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

Sponsor

Laboratorios Sophia S.A de C.V. (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT01541904

Collaborator

(none)

Enrollment

Locations

Arms

11.1

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ocular Itching Ocular Allergy Seasonal Allergic Conjunctivitis Perennial Allergic Conjunctivitis Conjunctivitis, Allergic	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	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2011

Actual Primary Completion Date :

Feb 1, 2012

Actual Study Completion Date :

Feb 1, 2012

Arms and Interventions

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
Experimental: Arm D. PRO-118/Placebo 0.015%,0.020%	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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"	Guadalajara	Jalisco	Mexico	44280
2	"Instituto de Oftalmología Fundación Conde de Valenciana, I.A.P	Mexico City		Mexico	06800

Sponsors and Collaborators

Laboratorios Sophia S.A de C.V.

Investigators

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 Director: Leopoldo M Baiza-Durán, MD, Clinical Research Department. Laboratorios Sophia SA de CV