Comparison of the effects of ketotifen fumarate 0.025% and olopatadine HCl 0.1 % ophthalmic solutions in seasonal allergic conjunctivitis: A 30-day, randomized, double-masked, artificial tear substitute-controlled trial

被引:46
作者
Avunduk, AM [1 ]
Tekelioglu, Y
Turk, A
Akyol, N
机构
[1] KTU Lojmanlari, Sch Med, Dept Ophthalmol, TR-61080 Trabzon, Turkey
[2] Karadeniz Tech Univ, Dept Histol & Embryol, Sch Med, TR-61080 Trabzon, Turkey
关键词
seasonal allergic conjunctivitis; ketotifen; olopatadine; flow cytometry; ICAM; VCAM; HLA-DR; CD29;
D O I
10.1016/j.clinthera.2005.09.013
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Background: Topical antiallergic agents, such as antihistamines and mast-cell stabilizers, are the main therapeutic options for seasonal allergic conjunctivitis (SAC). Ketotifen fumarate and olopatadine HCl have dual action that offers a combination of these 2 mechanisms. Although clinical studies comparing the efficacy of these 2 drugs have shown that both were effective in the treatment of SAC, the results were contradictory and did not include the effects of these drugs on inflammatory markers. Objectives: The alms of this study were to compare the clinical efficacy of topical ketotifen and olopatadine eye drops and to determine the effects of these 2 drugs on the expression of cell adhesion molecules (CAMs) and inflammatory markers in conjunctival surface cells in patients with SAC. Methods: This 30-day, randomized, double-masked, artificial tear substitute (ATS)-controlled clinical trial was conducted at the Department of Ophthalmology, Karadeniz Technical University, School of Medicine, Trabzon, Turkey. Patients with SAC were included in the study and randomly assigned to 1 of 3 groups: topical ketotifen fumarate 0.025% ophthalmic solution, topical olopatadine HCl 0.1% ophthalmic solution, or ATS (control group). All drugs were administered 2 drops per eye BID for 30 days. At the beginning of the study (day 0; baseline), on day 15, and on day 30, clinical scores (itching, tearing, redness, eyelid, swelling, and chemosis) and conjunctival impression cytology specimens were obtained. The percentages of cells expressing intercellular adhesion molecule 1, vascular CAM-1, human leukocyte antigen-DR, and beta(1)-integrin (CD29) from conjunctival impression cytology specimens were determined using flow cytometry. Patients were questioned about adverse events (AEs) at each visit. Ocular discomfort on installation of the drugs was recorded as an AE. Results: Thirty-nine patients (20 men, 19 women; age range, 18-61 years) with SAC were included. Twelve patients received ketotifen; 13, olopatadine; and 14, ATS. In both active-treatment groups, the improvements of clinical scores (tearing and itching) were more pronounced compared with those in the ATS group, although the day-30 difference in tearing score between the olopatadine and ATS groups was not statistically significant. No significant within-group or between-group differences in mean scores for redness, chemosis, or eyelid swelling were found. The expression rates of CAMs and inflammatory markers in conjunctival surface cells were significantly more reduced with ketotifen and olopatadine compared with ATS. However, clinical and flow cytometric parameters were improved with ATS at 15 and 30 days compared with baseline. No AEs were observed during the study period. Conclusions: In this short-term study in a selected, small study population with SAC, ketotifen and olopatadine diminished the expression of CAMs and inflammatory markers on the conjunctival surface cells effectively. Both active treatments were more efficacious compared with ATS and were well tolerated.
引用
收藏
页码:1392 / 1402
页数:11
相关论文
共 27 条
[1]   Evaluation of olopatadine, a new ophthalmic antiallergic agent with dual activity, using the conjunctival allergen challenge model [J].
Abelson, MB .
ANNALS OF ALLERGY ASTHMA & IMMUNOLOGY, 1998, 81 (03) :211-218
[2]   Clinical efficacy of olopatadine hydrochloride ophthalmic solution 0.2% compared with placebo in patients with allergic conjunctivitis or rhinoconjunctivitis: A randomized, double-masked environmental study [J].
Abelson, MB ;
Gomes, PJ ;
Vogelson, CT ;
Pasquine, TA ;
Gross, RD ;
Turner, FD ;
Wells, DT ;
Bergamini, MVW ;
Robertson, SM .
CLINICAL THERAPEUTICS, 2004, 26 (08) :1237-1248
[3]  
ABELSON MB, 1993, ANN ALLERGY, V70, P95
[4]   Combined analysis of two studies using the conjunctival allergen challenge model to evaluate olopatadine hydrochloride, a new ophthalmic antiallergic agent with dual activity [J].
Abelson, MB ;
Spitalny, L .
AMERICAN JOURNAL OF OPHTHALMOLOGY, 1998, 125 (06) :797-804
[5]   Comparative study of clinical efficacy and tolerance in seasonal allergic conjunctivitis management with 0.1% olopatadine hydrochloride versus 0.05% ketotifen fumarate [J].
Aguilar, AJ .
ACTA OPHTHALMOLOGICA SCANDINAVICA, 2000, 78 :52-55
[6]   OCULAR ALLERGY [J].
ALLANSMITH, MR ;
ROSS, RN .
CLINICAL ALLERGY, 1988, 18 (01) :1-13
[7]  
[Anonymous], DECL HELS
[8]   Flow cytometry tear analysis in patients with chronic allergic conjunctivitis [J].
Avunduk, AM ;
Avunduk, MC ;
Dayioglu, YS ;
Centinkaya, K .
JAPANESE JOURNAL OF OPHTHALMOLOGY, 1997, 41 (02) :67-70
[9]   A flow cytometric study about the immunopathology of vernal keratoconjuctivitis [J].
Avunduk, AM ;
Avunduk, MC ;
Dayanir, V ;
Tekelioglu, Y ;
Dayioglu, YS .
JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY, 1998, 101 (06) :821-824
[10]  
Bacon AS, 1998, INVEST OPHTH VIS SCI, V39, P322