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A double-blind evaluation of topical levocabastine, a new specific H1 antagonist in patients with allergic conjunctivitis.

Forty patients suffering from allergic conjunctivitis, due to birch pollen, participated in a double-blind parallel group comparison between levocabastine (a potent new specific histamine (H1) antagonist) and placebo, both given as eye drops. Symptom scores were recorded during a 4-week period. A 1-week run-in period was followed by a 3-week treatment period. To enable a fair evaluation of the treatment effect on the ocular symptoms only, all patients were treated with topical nasal glucocorticoids for possible rhinitis symptoms during the whole study period. Plasma levels of levocabastine were determined in all subjects at the end of the 3 weeks' treatment period. Pollen counts for birch pollen were followed simultaneously. The evaluation of the symptom score cards revealed a significant reduction of ocular symptoms following use of the active compound. The resorption of the active substance through the conjunctiva was low. In accordance with the present trend of more topical treatment for allergic rhinitis, levocabastine may constitute a valuable compound for the topical treatment of allergic conjunctivitis.

Adolescent↗

Topical levocabastine versus sodium cromoglycate in allergic conjunctivitis.

The aim of this study was to evaluate the effect of levocabastine, a new H1-blocking antihistamine for topical use, in comparison with sodium cromoglycate on conjunctival symptoms of birch pollinosis. The two drugs were compared in a randomized double-blind comparative study over 5 weeks in 37 children and adolescents (6-19 years of age) with birch pollen conjunctivitis. Nasal symptoms occurred in 31 of the children and were treated with beclomethasone dipropionate nasal spray. An oral antihistamine was offered as rescue medication for eye symptoms. Initially, the patients received placebo four times a day for a 7-day run-in period. Conjunctival symptoms were recorded daily on diary cards on a 100 mm visual analogue scale. The pollen counts indicated a short but intensive birch pollen season. There was no statistically significant difference between the two treatment groups with regard to eye symptom scores before and during active treatment. However, the patients' evaluation of the efficacy of the therapy was in favour of levocabastine (P less than 0.01). Topical levocabastine, an H1-blocker, applied twice daily, seems to protect from symptoms of allergic conjunctivities as favourably as sodium cromoglycate applied four times a day. There was no difference in number or character of reported adverse reactions between the two treatment groups.

Adolescent↗

Non-steroidal treatment of pollen-induced conjunctivitis: comparison of different pharmacological protocols.

Pharmacological treatment of allergic conjunctivitis may be based on the therapeutic use of topical steroids; however, because of the side effects, steroids are not clinically suitable in either prolonged treatment, or pollinosis. Because non-steroidal topical drugs are suitable in prolonged treatment, this single-blind study evaluated the following topical drugs: cromoglycate plus chlorphenamine, cromoglycate plus tetryzolin and imidazolin plus nafazolin, compared with placebo. The results confirm significant clinical efficacy of these drugs on signs and symptoms compared with placebo. Thus, "non-steroidal" topical drugs should be the preferred choice in prolonged forms of pollen-induced (e.g. Parietaria and/or grasses) conjunctivitis.

Administration, Topical↗

Topical levocabastine is more effective than sodium cromoglycate for the prophylaxis and treatment of seasonal allergic conjunctivitis.

The efficacy, tolerability, and adverse-effect profile of the recently developed, topical antihistamine levocabastine were compared with those of sodium cromoglycate in a 4-week double-blind, placebo-controlled trial in 95 patients with seasonal allergic conjunctivitis. At the end of the trial, global therapeutic efficacy was considered to be excellent or good in 87% of levocabastine-treated patients, as compared with 68% of sodium cromoglycate-treated patients (P = 0.006) and 63% of those who received placebo (P = 0.05). After 4 weeks of treatment, levocabastine patients had experienced significantly greater relief from their most severe ocular symptom than patients in the sodium cromoglycate group (P < 0.05). Furthermore, 37% of levocabastine-treated patients were virtually symptom-free for at least 75% of the treatment period, as compared with only 6% of patients in the sodium cromoglycate group (P < 0.01) and 4% of those who received placebo (P < 0.01). Moreover, this trend was maintained on days when the pollen count was high, when the corresponding figures were 33%, 6% (P = 0.02), and 4% (P = 0.02), respectively. Levocabastine was well tolerated. Indeed, the incidence of adverse reactions was no greater in the levocabastine group than in the placebo group. Topical levocabastine is an effective and well-tolerated drug for the prophylaxis and treatment of seasonal allergic conjunctivitis.

