Efficacy of olopatadine HCI 0.1%, ketotifen fumarate 0.025%, epinastine HCI 0.05%, emedastine 0.05% and fluorometholone acetate 0.1% ophthalmic solutions for seasonal allergic conjunctivitis: a placebo-controlled environmental trial

Acta Ophthalmol. 2009 Aug;87(5):549-54. doi: 10.1111/j.1755-3768.2008.01265.x. Epub 2008 Jul 9.


Purpose: We aimed to compare the clinical efficacy and ocular surface variables of olopatadine, ketotifen fumarate, epinastine, emedastine and fluorometholone acetate ophthalmic solutions in preventing the signs and symptoms of seasonal allergic conjunctivitis (SAC).

Methods: This was a prospective, randomized, double-blinded and placebo-controlled study. A total of 100 patients with SAC were randomly assigned to one of five groups, in which they were administered olopatadine, ketotifen fumarate, epinastine, emedastine or fluorometholone acetate, instilled twice daily for 2 weeks. One eye of each patient was treated with the study drug and the other was treated with a placebo. Signs and symptoms of allergic conjunctivitis (itching, redness, tearing, chemosis and eyelid swelling) were scored on a 4-point scale. Each symptom was assessed at baseline and then again after 1 and 2 weeks of treatment. Ocular surface variables were assessed by conjunctival impression cytology.

Results: At weeks 1 and 2, all antiallergic agents were significantly more effective than placebo in alleviating itching, redness, tearing, chemosis and eyelid swelling. Fluorometholone acetate was significantly less effective than the other agents in reducing itching and redness at all control visits. Ocular surface findings by impression cytology improved significantly after all treatments compared with placebo.

Conclusions: In patients with SAC, olopatadine, ketotifen, epinastine and emedastine are more efficacious than fluorometholone acetate in preventing itching and redness. All the antiallergic agents gave similar results in terms of reducing tearing, chemosis and eyelid swelling. Our data showed that impression cytology parameters improved after treatment with antiallergic agents in patients with SAC.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Anti-Allergic Agents / administration & dosage*
  • Benzimidazoles / administration & dosage
  • Child
  • Conjunctival Diseases / drug therapy
  • Conjunctivitis, Allergic / drug therapy*
  • Conjunctivitis, Allergic / physiopathology
  • Dibenzazepines / administration & dosage
  • Dibenzoxepins / administration & dosage
  • Double-Blind Method
  • Edema / drug therapy
  • Eyelid Diseases / drug therapy
  • Female
  • Fluorometholone / administration & dosage
  • Histamine H1 Antagonists / administration & dosage*
  • Humans
  • Imidazoles / administration & dosage
  • Ketotifen / administration & dosage
  • Male
  • Middle Aged
  • Olopatadine Hydrochloride
  • Ophthalmic Solutions
  • Prospective Studies
  • Pruritus / prevention & control
  • Seasons*
  • Tears / drug effects
  • Tears / metabolism
  • Treatment Outcome
  • Young Adult


  • Anti-Allergic Agents
  • Benzimidazoles
  • Dibenzazepines
  • Dibenzoxepins
  • Histamine H1 Antagonists
  • Imidazoles
  • Ophthalmic Solutions
  • Olopatadine Hydrochloride
  • emedastine
  • epinastine
  • Fluorometholone
  • Ketotifen