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

This study has suspended participant recruitment.
(Reformulation)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01541904
First Posted: March 1, 2012
Last Update Posted: June 5, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Laboratorios Sophia S.A de C.V.
  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: Placebo Ophthalmic Solution Phase 2

Study Type: Interventional
Study Design: 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

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. ]

    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. ]
    • 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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Laboratorios Sophia S.A de C.V.
ClinicalTrials.gov Identifier: NCT01541904     History of Changes
Other Study ID Numbers: LVO1209FII
PRO-118
First Submitted: February 21, 2012
First Posted: March 1, 2012
Last Update Posted: June 5, 2013
Last Verified: June 2013

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:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pharmaceutical Solutions
Ophthalmic Solutions


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