Administration, Topical↗

A double-blind group comparative study of ophthalmic sodium cromoglycate, 2% four times daily and 4% twice daily, in the treatment of seasonal allergic conjunctivitis.

In a multicenter, double-blind, single-dummy, group-comparative study, 169 patients received ophthalmic sodium cromoglycate 2% four times daily, and 170 patients received 4% ophthalmic sodium cromoglycate twice daily, together with placebo eye-drops twice daily, for the treatment of seasonal allergic conjunctivitis (SAC) to birch pollen. The treatment period was 4 weeks during the birch pollen season. Daily pollen counts were used to identify the peak 14-d period. Clinical examinations were made before the start of treatment, after 1 week of treatment, and at the end of the treatment period. Patients kept daily diary record cards of eye symptom severity and concomitant therapy. Symptoms were generally mild and, except for chemosis (week 4) and soreness (weeks 2 and 3), which were less in the 4% group (P < or = 0.05), no significant treatment differences were seen for symptoms or for antihistamine rescue therapy. Both treatments were considered to be very or moderately effective by more than 90% of patients, and no treatment differences occurred in either clinicians' or patients' opinions of efficacy. The results indicate that the use of 4% sodium cromoglycate eye-drops twice daily is as effective and well tolerated as 2% sodium cromoglycate four times daily in the treatment of birch-pollen conjunctivitis.

Adolescent↗

Efficacy of mequitazine in comparison with placebo assessed by ocular challenge with allergen in allergic conjunctivitis.

Pharmacologic intervention in the management of allergic conjunctivitis was evaluated with different topical ocular agents in man. Their effect can be precisely assessed with the conjunctival provocation test (CPT). A potent specific H1-receptor antagonist, 0.05% mequitazine eye-drops, was tested in a double-blind randomized, placebo-controlled study using CPT with grass pollen allergens. Twenty healthy subjects allergic to grass pollen were included outside the pollen season after a positive CPT screening. They received one drop of 0.05% mequitazine in one eye and the vehicle in the contralateral eye in a random order, four times daily for 5 days. CPT was performed 15 min after the last instillation, and the threshold dose inducing a positive reaction was determined. Results were given by Abelson's composite score including redness, chemosis, tearing, and itching. Topical 0.05% mequitazine significantly reduced the composite score compared to placebo. The allergen threshold concentration which induced the positive conjunctival reaction was higher in mequitazine pretreated eyes. No side-effect was reported. These data clearly suggest that mequitazine has potential to treat allergic conjunctivitis.

Adult↗

Azelastine eye-drops in seasonal allergic conjunctivitis or rhinoconjunctivitis. A double-blind, randomized, placebo-controlled study.

This study was carried out to assess the efficacy of 0.025% and 0.05% azelastine eye-drops in patients with seasonal allergic conjunctivitis of > or = 1 year's duration. A total of 151 patients received 0.025% or 0.05% azelastine eye-drops or placebo b.i.d. for 14 days according to a double-blind, randomized, placebo-controlled, parallel-dosing design; 129 patients completed the study as planned. The three target symptoms, scored on 4-point scales, were itching, lacrimation, and redness of the eyes; responders were patients whose symptom sum score decreased by > or = 3 from a baseline score of > or = 6 by day 3. Mean scores of these and five other symptoms were recorded also on days 7 and 14, and patients kept daily diaries of the three main symptoms and swollen eyelids. Responder rates were 73% for 0.025% (P=0.115 vs placebo) and 82% for 0.05% azelastine eye-drops (P=0.011 vs placebo) and 56% for placebo. The time courses of the mean (investigators' and patients') scores for the three main symptoms reflected the dose-dependent effect of azelastine eye-drops. One patient each from the two azelastine groups and three from the placebo group withdrew because of inefficacy. Adverse drug reactions were reported by 14 and 24 patients receiving 0.025% and 0.05% azelastine eye-drops, respectively, and by eight placebo patients. These reactions were mainly slight application site reactions and taste perversion (bitter or unpleasant taste). Azelastine eye-drops are effective and well tolerated at a dose of 0.05% for the treatment of seasonal allergic conjunctivitis.

