Efficacy and Safety of PRO-118 Ophthalmic Solution in Allergic Conjunctivitis
- Conditions
- Ocular ItchingOcular AllergySeasonal Allergic ConjunctivitisPerennial Allergic ConjunctivitisConjunctivitis, Allergic
- Interventions
- Drug: PRO-118 Ophthalmic Solution 0.020 %Drug: PRO-118 Ophthalmic Solution 0.015%Drug: PRO-118 Ophthalmic Solution 0.015 %Drug: Placebo Ophthalmic Solution
- Registration Number
- NCT01541904
- Lead Sponsor
- Laboratorios Sophia S.A de C.V.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Patients with diagnosis of seasonal or perennial allergic conjunctivitis.
- Age ≥ 6 years old at screening visit.
- Male or female patients.
Applicable in patients ≥ 18 years old.
- Patient has signed the Informed Consent Form (ICF) prior to any screening procedures.
Applicable in patients with age ≤ 18 years old.
- Patients Patients'parents or legal guardians signed an Informed Consent Form (ICF).
- The patients also provided written assent.
- Presence of any form of allergic conjunctivitis other than seasonal or perennial allergic conjunctivitis (Atopic keratoconjunctivitis, giant papillary conjunctivitis).
- Any other ophthalmic medication within seven days prior to randomization.
- Patient with one blind eye.
- Visual acuity of 20/40 in any eye.
- Patients with history of active stage of any other concomitant ocular disease.
- Contraindications or sensitivity to any component of the study treatments.
- Contact lens users.
- Ocular surgery within the past 3 months.
- Women who were not using an effective means of contraception or who were pregnant or nursing.
- Participation in any studies of investigational drugs within 90 days previous to the inclusion.
Discontinuation criteria:
- Patients could be discontinued before the completion of the study because of use of prohibited medications, adverse events, pregnancy, protocol violations, lack of efficacy, or administrative reasons.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm C. PRO-118/Placebo 0.015%,0.020% PRO-118 Ophthalmic Solution 0.020 % - Arm D. PRO-118/Placebo 0.015%,0.020% PRO-118 Ophthalmic Solution 0.020 % - Arm A. PRO-118/Placebo 0.015%,0.020% PRO-118 Ophthalmic Solution 0.015% - Arm B. PRO-118/Placebo 0.015%,0.020% PRO-118 Ophthalmic Solution 0.015 % - Arm E PRO-118/Placebo 0.015%,0.020% Placebo Ophthalmic Solution -
- Primary Outcome Measures
Name Time Method Efficacy of PRO-118 ophthalmic solution. 21 days. 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).
- Secondary Outcome Measures
Name Time Method Safety of PRO-118 Ophthalmic Solution. 21 days. * 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.
Trial Locations
- Locations (2)
Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"
🇲🇽Guadalajara, Jalisco, Mexico
"Instituto de Oftalmología Fundación Conde de Valenciana, I.A.P
🇲🇽Mexico City, Mexico