The purpose of this study is to evaluate the efficacy and safety of four doses of PRO-118 ophthalmic solution ophthalmic solution compared with placebo, for the treatment of seasonal (SAC) and perennial (PAC) allergic conjunctivitis.
A phase II, double-masked, randomized, placebo-controlled, parallel-group and multicenter clinical trial, to evaluate and compared the clinical efficacy and safety of four doses of PRO-118 ophthalmic solution ( PRO-118 0.015% qd, PRO-118 0.015% twice daily , PRO-118 0.020% qd, PRO-118 0.020% twice daily) for the treatment of seasonal (SAC) and perennial (PAC) allergic conjunctivitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
PRO-118 Ophthalmic Solution 0.015 % applied qd during 21 days
PRO-118 Ophthalmic Solution 0.015 % applied twice to day during 21 days
PRO-118 Ophthalmic Solution 0.020 % applied qd during 21 days
Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"
Guadalajara, Jalisco, Mexico
"Instituto de Oftalmología Fundación Conde de Valenciana, I.A.P
Mexico City, Mexico
Efficacy of PRO-118 ophthalmic solution.
Primary efficacy measure: Evaluation of ocular itching. Secondary efficacy measures: Evaluation of symptoms(redness eye,ocular irritation, foreign body sensation, photophobia and lacrimation) and signs(conjunctival hyperaemia,chemosis, mucous discharge ocular and presence of follicles/papillae).
Time frame: 21 days.
Safety of PRO-118 Ophthalmic Solution.
* Evaluation of ocular symptoms and signs, visual acuity (VA), biomicroscopy, intraocular pressure (IOP), funduscopy and cup disc-ratio. * Frequency, severity and relationship to study medication of all adverse events occurring during the course of the study.
Time frame: 21 days.
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PRO-118 Ophthalmic Solution 0.020 % applied twice to day during 21 days
Placebo Ophthalmic Solution applied qd during 21 days