Comparison of natamycin and voriconazole for the treatment of fungal keratitis.
OBJECTIVE
To conduct a therapeutic exploratory clinical trial comparing clinical outcomes of treatment with topical natamycin vs topical voriconazole for fungal keratitis.


METHODS
The multicenter, double-masked, clinical trial included 120 patients with fungal keratitis at Aravind Eye Hospital in India who were randomized to receive either topical natamycin or topical voriconazole and either had repeated scraping of the epithelium or not.


METHODS
The primary outcome was best spectacle-corrected visual acuity (BSCVA) at 3 months. Other outcomes included scar size, perforations, and a subanalysis of BSCVA at 3 months in patients with an enrollment visual acuity of 20/40 to 20/400.


RESULTS
Compared with those who received natamycin, voriconazole-treated patients had an approximately 1-line improvement in BSCVA at 3 months after adjusting for scraping in a multivariate regression model but the difference was not statistically significant (P = .29). Scar size at 3 months was slightly greater with voriconazole after adjusting for scraping (P = .48). Corneal perforations in the voriconazole group (10 of 60 patients) were not significantly different than in the natamycin-treated group (9 of 60 patients) (P >.99). Scraping was associated with worse BSCVA at 3 months after adjusting for drug (P = .06). Patients with baseline BSCVA of 20/40 to 20/400 showed a trend toward a 2-line improvement in visual acuity with voriconazole (P = .07).


CONCLUSIONS
Overall, there were no significant differences in visual acuity, scar size, and perforations between voriconazole- and natamycin-treated patients. There was a trend toward scraping being associated with worse outcomes. Application to Clinical Practice The benefit seen with voriconazole in the subgroup of patients with baseline visual acuity of 20/40 to 20/400 needs to be validated in a confirmatory clinical trial. Trial Registration clinicaltrials.gov Identifier: NCT00557362.
Prajna
Namperumalsamy V
NV
Aravind Eye Care System, Madurai, India.
Mascarenhas
Jeena
J
Krishnan
Tiruvengada
T
Reddy
P Ravindranath
PR
Prajna
Lalitha
L
Srinivasan
Muthiah
M
Vaitilingam
C M
CM
Hong
Kevin C
KC
Lee
Salena M
SM
McLeod
Stephen D
SD
Zegans
Michael E
ME
Porco
Travis C
TC
Lietman
Thomas M
TM
Acharya
Nisha R
NR
D000287:Administration, Topical; D000891:Anti-Infective Agents, Local / Q000627:therapeutic use*; D000935:Antifungal Agents / Q000627:therapeutic use*; D003315:Cornea / Q000382:microbiology; D003320:Corneal Ulcer / Q000188:drug therapy* / Q000382:microbiology / Q000503:physiopathology; D004311:Double-Blind Method; D015821:Eye Infections, Fungal / Q000188:drug therapy* / Q000382:microbiology / Q000503:physiopathology; D005260:Female; D005658:Fungi / Q000302:isolation & purification; D006801:Humans; D008297:Male; D008875:Middle Aged; D009181:Mycoses / Q000188:drug therapy* / Q000382:microbiology / Q000503:physiopathology; D010866:Natamycin / Q000627:therapeutic use*; D009883:Ophthalmic Solutions; D011743:Pyrimidines / Q000627:therapeutic use*; D016896:Treatment Outcome; D014230:Triazoles / Q000627:therapeutic use*; D014792:Visual Acuity / Q000502:physiology; D065819:Voriconazole
D000891:Anti-Infective Agents, Local; D000935:Antifungal Agents; D009883:Ophthalmic Solutions; D011743:Pyrimidines; D014230:Triazoles; D010866:Natamycin; D065819:Voriconazole