Efficacy and Safety of PRO-118 Ophthalmic Solution in Allergic Conjunctivitis

Study Overview
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Brief Summary
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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
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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.

Official Title
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STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PRO-118 OPHTHALMIC SOLUTION IN ALLERGIC CONJUNCTIVITIS

Conditions
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Ocular Itching, Ocular Allergy, Seasonal Allergic Conjunctivitis, Perennial Allergic Conjunctivitis, Conjunctivitis, Allergic

Intervention / Treatment
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* Drug: PRO-118 Ophthalmic Solution 0.015%
* Drug: PRO-118 Ophthalmic Solution 0.015 %
* Drug: PRO-118 Ophthalmic Solution 0.020 %
* Drug: PRO-118 Ophthalmic Solution 0.020 %
* Drug: Placebo Ophthalmic Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A. PRO-118/Placebo 0.015%,0.020%<br> | Drug: PRO-118 Ophthalmic Solution 0.015%<br>* PRO-118 Ophthalmic Solution 0.015 % applied qd during 21 days<br>|
| Experimental: Arm B. PRO-118/Placebo 0.015%,0.020%<br> | Drug: PRO-118 Ophthalmic Solution 0.015 %<br>* PRO-118 Ophthalmic Solution 0.015 % applied twice to day during 21 days<br>|
| Experimental: Arm C. PRO-118/Placebo 0.015%,0.020%<br> | Drug: PRO-118 Ophthalmic Solution 0.020 %<br>* PRO-118 Ophthalmic Solution 0.020 % applied qd during 21 days<br>|
| Experimental: Arm D. PRO-118/Placebo 0.015%,0.020%<br> | Drug: PRO-118 Ophthalmic Solution 0.020 %<br>* PRO-118 Ophthalmic Solution 0.020 % applied twice to day during 21 days<br>|
| Placebo Comparator: Arm E PRO-118/Placebo 0.015%,0.020%<br> | Drug: Placebo Ophthalmic Solution<br>* Placebo Ophthalmic Solution applied qd during 21 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 21 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 21 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ocular Allergy., Seasonal Allergic Conjunctivitis, Perennial Allergic Conjunctivitis, Conjunctivitis, Allergic, Ocular Antihistamines.