent EDTA is used.Case Report: A 66 year-old man initially came to us witha report of decreased vision for reading fine print anddry/irritated eyes O.D. �� O.S. His best-corrected visualacuities were 20/25 O.D. and 20/25 O.S. Slit-lamp ex-amination revealed gray subepithelial corneal depositsinferiorly in an arcuate pattern O.D. �� O.S. The patientwas diagnosed with Calcific band keratopathy O.D. ��O.S. and was put on a regimen of artificial tears andlacrilube ointment.Conclusion: Calcific band keratopathy is a fairly commoncondition that can present in clinical practice. Once diag-nosed, mild cases of dry eyes/irritation can be managed withlubricating regimen of artificial tears and ointment. In mod-erate-to-severe conditions of band keratopathy spreadingacross the visual axis causing decrease vision, corneal
debridement in conjunction with EDTA is indicated. Inaddition, one needs to consider the etiology of the condition,with possible systemic relations to hyperparathyroidism,hypervitaminosis D, chronic renal failure, sarcoidosis, andmetastatic neoplasia.
Poster 75
Safety and Efficacy of 0.3% Gatifloxacin as Comparedwith 0.3% Ciprofloxacin for the Treatment of AcuteBacterial Corneal UlcersKelly Nichols, O.D., M.P.H., Ph.D.,Ching-Chi (Rebecca) Liu, Harold Jensen, Ph.D.,William Davitt, M.D., Stefan Trocme, M.D.,Rasik Vajpayee, M.D., Venkatesh Prajna, M.D., andEleonora Safyan, B.S., The Ohio State University, Collegeof Optometry, 338 West Tenth Avenue, Columbus, Ohio43210
Background: This study evaluated the safety and efficacy of0.3% gatifloxacin as compared with 0.3% ciprofloxacin(chosen as the comparator due to its established efficacy forgram-negative infections) in the treatment of acute bacterialcorneal ulcers.Methods: In this multicenter, investigator-masked study,patients with acute bacterial corneal ulcers (�1 mm diam-eter) in 1 eye were randomized to receive 0.3% gatifloxacin(n � 37) or 0.3% ciprofloxacin (n � 38). Day 0 dosing was1 drop every 5 minutes for 30 minutes, followed by 1 dropevery 30 minutes while awake and 1 drop every 2 hoursafter retiring. Day 1 dosing was 1 drop every hour whileawake and 1 drop every 4 hours after retiring. Dosing was1 drop every 2 hours while awake for Days 2 through 6 and1 drop q.i.d. while awake for Days 7 to 21. Dosing wasterminated when re-epithelialization was complete, patientswithdrew from the study, or on Day 28. The primaryefficacy analysis was based on patients with positive bac-terial cultures (modified intent-to-treat population).Results: The percentage of patients reaching complete re-epithelialization was higher in the gatifloxacin group thanthe ciprofloxacin group at Day 11 [81.1% (30/37) vs. 52.6%(20/38), (P � 0.009)]; Day 14 [86.5% (32/37) vs. 60.5%(23/38), (P � 0.011)]; and Day 21 [89.2% (33/37) vs. 76.3%(29/38), (P � 0.141)]. A statistically significantly greaterpercentage of patients in the gatifloxacin group were ratedas cured in the investigator’s evaluation at Day 14 (P �0.032). There was no statistically significant differencebetween the 2 treatment groups in change from baseline inthe area of epithelial healing (at any time during the study)or in the rate of adverse events.Conclusion: Administration of 0.3% gatifloxacin is safe andeffective in the treatment of acute bacterial corneal ulcers.Patients with acute bacterial ulcers treated with 0.3% gati-floxacin were observed to have complete healing at earlierfollow-up visits than did those treated with 0.3% ciprofloxa-cin. (This study was sponsored by Allergan, Inc.)
295Poster Presentations