Adolescent↗

Bilateral chronic conjunctivitis and corneal scarring in a boy with X-linked hypogammaglobulinaemia.

We report an unusual case of bilateral chronic conjunctivitis and corneal scarring in a boy with X-linked hypogammaglobulinaemia (XLH) who did not respond to the usual antibacterial and antiviral therapy. An immunofluorescence test for Chlamydia trachomatis from an eye swab was strongly positive. Within days of commencement of local and systemic tetracycline therapy, he showed marked improvement. Since conjunctival follicle formation, which depends on the presence of a B-cell population, may not occur in XLH, clinical examination in chlamydia conjunctivitis may be misleading and lead to a delay in diagnosis and treatment with resulting corneal complications, unless laboratory evidence of chlamydia infection is specifically sought.

Agammaglobulinemia↗

Granulomatous conjunctivitis in an ostrich.

Ostriches lack meibom glands, but have small lacrimal glands ventral to the lateral canthus, with ductules that open into the inside of the lower eyelid. Chalazion is a chronic granulomatous inflammation of the meibom glands that may develop from blockage of the ductules into the conjunctiva. A 2-year-old female ostrich presented with chronic granulomatous conjunctivitis, with clinical and histopathologic findings similar to chalazion of other species. The granulomatous dacryoadenitic mass was excised and no recurrence occurred at 4 months. This is the first case of chronic granulomatous conjunctivitis reported in the ostrich.

Animals↗

Primary meningococcal conjunctivitis.

Neisseria meningitidis is an uncommon cause of acute bacterial conjunctivitis. One case of primary meningococcal conjunctivitis in a healthy 6-year-old boy is reported. The patient was initially treated with a topical instillation of polymyxin B, neomycin and gramicidin in ophthalmic solution, and this was followed by systemic rifampin once the diagnosis had been established. No ocular or systemic complications developed.

Administration, Oral↗

Unilateral refractory (erosive) conjunctivitis: a peculiar manifestation of pemphigus vulgaris.

A woman aged 57 years had conjunctivitis of the right eye since February 2003. It had started with a pinhead-sized blister at the margin of the upper eyelid and was progressive in nature. Intense redness of the right eye, lacrimation, and severe pain confined to the right forehead were the major complaints. She had been under medical care ever since, without any tangible outcome. Its refractory nature impelled the ophthalmologist to seek dermatologic consultation, for apparently the diagnosis seemed to have eluded the consultant. Accordingly, she reported on March 2, 2004 for the opinion of severe incessant itching, profuse lacrimation, and pain that was confined only to the right eye and forehead. The very fact that she had reported with continuous rubbing of the right eye re-enforced the suspicion of the episode being an exclusive expression of pemphigus vulgaris of the eye that probably was the reason for ineffectiveness of the drugs given thus far to her. Examination of the right eye was marked by intense inflammation of the palpebral and bulbar conjunctiva, apparent in the form of severe redness (Figure 1). The conjunctiva was studded with several scattered minute erosions. Corneal opacity and cataract were its accompaniment, whereas the left eye was normal. Mucous membrane of the oral cavity was thoroughly scanned for blister and/or erosions but was normal. The rest of the skin surface was also unaffected. Nikolsky's sign was elicited by asking the patient to rub the eye. In fact, this was responsible for periodic recurrence of the episode. Tzanck test was performed by preparing, fixing, and Giemsa staining the smear from one of the erosions over the conjunctiva. The stained slides were examined under oil-immersion, which revealed plentiful acantholytic cells characterized by large nucleus containing nucleoli and occupying almost the entire eosinophilic cytoplasm and basophilic cell wall. The two biopsies from the conjunctiva were also taken with the help of a 3-mm punch. One of the biopsies was subjected to serial sections. The sections were stained with hematoxylin and eosin stain and examined by light microscopy. The presence of split/cleavage in the epidermis (intraepidermal) above the basal (suprabasal) was cardinal. The cleavage was filled with acantholytic cells of characteristic morphology (vide supra) (Figure 2). The other biopsy was subjected to direct immunofluorescence and was found complementary to the preceding microscopic pathology. Routine investigations comprising total and differential leukocyte count, liver and kidney function tests, chest skiagram, and electrocardiogram were normal. The preceding findings were fairly conducive to form the diagnosis of erosive conjunctivitis emanating from pemphigus vulgaris. Accordingly, pulse therapy (intermittent high-dose) containing 100 mg dexamethasone in 5% glucose daily by slow IV infusion on 3 consecutive days, along with 500 mg of cyclophosphamide on Day 1 only followed by continuous low-dose 50 mg cyclophosphamide, was administered. The patient has since recovered completely and is now under surveillance.

