Alomide®
lodoxamide 0.1% · ophthalmic solution
Allergy
Approved uses
Vernal keratoconjunctivitis, including vernal conjunctivitis and vernal keratitis
1 or 2 drops in each affected eye QID for up to 3 months
Effect builds over weeks of continuous QID dosing rather than after a single drop.
OFF-LABELNot in the FDA label for this product
Superior limbic keratoconjunctivitis
1 drop BID long term; the series added fluorometholone acetate 0.1% for 7 to 14 days at presentation and at relapse for moderate or severe inflammation
Uncontrolled series · n=34
Prospective, non-comparative series of 67 eyes in 34 patients on a mean 15.3 months of therapy: 82.0% of eyes reached control of inflammation at a mean of 2.2 months, signs improved significantly by month 3 (p<0.05), 35.8% reached remission, 18.0% relapsed on therapy, and 7.4% failed. No control arm and concomitant pulsed steroid, so the effect cannot be attributed to lodoxamide alone; it supports it as a steroid-sparing maintenance option, not as proven monotherapy.
Seasonal and perennial allergic conjunctivitis
1 drop in each eye QID; the trial ran 14 days
RCT · n=93 · no placebo arm
Randomized, double-masked, seven-center trial in 93 patients with seasonal or perennial allergic conjunctivitis, QID against levocabastine 0.05% BID: both arms produced statistically and clinically significant reductions from baseline in symptom and sign scores by days 7 and 14 with no difference between groups. After the first instillation, however, signs were relieved faster in the levocabastine arm (p<0.001), which is the practical argument for reaching for an antihistamine when a patient needs same-day relief. No placebo arm.
Contraindications
Hypersensitivity to any component of the product.
Ophthalmic solution, 0.1% (1.78 mg/mL lodoxamide tromethamine, equivalent to 1 mg/mL base), 10 mL plastic ophthalmic dispenser
Mast cell stabilizer: reported to prevent antigen-stimulated calcium influx into mast cells, blocking release of histamine and the peptidoleukotrienes, and it inhibits eosinophil chemotaxis and the in vivo Type I immediate hypersensitivity reaction. No intrinsic vasoconstrictor, antihistaminic, cyclooxygenase-inhibiting, or other anti-inflammatory activity, so it prevents mediator release rather than reversing a reaction already under way.
Warnings & Precautions
- Topical ophthalmic use only: Not for injection.
- Soft contact lenses: Should not be worn during treatment; preserved with benzalkonium chloride 0.007%.
- Transient burning or stinging: Expected on instillation; symptoms that persist warrant reevaluation.
- Tip contamination: Keep the dropper tip off any surface.
Common Side Effects
- Ocular: Transient burning, stinging, or discomfort on instillation in about 15%; itching, blurred vision, dry eye, tearing or discharge, hyperemia, crystalline deposits, and foreign body sensation in 1% to 5%.
- Uncommon ocular findings: Corneal erosion or ulcer, keratopathy or keratitis, corneal abrasion, epitheliopathy, and anterior chamber cells, each under 1%.
- Systemic: Headache in 1.5%; heat sensation, dizziness, somnolence, nausea, stomach discomfort, sneezing, dry nose, and rash each under 1%.
Pregnancy: No adequate and well-controlled studies in pregnant women; oral doses in rats and rabbits more than 5000 times the proposed human clinical dose produced no developmental toxicity. Use only if clearly needed.
Lactation: Excretion in human milk is unknown; use caution in nursing women.
Labeled from age 2; safety and effectiveness below age 2 not established.