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To analyze the effect of azithromycin 1% ophthalmic solution in DuraSite (InSite Vision, Inc, Alameda, California, USA) on bacterial conjunctivitis.Prospective, randomized, vehicle-controlled, parallel-group, double-masked multicenter clinical study.Eligible male or female participants with a clinical diagnosis of acute bacterial conjunctivitis were randomized to either 1% azithromycin in DuraSite or vehicle for five days. Infected eyes were dosed twice daily on days 1 and 2 and once daily on days 3 through 5. Conjunctival cultures were obtained at baseline, visit 2 (day 3 or 4), and visit 3 (day 6 or 7). The primary end point was clinical resolution of signs and symptoms (rating of zero on ocular discharge, bulbar and palpebral injection) at visit 3. Efficacy measures were clinical resolution and bacterial eradication as evaluated in the per-protocol population. Safety was assessed by adverse events, slit-lamp findings, and ophthalmoscopy.Two hundred and seventy-nine participants (n = 130, 1% azithromycin in DuraSite; n = 149, vehicle), age one to 96 years, were evaluated for efficacy. Clinical resolution with azithromycin ophthalmic solution was statistically significant compared with that of vehicle (P = .030) at visit 3. Bacterial eradication rates with azithromycin ophthalmic solution reached 88.5% at visit 3 (P.001) and included some pathogens resistant to azithromycin in vitro. Overall, adverse event rates were similar in both treatment groups.Azithromycin 1% ophthalmic solution in DuraSite showed statistically significant differences in clinical resolution and bacterial eradication rates when compared with vehicle. Because it was well tolerated in this population, it may be a viable treatment option for children and adults with bacterial conjunctivitis.

To determine the duration of action of ketotifen 0.025% eye drops vs placebo taken as single or multiple doses in an allergen challenge model.Two randomized, multicenter, double-masked, contralateral placebo-controlled studies, one a single-dose and one a multiple-dose study.Two conjunctival provocation tests (CPTs) were initially conducted to confirm reproducibility of subject responses in both studies. Subjects in study 1 (n = 87) received single doses of ketotifen in one eye and placebo in the other 15 minutes, 6 hours, and 8 hours before CPT. Subjects in study 2 (n = 85) received ketotifen or placebo once 8 hours before CPT. Single-dose efficacy results were used to further qualify a subject as a responder. Responders were re-randomized to a 4-week twice daily dosing regimen with a CPT 8 hours after the final dose. In both studies, ocular symptoms were assessed at three time points 3 to 15 minutes after challenge. There were no significant differences in adverse events between groups.For both studies, ocular itching and vascular injection were significantly reduced (P.003) at all time points after instillation of ketotifen, with a maximum reduction at 7 minutes postchallenge. In study 2, chemosis, tearing, and lid swelling were also assessed and were significantly reduced (P.008) after instillation of ketotifen.Ketotifen 0.025% eye drops were safe and statistically effective in preventing ocular itching, injection, and other signs and symptoms of allergic conjunctivitis at 15 minutes, 6 hours, and 8 hours after a single dose and at 8 hours after the final dose of a 4-week twice daily regimen.

Purpose: To evaluate the effectiveness and safety of olopatadine hydrochloride and to determine its optimal concentration and the onset and duration of action for treating allergic conjunctivitis. Olopatadine is a new topical ophthalmic antiallergic agent that demonstrates activity as both an antihistamine and a mast cell stabilizer. Two double-masked, randomized, placebo-controlled, contralateral eye comparison studies were conducted using the conjunctival allergen challenge model. Methods: A total of 169 subjects received 0.05% or 0.1% olopatadine. Study subjects were healthy adult men and women with a history of active allergic conjunctivitis within the previous two seasons but not receiving current treatment. With an allergen dose that produced signs and symptoms of allergic conjunctivitis at visits 1 and 2, the conjunctival allergen challenge was performed 27 minutes after study drug administration at the third visit (onset-of-action challenge) and at 8 hours after study drug administration at the fourth visit (duration-of-action challenge). Olopatadine was administered in one eye and placebo in the opposite eye. Itching and redness were scored for both eyes at 3, 10, and 20 minutes after the conjunctival allergen challenge. Results: Both 0.05% and 0.1% concentrations of olopatadine were significantly (P < .05) more effective than placebo in inhibiting itching and redness at all evaluations when administered 27 minutes or 8 hours before the conjunctival allergen challenge. There were no serious or drug-related ocular or nonocular adverse events in either study. Conclusion: These findings demonstrate the rapid and prolonged (at least 8 hours) ocular antiallergic action of olopatadine.