Conjunctivitis↗

Topical lomefloxacin twice daily compared with fucidic acid in acute bacterial conjunctivitis.

Forty-five patients with presumed acute bacterial conjunctivitis were treated in an investigator-masked randomized multicenter study with either lomefloxacin 0.3% or fucidic acid 1% eye drops twice daily. Clinical signs and symptoms were rated by slit-lamp examination and conjunctival swab cultures were performed to evaluate clinical and microbiological efficacy. A total of 57 ocular isolates were tested for susceptibility to nine antibiotics. A significant decrease in clinical symptomatology was achieved by both treatments with a gradual improvement over the treatment period of 7-9 days. Bacteriological recovery was frequently achieved already at the first control visit (day 3-5), but the recovery rate was statistically significant (p = 0.014) only in the lomefloxacin group. The relatively high in vitro resistance rate (46%) to fucidic acid was not reflected by lower clinical efficacy. Two unrelated adverse events (one in each treatment group) and minimal local intolerance problems were observed in both treatment groups. A significantly higher incidence of burning sensation was observed with fucidic acid than with lomefloxacin (p < 0.01). All four treatment failures in the study occurred in the fucidic acid group. Lomefloxacin 0.3% ophthalmic solution demonstrated a high efficacy and good tolerance in the management of acute bacterial conjunctivitis.

Acute Disease↗

Isolation of Chlamydia psittaci from cats with conjunctivitis.

Chlamydia psittaci was repeatedly demonstrated in stained smears of conjunctival scrapings from a group of cats in a single household and in 5 instances the organism was isolated by yolk sac inoculation of 6-day-old pathogen free, embryonated hen eggs. Thirteen of 15 cats in the cattery developed conjunctivitis at various times over a 9-month period. The outstanding features of the disease were its severity, chronicity and refractoriness to treatment. Prolonged (2 week) treatment with tetracycline was required to effect clinical recovery. Nine of 14 cats in the household developed significant complement-fixing (CF) antibody titres (greater than 128) to the chlamydia group antigen. A single serum from the owner had a titre of 32 although no associated illness was recognized. Of 134 serums collected from random source cats aged 1 month to 16 years, 17 (12.7%) also contained CF antibody to chlamydia group antigen. This is the first report of the isolation of chlamydia from cats with conjunctivitis outside North America and the first report to indicate general incidence figures for chlamydia infection of cats where vaccination is not used.

Animals↗

May Trichomonas vaginalis provoke conjunctivitis?

In the world literature we have found descriptions of five cases of Trichomonas vaginalis in the conjunctiva. Conjunctival swabs taken from 122 patients with conjunctivitis or keratitis revealed no flagellate micro-organisms on phase-contrast microscopy and culture. Neither did conjunctival swabs from 272 newborn infants, in spite of the fact that 3.7 per cent of their mothers had Trichomonas in the vagina. Trichomonas vaginalis is hardly likely to be responsible for conjunctivitis.

