Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04776096
Status:
COMPLETED
Last Update Posted:
2022-12-15
First Post:
2021-02-25
Brief Title:
Efficacy and Toxicity of Bepotastine 15 PF vs Olopatadine 02 With BAK on Allergic Conjunctivitis Treatment
Sponsor:
Laboratorios Poen
Organization:
Laboratorios Poen
Study Overview
Official Title:
PHASE IV MULTICENTRIC DOUBLE-BLIND RANDOMIZED CONTROLLED60 DAYS PARALLEL GROUPS SUPERIORITY STUDY TO COMPARE THE EFFECTIVENESS AND TOXICITY OF BEPOTASTINE 15 PF vs OLOPATADINE 02 WITH BAK IN TREATMENT OF ALLERGIC CONJUNCTIVITIS
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The present study will be carried out to evaluate the antiallergic efficacy of Bepotastine besilate 15 free of preservatives versus standard treatment with 02 Olopatadine hydrochloride with 01 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None