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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Conjunctivitis, Allergic; Seasonal Allergic Conjunctivitis; Ocular Itching; Ocular Allergy; Perennial Allergic Conjunctivitis
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico, 06800
    • "Instituto de Oftalmología Fundación Conde de Valenciana, I.A.P
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44280
      • Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Laboratorios Sophia S.A de C.V.
• Investigators: Study Director: Leopoldo M Baiza-Durán, MD, Clinical Research Department. Laboratorios Sophia SA de CV; Principal Investigator: María C Jiménez-Martínez, MD, "Instituto de Oftalmología Fundación Conde de Valenciana, I.A.P."; Principal Investigator: Concepción Santacruz-Valdés, MD, "Instituto de Oftalmología Fundación Conde de Valenciana, I.A.P."; Principal Investigator: Emma T Villaseñor-Fierro, MD, Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"; Principal Investigator: Miriam Becerra-Cotta, MD, Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: February 21, 2012
• First Submitted That Met QC Criteria: February 29, 2012
• First Posted (Estimate): March 1, 2012

Study Record Updates

• Last Update Posted (Actual): October 2, 2018
• Last Update Submitted That Met QC Criteria: October 1, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Ocular Allergy.; Seasonal Allergic Conjunctivitis; Perennial Allergic Conjunctivitis; Conjunctivitis, Allergic; Ocular Antihistamines.
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Hypersensitivity; Conjunctival Diseases; Conjunctivitis; Conjunctivitis, Allergic; Ophthalmic Solutions; Pharmaceutical Solutions
• Other Study ID Numbers: LVO1209FII; PRO-118