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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bepotastine besilate 1,5% preservative free | Experimental | Bepotastine besilate 1,5% in preservative-free bottle, administered once a day during the morning. |
|
| Olopatadine hydrochloride 0,2% with BAK | Active Comparator | Olopatadine hydrochloride 0,2% with BAK as preservative, administered once a day during the morning. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bepotastine Besilate 1.5% PF | Drug | Bepotastine besilate 1,5% Preservative free ophthalmic solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ocular itching | Change of 1 point of scale 0-3 (none, mild, moderate, severe) in at least 1 visit between gruops. | Baseline, Day 15, Day 30, Day 45, Day 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Eye burning | Differences between treatments. Scale 0-3 (none, mild, moderate, severe) | Baseline, Day 15, Day 30, Day 45, Day 60 |
| Eye lacrimation | Differences between treatments. Scale 0-3 (none, mild, moderate, severe) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Alta Complejidad El Cruce - Nestor Kirchner | CABA | B1888 | Argentina | |||
| Hospital Santa Lucía |
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MULTICENTRIC, DOUBLE BLIND, RANDOMIZED, CONTROLLED, 60 DAYS, GROUP PARALLEL GROUPS, TO SHOW SUPERIORITY.
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| Olopatadine Hydrochloride 0.2% BAK | Drug | Olopatadine hydrochloride 0.2% with BAK as preservative |
|
| Baseline, Day 15, Day 30, Day 45, Day 60 |
| Foreign body sensation | Differences between treatments. Scale 0-3 (none, mild, moderate, severe) | Baseline, Day 15, Day 30, Day 45, Day 60 |
| Rhinorrhea | Differences between treatments. Scale 0-3 (none, mild, moderate, severe) | Baseline, Day 15, Day 30, Day 45, Day 60 |
| Nasal congestion | Differences between treatments. Scale 0-3 (none, mild, moderate, severe) | Baseline, Day 15, Day 30, Day 45, Day 60 |
| Nasal pruritus | Differences between treatments. Scale 0-3 (none, mild, moderate, severe) | Baseline, Day 15, Day 30, Day 45, Day 60 |
| Eyelid swelling | Differences between treatments. Scale 0-3 (none, mild, moderate, severe) | Baseline, Day 15, Day 30, Day 45, Day 60 |
| Visual Acuity | Improve from baseline. | Baseline and Day 60 |
| Meniscus height | Differences between treatments. | Baseline, Day 15, Day 30, Day 45, Day 60 |
| Conjunctival hyperemia | Differences between treatments. Scale 0-3 (none, mild, moderate, severe) | Baseline, Day 15, Day 30, Day 45, Day 60 |
| Chemosis | Differences between treatments. Scale 0-3 (none, mild, moderate, severe) | Baseline, Day 15, Day 30, Day 45, Day 60 |
| Eye discharge | Differences between treatments. Scale 0-3 (none, mild, moderate, severe) | Baseline, Day 15, Day 30, Day 45, Day 60 |
| Conjuctival impression cytology | Differences between treatments. Nelson classification. | Baseline, Day 30, Day 60 |
| Adverse reactions | Baseline, Day 15, Day 30, Day 45, Day 60. |
| CABA |
| C1232AAC |
| Argentina |
| Instituto Oftalmológico Pedro Lagleyze | CABA | C1416 DJI | Argentina |
| Hospital Churruca - Visca | CABA | C1437 | Argentina |
| ID | Term |
|---|---|
| D003233 | Conjunctivitis, Allergic |
| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C511534 | bepotastine besilate |
| D000069605 | Olopatadine Hydrochloride |
| ID | Term |
|---|---|
| D003990 | Dibenzoxepins |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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