Double-masked, randomized, parallel-group study comparing olopatadine 0.1% ophthalmic solution with cromolyn sodium 2% and levocabastine 0.05% ophthalmic preparations in children with seasonal allergic conjunctivitis

Abstract

Background: It is estimated that >50% of medications have not been tested in children. Physicians need pediatric data to guide them in treating children. Olopatadine hydrochloride ophthalmic solution 0.1% is a topical antiallergic agent that is both an antihistamine with high affinity and selectivity for the histamine H 1 receptor and a mast cell stabilizer that inhibits the release of histamine and other proinflammatory mediators from human conjunctival mast cells. The efficacy and tolerability of olopatadine has been demonstrated by comparative studies in adults and children with seasonal allergic conjunctivitis (SAC).Objective: Pediatric patient data were extracted from 2 clinical trials to assess the efficacy and tolerability of olopatadine hydrochloride ophthalmic solution 0.1% compared with those of cromolyn sodium ophthalmic solution 2% and levocabastine ophthalmic solution 0.05% as treatment for SAC in children.Methods: In study 1, conducted at 15 centers in 7 countries (Europe and Australia) from October 1995 to December 1997, olopatadine was instilled BID and placebo (vehicle) BID for 6 weeks and compared with cromolyn instilled QID. Study 2, conducted at 17 centers in 8 countries (Europe and Australia) from November 1998 to June 2000, compared olopatadine BID with levocabastine BID. In both studies, children of either sex and any race, aged 4 to 11 years, and having proven grass pollen allergies were assigned to treatment in a double-masked, randomized fashion. Slit-lamp examination, the physician's imAccepted for publication February 22, 2004. Reproduction in whole or part is not permitted.0011-393X/04/$19.00 pression scale, and self-ratings were used to obtain efficacy data. Data analyses were based on pollen concentrations. The tolerability assessments were based on visual acuity, pupil diameter, intraocular pressure, and a dilated fundus examination. C U R R E N T T H E R A P E U T I C R E S E A R C H ாVResults: Study 1 comprised 30 children (olopatadine [n = 13] and cromolyn sodium [n = 17]; 18 boys, 12 girls; mean age, 7.9 years [range, 4-11 years]). Study 2 comprised 22 children (olopatadine [n = 10] and levocabastine [n = 12]; 12 boys, 10 girls; mean age, 8.6 years [range, 5-11 years]). In study 1, ocular itching (P = 0.010), redness seen on slit-lamp examination (P = 0.003), and eyelid swelling (P = 0.034) were significantly less intense with olopatadine than with cromolyn sodium during the peak pollen period. In study 2, redness seen on slit-lamp examination (P = 0.040) and self-rated ocular redness (P = 0.024) were significantly less intense with olopatadine than levocabastine during the peak pollen period. Olopatadine was well tolerated.Conclusion: Olopatadine hydrochloride ophthalmic solution 0.1% was more effective than both cromolyn sodium 2% and levocabastine 0.05% ophthalmic preparations in controlling ocular signs and symptoms of SAC in children and was well tolerated when administered twice daily for 6 weeks. (Curr Ther Res Clin Exp.

Clinical implications of mast cell involvement in allergic conjunctivitis

“…Olopatadine has demonstrated capable inhibition of various cytokines including TNF‐α . It is active in the conjunctival allergen challenge model and has a rapid onset of action (within 20 min after instillation) and a duration of ≥8 h . Topical multiple action agents appear to inhibit the effects of histamine as well as the synthesis of additional inflammatory mediators that accentuate the late‐phase response of the anterior surface of the eye …”

Assessment of the efficacy of olopatadine 0.1% in the treatment of vernal keratoconjunctivitis in terms of clinical improvement based on total ocular symptom score and ocular surface disease index

“…[ 14 , 15 ] Olopatadine, a dual-action agent, with antihistamine property selectively blocks histamine H1 receptors and prevents vasoconstriction in the initial phase of VKC while the mast cell stabilizing effects prevent the degranulation of mast cells in the later stages, thereby controlling the allergic reaction. The rapid onset of action, shorter treatment period, long-lasting effectiveness, effective in reducing both early and late phases of allergic inflammation, easy availability, and low cost of drug[ 16 , 17 ] have widely increased the administration of olopatadine in the treatment of allergic conjunctivitis including VKC. [ 9 ]…”