Allergic Conjunctivitis
Conditions
Brief summary
The present study will be carried out to evaluate the antiallergic efficacy of Bepotastine besilate 1.5% free of preservatives versus standard treatment with 0.2% Olopatadine hydrochloride with 0.1% benzalkonium chloride as preservative in adult patients diagnosed with allergic conjunctivitis. The antiallergic efficacy will be evaluated by the reduction of ocular signs and symptoms and by the resolution of non-ocular symptoms (rhinorrhea, congestion, and nasal pruritus), as well as the effect of the preservative and its relationship with the cytotoxicity of the ocular surface. Also will evaluate the safety of both products.
Interventions
DRUGBepotastine Besilate 1.5% PF
Bepotastine besilate 1,5% Preservative free ophthalmic solution
DRUGOlopatadine Hydrochloride 0.2% BAK
Olopatadine hydrochloride 0.2% with BAK as preservative
Sponsors
Laboratorios Poen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
MULTICENTRIC, DOUBLE BLIND, RANDOMIZED, CONTROLLED, 60 DAYS, GROUP PARALLEL GROUPS, TO SHOW SUPERIORITY.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients older than 18 years old. * Clinical diagnosis of allergic conjunctivitis and active allergy with at least 2 points on itching and hyperemia scale. * Patients with history of allergic conjunctivitis. * Patients who accept no to wear contact lens during the duration of the trial. * Patients who accept no to use any other medication by any delivery route. * Patients with intraocular pressure controlled (less than 18 mmhg)
Exclusion criteria
* Patients who have undergone refractive surgery within the 6 months prior to the start of the study * Patient with ocular or systemic active diseases * Patients who are participating in another trial * Patients who have used eye medication in the last 15 days and/or who have received anti-inflammatory drugs (corticosteroids and/or NSAIDs) and/or antihistamines by mouth or intravenous. * Patients hypersensitive to any component of the products: Bepotastine besilate, sodium chloride, monosodium phosphate dihydrate, sodium hydroxide, Olopatadine hydrochloride, benzalkonium chloride, dibasic sodium phosphate, hydrochloric acid, edetate disodium or povidone K29 / 32. * Women who are breastfeeding and pregnant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular itching | Baseline, Day 15, Day 30, Day 45, Day 60 | Change of 1 point of scale 0-3 (none, mild, moderate, severe) in at least 1 visit between gruops. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Eye discharge | Baseline, Day 15, Day 30, Day 45, Day 60 | Differences between treatments. Scale 0-3 (none, mild, moderate, severe) |
| Conjuctival impression cytology | Baseline, Day 30, Day 60 | Differences between treatments. Nelson classification. |
| Adverse reactions | Baseline, Day 15, Day 30, Day 45, Day 60. | — |
| Eye burning | Baseline, Day 15, Day 30, Day 45, Day 60 | Differences between treatments. Scale 0-3 (none, mild, moderate, severe) |
| Eye lacrimation | Baseline, Day 15, Day 30, Day 45, Day 60 | Differences between treatments. Scale 0-3 (none, mild, moderate, severe) |
| Foreign body sensation | Baseline, Day 15, Day 30, Day 45, Day 60 | Differences between treatments. Scale 0-3 (none, mild, moderate, severe) |
| Chemosis | Baseline, Day 15, Day 30, Day 45, Day 60 | Differences between treatments. Scale 0-3 (none, mild, moderate, severe) |
| Nasal congestion | Baseline, Day 15, Day 30, Day 45, Day 60 | Differences between treatments. Scale 0-3 (none, mild, moderate, severe) |
| Nasal pruritus | Baseline, Day 15, Day 30, Day 45, Day 60 | Differences between treatments. Scale 0-3 (none, mild, moderate, severe) |
| Eyelid swelling | Baseline, Day 15, Day 30, Day 45, Day 60 | Differences between treatments. Scale 0-3 (none, mild, moderate, severe) |
| Visual Acuity | Baseline and Day 60 | Improve from baseline. |
| Meniscus height | Baseline, Day 15, Day 30, Day 45, Day 60 | Differences between treatments. |
| Conjunctival hyperemia | Baseline, Day 15, Day 30, Day 45, Day 60 | Differences between treatments. Scale 0-3 (none, mild, moderate, severe) |
| Rhinorrhea | Baseline, Day 15, Day 30, Day 45, Day 60 | Differences between treatments. Scale 0-3 (none, mild, moderate, severe) |
Countries
Argentina
Outcome results
None listed