To evaluate the effectiveness of bepotastine besilate ophthalmic solutions 1.0% and 1.5% compared with placebo at reducing ocular itching and conjunctival hyperemia in the conjunctival allergen challenge (CAC) model of allergic conjunctivitis.Prospective, double-masked, randomized, placebo-controlled, phase 3 CAC clinical trial.This multicenter trial enrolled 130 subjects with a clinical history of allergic conjunctivitis who were randomized to bepotastine besilate ophthalmic solution 1.0%, 1.5%, or 0.0% (placebo). One drop of test agent was instilled bilaterally before a CAC test evaluating responses at 15 minutes, 8 hours, or 16 hours after test agent instillation. Primary efficacy outcomes were unit improvements relative to placebo in mean scores for ocular itching and conjunctival hyperemia, each graded on 0- to 4-unit scales.Reductions of 1.2 units or more in mean ocular itching scores at all time points for both bepotastine besilate ophthalmic solutions 1.0% and 1.5% were observed at onset of action and 8-hour duration-of-action CAC tests (P.0001). Statistically significant reductions in conjunctival hyperemia (Por = .0125) were observed for bepotastine besilate ophthalmic formulations only at the onset of action CAC test.Bepotastine besilate ophthalmic solutions 1.0% and 1.5% both substantially decreased CAC-induced ocular itching for at least 8 hours after dosing. Reductions in conjunctival hyperemia after a CAC, although statistically significant for bepotastine besilate ophthalmic solutions 1.0% and 1.5% compared with placebo when assessed at 15 minutes after dosing, were modest.

In two independent studies including 25 subjects each, naphazoline caused significant whitening (but did not prevent itching) in the histamine-induced red, itchy eye. Antazoline inhibited itching (but not redness) to a significant degree in the same model. The combination of naphazoline and antazoline produced significant whitening and inhibition of itching in all eyes challenged by histamine. The combination of the two drugs was more effective than either component alone in preventing redness. The antihistamine and combination of antihistamine/vasoconstrictor were equally effective in arresting itching.

We evaluated various technical aspects of tear collection to assess their influence on the measurement of tear histamine levels. We included several methods of collecting tears, storage of tears with and without freezing, storage for three vs ten days, and removal vs nonremoval of cells before freezing. We assayed tear samples in various groups of people with inflamed eyes. None of the various means of collecting or storing the tear samples influenced the histamine measured. The measuring technique is a stable one that requires minimal treatment of samples before assay. To date, we have found that only patients with vernal conjunctivitis have elevated tear histamine levels. Any increase of tear histamine over 10 ng/ml (geometric mean plus 2 S.D.) or any significant decrease is probably related to the disease itself and not to factors related to the technique used to measure tear histamine.

We measured the levels of major basic protein and Charcot-Leyden crystal protein in tears from patients with ventral keratoconjunctivitis or miscellaneous inflammatory or noninflammatory ocular conditions, and from normal subjects. Patients with vernal keratoconjunctivitis had significantly increased levels of both proteins in their tears compared with the other subjects tested; levels of major basic protein seemed to correlate with the severity of the disease. The levels of Charcot-Leyden crystal protein paralleled those of major basic proteins.

The size, weight, and plasma cell content of main and accessory lacrimal glands were examined and compared to the number of plasma cells in the conjunctiva. There were from four to 35 accessory lacrimal glands in the upper conjunctiva and a rare accessory gland in the lower conjunctiva. The total accessory gland mass was approximately one tenth of the lacrimal gland mass although the number of plasma cells was approximately 1/20 of the mass. The number of plasma-cells in the lacrimal gland was estimated to be 3,200,000; in the conjunctiva, 2,100,000; and for the accessory glands, 180,000. Because of the many plasma cells in the relatively inaccessible lacrimal gland, cells of the lymphatic series may home to the lacrimal gland by non-antigenic mechanisms.

