Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-29 @ 5:20 AM
Study NCT ID:
NCT01541904
Status:
WITHDRAWN
Last Update Posted:
2018-10-02
First Post:
2012-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of PRO-118 Ophthalmic Solution in Allergic Conjunctivitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003233', 'term': 'Conjunctivitis, Allergic'}], 'ancestors': [{'id': 'D003231', 'term': 'Conjunctivitis'}, {'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Reformulation', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-01', 'studyFirstSubmitDate': '2012-02-21', 'studyFirstSubmitQcDate': '2012-02-29', 'lastUpdatePostDateStruct': {'date': '2018-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-03-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of PRO-118 ophthalmic solution.', 'timeFrame': '21 days.', 'description': 'Primary efficacy measure: Evaluation of ocular itching.\n\nSecondary 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).'}], 'secondaryOutcomes': [{'measure': 'Safety of PRO-118 Ophthalmic Solution.', 'timeFrame': '21 days.', 'description': '* Evaluation of ocular symptoms and signs, visual acuity (VA), biomicroscopy, intraocular pressure (IOP), funduscopy and cup disc-ratio.\n* Frequency, severity and relationship to study medication of all adverse events occurring during the course of the study.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Ocular Allergy.', 'Seasonal Allergic Conjunctivitis', 'Perennial Allergic Conjunctivitis', 'Conjunctivitis, Allergic', 'Ocular Antihistamines.'], 'conditions': ['Ocular Itching', 'Ocular Allergy', 'Seasonal Allergic Conjunctivitis', 'Perennial Allergic Conjunctivitis', 'Conjunctivitis, Allergic']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with diagnosis of seasonal or perennial allergic conjunctivitis.\n* Age ≥ 6 years old at screening visit.\n* Male or female patients.\n\nApplicable in patients ≥ 18 years old.\n\n* Patient has signed the Informed Consent Form (ICF) prior to any screening procedures.\n\nApplicable in patients with age ≤ 18 years old.\n\n* Patients Patients'parents or legal guardians signed an Informed Consent Form (ICF).\n* The patients also provided written assent.\n\nExclusion Criteria:\n\n* Presence of any form of allergic conjunctivitis other than seasonal or perennial allergic conjunctivitis (Atopic keratoconjunctivitis, giant papillary conjunctivitis).\n* Any other ophthalmic medication within seven days prior to randomization.\n* Patient with one blind eye.\n* Visual acuity of 20/40 in any eye.\n* Patients with history of active stage of any other concomitant ocular disease.\n* Contraindications or sensitivity to any component of the study treatments.\n* Contact lens users.\n* Ocular surgery within the past 3 months.\n* Women who were not using an effective means of contraception or who were pregnant or nursing.\n* Participation in any studies of investigational drugs within 90 days previous to the inclusion.\n\nDiscontinuation criteria:\n\n* 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."}, 'identificationModule': {'nctId': 'NCT01541904', 'acronym': 'PRO-118', 'briefTitle': 'Efficacy and Safety of PRO-118 Ophthalmic Solution in Allergic Conjunctivitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratorios Sophia S.A de C.V.'}, 'officialTitle': 'STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PRO-118 OPHTHALMIC SOLUTION IN ALLERGIC CONJUNCTIVITIS', 'orgStudyIdInfo': {'id': 'LVO1209FII'}, 'secondaryIdInfos': [{'id': 'PRO-118'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A. PRO-118/Placebo 0.015%,0.020%', 'interventionNames': ['Drug: PRO-118 Ophthalmic Solution 0.015%']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B. PRO-118/Placebo 0.015%,0.020%', 'interventionNames': ['Drug: PRO-118 Ophthalmic Solution 0.015 %']}, {'type': 'EXPERIMENTAL', 'label': 'Arm C. PRO-118/Placebo 0.015%,0.020%', 'interventionNames': ['Drug: PRO-118 Ophthalmic Solution 0.020 %']}, {'type': 'EXPERIMENTAL', 'label': 'Arm D. PRO-118/Placebo 0.015%,0.020%', 'interventionNames': ['Drug: PRO-118 Ophthalmic Solution 0.020 %']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm E PRO-118/Placebo 0.015%,0.020%', 'interventionNames': ['Drug: Placebo Ophthalmic Solution']}], 'interventions': [{'name': 'PRO-118 Ophthalmic Solution 0.015%', 'type': 'DRUG', 'description': 'PRO-118 Ophthalmic Solution 0.015 % applied qd during 21 days', 'armGroupLabels': ['Arm A. PRO-118/Placebo 0.015%,0.020%']}, {'name': 'PRO-118 Ophthalmic Solution 0.015 %', 'type': 'DRUG', 'description': 'PRO-118 Ophthalmic Solution 0.015 % applied twice to day during 21 days', 'armGroupLabels': ['Arm B. PRO-118/Placebo 0.015%,0.020%']}, {'name': 'PRO-118 Ophthalmic Solution 0.020 %', 'type': 'DRUG', 'description': 'PRO-118 Ophthalmic Solution 0.020 % applied qd during 21 days', 'armGroupLabels': ['Arm C. PRO-118/Placebo 0.015%,0.020%']}, {'name': 'PRO-118 Ophthalmic Solution 0.020 %', 'type': 'DRUG', 'description': 'PRO-118 Ophthalmic Solution 0.020 % applied twice to day during 21 days', 'armGroupLabels': ['Arm D. PRO-118/Placebo 0.015%,0.020%']}, {'name': 'Placebo Ophthalmic Solution', 'type': 'DRUG', 'description': 'Placebo Ophthalmic Solution applied qd during 21 days', 'armGroupLabels': ['Arm E PRO-118/Placebo 0.015%,0.020%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44280', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '06800', 'city': 'Mexico City', 'country': 'Mexico', 'facility': '"Instituto de Oftalmología Fundación Conde de Valenciana, I.A.P', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'overallOfficials': [{'name': 'María C Jiménez-Martínez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '"Instituto de Oftalmología Fundación Conde de Valenciana, I.A.P."'}, {'name': 'Concepción Santacruz-Valdés, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '"Instituto de Oftalmología Fundación Conde de Valenciana, I.A.P."'}, {'name': 'Emma T Villaseñor-Fierro, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"'}, {'name': 'Miriam Becerra-Cotta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"'}, {'name': 'Leopoldo M Baiza-Durán, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Clinical Research Department. Laboratorios Sophia SA de CV'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratorios Sophia S.A de C.V.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}