NEWS HIGHLIGHTS
Published Studies Related to Elestat (Epinastine Ophthalmic)
Efficacy of olopatadine HCI 0.1%, ketotifen fumarate 0.025%, epinastine HCI 0.05%, emedastine 0.05% and fluorometholone acetate 0.1% ophthalmic solutions for seasonal allergic conjunctivitis: a placebo-controlled environmental trial. [2009.08]
PURPOSE: We aimed to compare the clinical efficacy and ocular surface variables of olopatadine, ketotifen fumarate, epinastine, emedastine and fluorometholone acetate ophthalmic solutions in preventing the signs and symptoms of seasonal allergic conjunctivitis (SAC)... CONCLUSIONS: In patients with SAC, olopatadine, ketotifen, epinastine and emedastine are more efficacious than fluorometholone acetate in preventing itching and redness. All the antiallergic agents gave similar results in terms of reducing tearing, chemosis and eyelid swelling. Our data showed that impression cytology parameters improved after treatment with antiallergic agents in patients with SAC.
Efficacy of olopatadine HCI 0.1%, ketotifen fumarate 0.025%, epinastine HCI 0.05%, emedastine 0.05% and fluorometholone acetate 0.1% ophthalmic solutions for seasonal allergic conjunctivitis: a placebo-controlled environmental trial. [2008.07.08]
Purpose: We aimed to compare the clinical efficacy and ocular surface variables of olopatadine, ketotifen fumarate, epinastine, emedastine and fluorometholone acetate ophthalmic solutions in preventing the signs and symptoms of seasonal allergic conjunctivitis (SAC)... Our data showed that impression cytology parameters improved after treatment with antiallergic agents in patients with SAC.
An open-label, investigator-masked, crossover study of the ocular drying effects of two antihistamines, topical epinastine and systemic loratadine, in adult volunteers with seasonal allergic conjunctivitis. [2007.04]
BACKGROUND: Systemic antihistamines such as loratadine are efficacious in the treatment of many allergic conditions. However, their use has been associated with drying effects, particularly of the ocular surface. Objective: The purpose of this study was to compare the ocular drying effects of topical treatment with epinastine hydrochloride ophthalmic solution 0.05 % twice daily and systemic treatment with loratadine 10 mg once daily in patients with seasonal allergic conjunctivitis through the use of several standard clinical tests for dry eye... CONCLUSIONS: These healthy adult volunteers with a history of seasonal allergic conjunctivitis had no clinical signs of ocular drying after 4 days of twice-daily treatment with topical epinastine. After 4 days of once-daily dosing, systemic loratadine was associated with clinical signs of ocular dryness, including decreased tear volume and tear flow. Use of loratadine was also associated with an increase in global fluorescein staining, indicating an increase in ocular surface damage.
Clinical efficacy of olopatadine vs epinastine ophthalmic solution in the conjunctival allergen challenge model. [2004.08]
CONCLUSION: Olopatadine is significantly more effective than epinastine in controlling itching, redness and chemosis associated with allergic conjunctivitis in the CAC model.
Efficacy and tolerability of ophthalmic epinastine assessed using the conjunctival antigen challenge model in patients with a history of allergic conjunctivitis. [2004.01]
BACKGROUND: Epinastine hydrochloride is a nonsedating antihistamine with a high affinity for histamine H(1) receptors, together with mast cell-stabilizing and anti-inflammatory activities. OBJECTIVE: The aim of this study was to assess the efficacy and tolerability of topically administered ophthalmic epinastine using the conjunctival antigen challenge (CAC) model in patients with a history of allergic conjunctivitis... CONCLUSIONS: In this CAC model, multiple signs and symptoms of allergic conjunctivitis were significantly reduced by instillation of epinastine compared with vehicle. Epinastine showed prompt onset (3 minutes) and long duration of action (>or=8 hours). The tolerability of epinastine was similar to that of vehicle.
Clinical Trials Related to Elestat (Epinastine Ophthalmic)
Two Formulations and Concentrations of Epinastine Nasal Spray Versus Azelastine Nasal Solution for Allergic Rhinitis [Completed]
The objectives of this study were to:
- Examine the tolerability of two formulations and two dose concentrations of epinastine.
- Select formulation(s) of epinastine for future studies by evaluating the individual
sensory attribute scores of the Nasal Spray Evaluation Questionnaire (NSEQ) collected
after each study drug administration and the subject preference ranking assessed at the
completion of the study.
- Compare the preference of two formulations and two dose concentrations of epinastine
compared to azelastine following a single dose of each in a randomized, double-blind,
two-cohort, three-period crossover design.
WAL 801 CL Dry Syrup in Pediatric Atopic Dermatitis Patients [Completed]
The safety and efficacy of WAL 801 CL (epinastine hydrochloride) Dry Syrup in the treatment
of atopic dermatitis in children was evaluated and plasma drug concentrations were measured.
Relative Bioavailability of Epinastine Syrup Compared to Tablets in Healthy Volunteers [Completed]
To assess the bioequivalence of two galenic formulations for epinastine (Flurinol®): syrup
and 20 mg tablets
Epinastine and Pseudoephedrine Fixed Combination Compared to Separate Administration in Healthy Volunteers [Completed]
Study to compare the bioavailable fraction of epinastine and pseudoephedrine when
administered as a fixed dose combination in tablet form (new pharmaceutical formulation),
with that obtained with each of these drugs when administered separately to healthy
volunteers.
Bioequivalence of the New Formulation of WAL 801 CL Dry Syrup Compared to the Conventional Formulation of WAL 801 CL Dry Syrup in Healthy Male Volunteers [Completed]
To establish the bioequivalence of the new formulation of WAL 801 CL dry syrup vs. the
conventional formulation of WAL 801 CL dry syrup
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