A phase III, multicenter, randomized, placebo-controlled clinical trial of topical aminocaproic acid (Caprogel) in the management of traumatic hyphema.
OBJECTIVE
To determine the safety and efficacy of topical aminocaproic acid (Caprogel) in the management of traumatic hyphema.


METHODS
Multicenter, randomized, double-masked, placebo-controlled clinical trial.


METHODS
A total of 51 patients participated in this trial (power = 36%, 2-tailed test).


METHODS
Patients presenting with traumatic hyphema were randomly assigned to 5-day treatment with topical aminocaproic acid or a placebo gel. Patients were monitored daily with ocular examination and vital sign testing for the 5 days of treatment and at 24 and 48 hours after treatment. General physical examination and laboratory testing were performed at baseline and day 5.


METHODS
The main efficacy variable was the rate of rebleeding. Secondary efficacy variables included time to hyphema clearance, intraocular pressure, time to secondary hemorrhage, and visual acuity. Safety variables included adverse events, vital signs, and laboratory measurements.


RESULTS
Rebleeding occurred in 30% of the placebo group (8 of 27; 95% confidence interval [CI] = 14-50%), versus 8% of the treatment group (2 of 24; 95% CI = 1-27%), for an estimated continuity-corrected difference in percentage of patients with bleeding of 17% (95% CI = -3-38%). Secondary efficacy variables were similar in the groups, except that there was a trend towards more visual improvement in the topical aminocaproic acid group (54%) than in the placebo group (30%) at the last measurement (P = 0.08). Adverse events were similar.


CONCLUSIONS
This study provides evidence that topical aminocaproic acid is safe and demonstrates trends towards reducing the rebleeding rate in the management of traumatic hyphema. However, because the study was terminated before complete enrollment, more definitive recommendations will require a larger trial.
Pieramici
Dante J
DJ
Wilmer Ophthalmological Institute, Baltimore, Maryland, USA.
Goldberg
Morton F
MF
Melia
Michele
M
Fekrat
Sharon
S
Bradford
Cynthia A
CA
Faulkner
Alan
A
Juzych
Mark
M
Parker
John S
JS
McLeod
Stephen D
SD
Rosen
Richard
R
Santander
Samuel H
SH
D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000368:Aged; D015119:Aminocaproic Acid / Q000009:adverse effects / Q000627:therapeutic use*; D000867:Anterior Chamber / Q000293:injuries*; D000933:Antifibrinolytic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005131:Eye Injuries / Q000150:complications / Q000188:drug therapy*; D005260:Female; D005782:Gels; D006801:Humans; D006988:Hyphema / Q000188:drug therapy* / Q000209:etiology; D007429:Intraocular Pressure; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions; D012008:Recurrence; D012449:Safety; D016896:Treatment Outcome; D014792:Visual Acuity
D000933:Antifibrinolytic Agents; D005782:Gels; D009883:Ophthalmic Solutions; D015119:Aminocaproic Acid