PMID- 16291412
OWN - NLM
STAT- MEDLINE
DCOM- 20061113
LR  - 20181203
IS  - 0149-2918 (Print)
IS  - 0149-2918 (Linking)
VI  - 27
IP  - 9
DP  - 2005 Sep
TI  - Comparison of the effects of ketotifen fumarate 0.025% and olopatadine HCl 0.1% 
      ophthalmic solutions in seasonal allergic conjunctivities: a 30-day, randomized, 
      double-masked, artificial tear substitute-controlled trial.
PG  - 1392-402
AB  - 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 aims 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 
      beta1-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.
FAU - Avunduk, Avni Murat
AU  - Avunduk AM
AD  - Department of Ophthalmology, Karadeniz Technical University, School of Medicine, 
      Trabzon, Turkey. avunduk@ttnet.net.tr
FAU - Tekelioglu, Yavuz
AU  - Tekelioglu Y
FAU - Turk, Adem
AU  - Turk A
FAU - Akyol, Nurettin
AU  - Akyol N
LA  - eng
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 0 (Anti-Allergic Agents)
RN  - 0 (Cell Adhesion Molecules)
RN  - 0 (Dibenzoxepins)
RN  - 0 (HLA-DR Antigens)
RN  - 0 (Integrin beta1)
RN  - 0 (Ophthalmic Solutions)
RN  - 2XG66W44KF (Olopatadine Hydrochloride)
RN  - X49220T18G (Ketotifen)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Anti-Allergic Agents/administration & dosage/*therapeutic use
MH  - Cell Adhesion Molecules/metabolism
MH  - Conjunctiva/*drug effects/immunology/metabolism
MH  - Conjunctivitis, Allergic/*drug therapy/metabolism/pathology
MH  - Dibenzoxepins/administration & dosage/*therapeutic use
MH  - Female
MH  - HLA-DR Antigens/metabolism
MH  - Humans
MH  - Integrin beta1/metabolism
MH  - Ketotifen/administration & dosage/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Olopatadine Hydrochloride
MH  - Ophthalmic Solutions
MH  - Pruritus/drug therapy
MH  - Seasons
MH  - Tears/drug effects/metabolism
MH  - Time Factors
EDAT- 2005/11/18 09:00
MHDA- 2006/11/14 09:00
CRDT- 2005/11/18 09:00
PHST- 2005/07/21 00:00 [accepted]
PHST- 2005/11/18 09:00 [pubmed]
PHST- 2006/11/14 09:00 [medline]
PHST- 2005/11/18 09:00 [entrez]
AID - S0149-2918(05)00178-5 [pii]
AID - 10.1016/j.clinthera.2005.09.013 [doi]
PST - ppublish
SO  - Clin Ther. 2005 Sep;27(9):1392-402. doi: 10.1016/j.clinthera.2005.09.013.