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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
97
Bepotastine besilate 1,5% Preservative free ophthalmic solution
Olopatadine hydrochloride 0.2% with BAK as preservative
Hospital de Alta Complejidad El Cruce - Nestor Kirchner
CABA, Argentina
Hospital Santa Lucía
CABA, Argentina
Instituto Oftalmológico Pedro Lagleyze
CABA, Argentina
Hospital Churruca - Visca
CABA, Argentina
Ocular itching
Change of 1 point of scale 0-3 (none, mild, moderate, severe) in at least 1 visit between gruops.
Time frame: Baseline, Day 15, Day 30, Day 45, Day 60
Eye burning
Differences between treatments. Scale 0-3 (none, mild, moderate, severe)
Time frame: Baseline, Day 15, Day 30, Day 45, Day 60
Eye lacrimation
Differences between treatments. Scale 0-3 (none, mild, moderate, severe)
Time frame: Baseline, Day 15, Day 30, Day 45, Day 60
Foreign body sensation
Differences between treatments. Scale 0-3 (none, mild, moderate, severe)
Time frame: Baseline, Day 15, Day 30, Day 45, Day 60
Rhinorrhea
Differences between treatments. Scale 0-3 (none, mild, moderate, severe)
Time frame: Baseline, Day 15, Day 30, Day 45, Day 60
Nasal congestion
Differences between treatments. Scale 0-3 (none, mild, moderate, severe)
Time frame: Baseline, Day 15, Day 30, Day 45, Day 60
Nasal pruritus
Differences between treatments. Scale 0-3 (none, mild, moderate, severe)
Time frame: Baseline, Day 15, Day 30, Day 45, Day 60
Eyelid swelling
Differences between treatments. Scale 0-3 (none, mild, moderate, severe)
Time frame: Baseline, Day 15, Day 30, Day 45, Day 60
Visual Acuity
Improve from baseline.
Time frame: Baseline and Day 60
Meniscus height
Differences between treatments.
Time frame: Baseline, Day 15, Day 30, Day 45, Day 60
Conjunctival hyperemia
Differences between treatments. Scale 0-3 (none, mild, moderate, severe)
Time frame: Baseline, Day 15, Day 30, Day 45, Day 60
Chemosis
Differences between treatments. Scale 0-3 (none, mild, moderate, severe)
Time frame: Baseline, Day 15, Day 30, Day 45, Day 60
Eye discharge
Differences between treatments. Scale 0-3 (none, mild, moderate, severe)
Time frame: Baseline, Day 15, Day 30, Day 45, Day 60
Conjuctival impression cytology
Differences between treatments. Nelson classification.
Time frame: Baseline, Day 30, Day 60
Adverse reactions
Time frame: Baseline, Day 15, Day 30, Day 45, Day 60.
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