Adolescent↗

Giant papillary conjunctivitis in connection with corneoscleral supramid (nylon) suture knots.

A material consisting of 27 patients had corneoscleral wound closure by 8-0 polyamide (supramid, nylon) sutures after intracapsular cataract extraction and intraocular lens implantation. A few months after surgery 16 patients had developed giant papillary conjunctivitis of the upper tarsus of the operated eye, associated with itching and blurring. The earlier stages of the condition, as described by other authors, could be defined in the remaining 11 patients. Cytologic tests - pipette samples of tear fluid and tarsal conjunctival scrapings - demonstrated eosinophil leucocytes and neutrophilia in most of the giant papillary conjunctivitis cases. The conjunctival scraping proved the more sensitive test for detection of eosinophils, the pipette test being mainly an indicator of inflammatory reaction. The condition seems to be allergic with an element of mechanical irritation. The use of polyamide sutures of the 8-0 size is not recommended.

Aged↗

Tear film flow and stability in acute and chronic conjunctivitis.

Tear film flow and stability studies were carried out in patients suffering from acute and chronic conjunctivitis by performing Schirmer test-I and break-up-time (BUT) measurements. In this clinical study, patients with chronic conjunctival inflammation demonstrated a premature break-up of tear film despite normal amounts of aqueous tears. In acute catarrhal conjunctivitis the values of BUT were within normal limits, whereas the values of Schirmer test-I were significantly higher (t-test, P less than 0.001) and are considered to be due to reflex hypersecretion of tears.

Adult↗

Pseudomembranous and membranous conjunctivitis. Immunohistochemical features.

A 63-year-old man, who had for one month been on sulfasalazine therapy, developed general malaise, high fever, severe stomatitis, and bilateral necrotizing pseudomembranous conjunctivitis with corneal erosion, identical to that seen in the Stevens-Johnson syndrome. Topical therapy with antibiotics and aprotinin rapidly healed the corneal surfaces, while densely adherent true membranes developed on the conjunctiva, and were removed surgically several times during the next week. After the acute stage, subtle subepithelial conjunctival scarring, superficial punctate keratitis, dry eye syndrome and fluctuating irregular corneal astigmatism became evident, but good visual acuity, lid function and ocular motility were retained. Histopathologic study of conjunctival membranes from two cases of membranous conjunctivitis revealed polymorphonuclear leukocytes within a matrix composed of fibrin, tenascin and fibronectin. In older membranes, histiocytes were additionally found. Surgical debridement of such membranes removes a substratum of inflammatory debris that is likely to promote secondary infection, fibrosis and symblepharon formation, and may decrease rather than increase subsequent scarring of the necrotized conjunctiva.

Adult↗

Nedocromil sodium and astemizole, alone or combined, in the treatment of seasonal allergic conjunctivitis. A multicentre double blind clinical trial.

Two hundred and seven patients with active symptoms of allergic conjunctivitis were studied in a four-week multicentre double blind, double dummy, clinical trial comparing efficacy and safety of nedocromil sodium eye drops with oral astemizole, placebo, and the combined active treatments. Clinical signs were evaluated by clinicians after 1, 2 and 4 weeks, while symptoms were recorded by patients on daily diary cards. Overall opinions were recorded at the end of treatment. Nedocromil sodium eye drops and astemizole, alone or combined, significantly reduced ocular symptoms when compared to placebo (diary card total symptom score and patients' opinion). In the clinicians' opinion nedocromil sodium alone or combined (but not astemizole alone) significantly decreased ocular symptoms when compared to placebo. All treatments were safe and well tolerated, drowsiness being the most frequent side effect observed in patients treated with astemizole. These results indicate the effectiveness of nedocromil sodium eye drops in the treatment of seasonal allergic conjunctivitis.

Adolescent↗