Itch relief begins within 3 minutes and lasts at least 16 hours.
OFF-LABELNot in the FDA label for this product
Active mild to moderate allergic conjunctivitis, treatment rather than prevention
1 drop QD x 14 days
RCT · n=180 · single-site
Randomized observer-masked single-center trial (N=180, 60 per arm): mean total ocular symptom score fell from 7.7 at baseline to 0.2 at day 14 with alcaftadine, versus 0.4 with olopatadine 0.2% and 0.1 with bepotastine 1.5% (day 14 ANOVA P=0.0008); absolute separation between the three actives was small. Contact lens wearers and severe allergic conjunctivitis were excluded.
Ophthalmic solution, 3 mL fill in 5 mL bottle, 0.25% (2.5 mg/mL)
Mechanism of Action
H1 histamine receptor antagonist and inhibitor of histamine release from mast cells. Decreased chemotaxis and inhibition of eosinophil activation have also been demonstrated.
Warnings & Precautions
Contact lens wear: Lenses out before instillation and not in place at dosing; the benzalkonium chloride preservative is absorbed by soft lenses. Reinsertion permitted 10 minutes after dosing.
Contact lens-related irritation: Not indicated for it, and lenses should not be worn on a red eye.
Eye injury and tip contamination: Dropper tip contact with the eyelids, surrounding areas, or any other surface risks ocular injury and contamination of the solution.
Common Side Effects
Ocular: Eye irritation, burning or stinging on instillation, eye redness, eye pruritus; under 4% of treated eyes.
Systemic: Nasopharyngitis, headache; under 3% of subjects.
Postmarketing: Eye discharge, eye swelling, eyelid edema and erythema, increased lacrimation, blurred vision, hypersensitivity reactions including facial swelling or allergic dermatitis, somnolence.
Pregnancy & Lactation
Pregnancy: No adequate and well-controlled studies in pregnant women and limited human data. Oral dosing through organogenesis in rats and rabbits produced no maternal or embryofetal toxicity at clinically relevant doses; use only if the potential benefit justifies the potential risk to fetus and mother.
Lactation: No information on presence in human milk, effects on the breastfed infant, or effects on milk production.
Pediatric Use
Safety and effectiveness below age 2 not established.
Available Forms
Mechanism of Action
Pregnancy & Lactation
Pediatric Use