Original article
The comparison of efficacies of topical corticosteroids and nonsteroidal anti-inflammatory drops on dry eye patients: a clinical and immunocytochemical study

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Abstract

Purpose

To investigate whether conjunctival inflammation represents a primary event in the pathogenesis of keratoconjunctivitis sicca or whether it is a secondary inflammatory reaction caused by enhanced mechanical irritation as a result of surface dryness and whether anti-inflammatory drops (corticosteroids and nonsteroidal anti-inflammatory) have therapeutic effects and are similar.

Design

Single-masked, randomized, prospective clinical trial.

Methods

Thirty-two keratoconjuctivitis patients with or without Sjögren syndrome were included in the study. The patients were randomized to three groups. Group 1 patients received a topical artificial tear substitute (ATS); group 2 received ATS plus nonsteroidal anti-inflammatory drops (NSAID); and group 3 received ATS plus topical corticosteroidal drops. The eye symptom severity scores, Schirmer test values, rose bengal and fluorescein staining scores were evaluated before treatment and 15 and 30 days after start of treatment. Impression cytology specimens were stained using immunohistochemical methods to detect the percentages of human leukocyte antigen II (HLA-DR) positive, Apo 2.7 positive, and periodic acid–Schiff positive cells. Statistical analyses were performed within and between groups.

Results

Group 3 patients had significantly lower symptom severity scores, fluorescein and rose bengal staining, and HLA-DR positive cells on days 15 and 30 compared with patients in other groups. They also had a significantly higher number of periodic acid–Schiff positive (goblet) cells in their impression cytology specimens on days 15 and 30 compared with the other patients. On day 30, group 3 patients had significant differences compared with their baseline measurements in terms of above-mentioned parameters. However, we did not detect a significant effect of any treatment schedule on the Shirmer test value and the numbers of Apo 2.7 cells in impression cytology specimens.

Conclusions

Topical corticosteroids had a clearly beneficial effect both on the subjective and objective clinical parameters of moderate-to-severe dry eye patients. These effects were associated with the reduction of inflammation markers of conjunctival epithelial cells.

Section snippets

Methods

The study was commenced as a single-site, prospective, randomized, and single-masked clinical trial. Informed consent was obtained from all patients, and the research was begun after obtaining approval from the Institutional Review Board of the Louisiana State University Health Sciences Center. The research was carried out according to the tenets of the Declaration of Helsinki. All study medications were dispensed in coded bottles. The examiner (A.M.A.) was masked as to the medication used by

Results

A total of 32 patients were enrolled in the study. Four patients were discontinued for administrative reasons. Eight patients in group 1, nine patients in group 2, and 11 patients in group 3 concluded the whole study period. None of the above discontinued patients reported adverse effects that could be related to the medications used in this study.

Group 1 contained five female and three male patients (mean age, 51.2 ± 12.4 SD). Five female and four male patients constituted group 2 (mean age,

Discussion

The most important results of this study were that treatment with TSD significantly improved the ocular signs and symptoms of moderate-to-severe dry eye patients, and these improvements were associated with reduction of HLA-DR+ cells and an increase of PAS+ cells in conjunctival impression cytology specimens. However, ATS alone or ATS plus NSAID did not change these parameters. Keratoconjunctivitis sicca is an autoimmune disease that involves not only the lacrimal gland but also the whole

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    InternetAdvance publication at ajo.com April 24, 2003.

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