We investigated the effect of the calcium channel blocker verapamil on intraocular pressure in human volunteers. In the initial trial, 15 subjects with untreated ocular hypertension were tested. After a baseline measurement was obtained with applanation tonometry, a 40-microliter drop of verapamil, 1.25 mg/ml, was instilled in one eye. After 30 minutes, a second reading was taken. In a subsequent trial of 12 untreated ocular hypertensive subjects, the duration of action was determined using the same dose and method of delivery. Results showed that verapamil elicited a mean +/- S.E.M. change in intraocular pressure of -3.8 +/- 0.900 mm Hg in the treated eye, and -1.6 +/- 0.400 mm Hg in the untreated eye. This reduction was statistically different in both eyes (treated eye, P = .0007; untreated eye, P = .005). This decrease in intraocular pressure remained statistically significant when compared to predrug baseline values for up to ten hours.

Prostaglandin D 2 is a secondary mast cell mediator that causes redness, chemosis, mucous discharge, and eosinophil chemotaxis in the eye. It may play an important role in allergic ocular disease. Although histamine is a key mediator of allergic inflammation, antihistamine therapy provides only symptomatic relief. We added aspirin therapy to the treatment regimen of three patients with vernal conjunctivitis. Aspirin acetylates the enzyme cyclo-oxygenase, thereby preventing the formation of prostaglandin D 2 . Within two weeks after initiation of aspirin therapy, we noted dramatic improvement in conjunctival and episcleral redness and resolution of keratitis and limbal infiltration. We recommend a trial of oral aspirin as adjunctive therapy for intractable cases of vernal conjunctivitis.

We analyzed the blinking motions of ten patients with inferior punctate keratopathy and ten normal subjects by means of time-lapse motion pictures. We also determined the frequency of blinking during one-minute intervals for each individual. Four types of blinking were distinguished: complete, incomplete, twitch, and forced blink. The average blinking frequency was about the same for both groups: 16 to 17 blinks per minute. The relative proportion of complete blinks, however, was much lower in patients with inferior punctate keratopathy than in normal subjects. The impaired blinking motion may be responsible for the punctate staining of the inferior corneal epithelium by producing exposure and inadequacies in the tear film. For this reason, these patients may benefit from blink training, application of tear substitutes, or soft contact lenses more than from the customary prescription of topical cortisone eyedrops.

We compared the tear pH values of 44 normal, healthy volunteers, 20 patients with ocular disorders other than rosacea, seven patients with untreated, active ocular rosacea, and five patients with tetracycline-treated ocular rosacea. The group with untreated, active ocular rosacea had significantly more alkaline tear pH values than the other groups tested. In patients with tetracycline-treated ocular rosacea, tear pH values were not significantly different from those of normal subjects.

Tear samples from 13 normal volunteers and nine patients with vernal conjunctivitis were assayed for histamine. Tears in both groups contained histamine. The normal subjects had values ranging from 2.2 to 36 ng/ml with a mean of 10.3 ng/ml. The vernal patients had histamine values ranging from 0 to 125 ng/ml with a mean of 3,.2 ng/ml. The presence of histamine in tears indicates a role for this important mediator in both the physiologic and immunologic processes of the external eye.

A 35-year-old woman who had undergone bilateral penetrating corneal grafts for keratoconus had keratoconus in the eye that had received a graft 16 years earlier. A second penetrating keratoplasty was performed, and the excised button was examined with light and electron microscopy. Both the light and electron microscopic findings were consistent with the clinical diagnosis of keratoconus. Keratoconus in a graft for the same disease should be added to the list of late complications of successful keratoplasties.

Topical application of the nonimmune selective mast-cell degranulating agent, compound 48/80, produced the signs and symptoms of ocular allergy (itching, injection, chemosis, and mucous discharge) in eight guinea pigs, eight rabbits, and nine humans. The histamine H1 receptor antagonist, antazoline phosphate, blocked itching but not vasodilation in five humans pretreated with compound 48-80. This suggests that histamine was one of the mediators released by compound 48-80-induced degranulation. Compound 48-80 may be helpful in evaluating the effects of therapeutic agents capable of modifying mast-cell degranulation and in the study of mediators involved in external ocular inflammation.

than other lens solution preservatives, may be the most highly sensitizing of the preservatives. The lesions resembling Trantas dots in our patient represent an IgE-mediated or possibly a toxic reaction to chlorhexidine used as a preservative in the contact lens soaking solution. When contact lens wear is associated with redness and ocular irritation, hypersensitivity to chlorhexidine should be considered. Lens care for the hypersensitive patient should consist of lens storage in a sterile, unit-dose preservative free saline.