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

This study has suspended participant recruitment.
(Reformulation)
Sponsor:
Information provided by (Responsible Party):
Laboratorios Sophia S.A de C.V.
ClinicalTrials.gov Identifier:
NCT01541904
First received: February 21, 2012
Last updated: June 3, 2013
Last verified: June 2013
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PRO-118 OPHTHALMIC SOLUTION IN ALLERGIC CONJUNCTIVITIS

Resource links provided by NLM:


Further study details as provided by Laboratorios Sophia S.A de C.V.:

Primary Outcome Measures:
  • Efficacy of PRO-118 ophthalmic solution. [ Time Frame: 21 days. ] [ Designated as safety issue: No ]

    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. [ Time Frame: 21 days. ] [ Designated as safety issue: Yes ]
    • 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.


Estimated Enrollment: 35
Study Start Date: March 2011
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01541904

Locations
Mexico
"Instituto de Oftalmología Fundación Conde de Valenciana, I.A.P
México, D.F., D.f., Mexico, 06800
Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"
Guadalajara, Jalisco, Mexico, 44280
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
  More Information

No publications provided

Responsible Party: Laboratorios Sophia S.A de C.V.
ClinicalTrials.gov Identifier: NCT01541904     History of Changes
Other Study ID Numbers: LVO1209FII, PRO-118
Study First Received: February 21, 2012
Last Updated: June 3, 2013
Health Authority: México: Mexican Regulatory Agency.
México: Mexico's Health Ministry

Keywords provided by Laboratorios Sophia S.A de C.V.:
Ocular Allergy.
Seasonal Allergic Conjunctivitis
Perennial Allergic Conjunctivitis
Conjunctivitis, Allergic
Ocular Antihistamines.

Additional relevant MeSH terms:
Hypersensitivity
Conjunctivitis
Conjunctivitis, Allergic
Immune System Diseases
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on July 26, 2014