Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2025-12-29 @ 7:13 AM
Study NCT ID:
NCT05470868
Status:
COMPLETED
Last Update Posted:
2025-07-17
First Post:
2022-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Tolerability of PRO-185
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009278', 'term': 'Naphazoline'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alejandra.sanchez@sophia.com.mx', 'phone': ':+52 (33) 3001 4200', 'title': 'Alejandra Sanchez-Ríos M.D.', 'organization': 'Laboratorios Sophia'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From day 1 (basal visit) to final visit on day 10 (±1 days)', 'description': "The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.", 'eventGroups': [{'id': 'EG000', 'title': 'PRO-185', 'description': 'Healthy volunteers will apply one drop of PRO-185 ophthalmic solution (naphazoline / hypromellose) on both eyes, QID (four times per day) for 8 days.\n\nNaphazoline / Hypromellose Ophthalmic: Naphazoline 0.03% / Hypromellose 0.2%', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 9, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Burning sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tearing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blurred vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritation in the area of instillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'conjunctival hyperemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'punctate keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Intraocular Pressure (IOP) Increment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}, {'units': 'Eyes (right)', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PRO-185', 'description': 'Healthy volunteers will apply one drop of PRO-185 ophthalmic solution (naphazoline / hypromellose) on both eyes, QID (four times per day) for 8 days.\n\nNaphazoline / Hypromellose Ophthalmic: Naphazoline 0.03% / Hypromellose 0.2%'}], 'classes': [{'title': 'VB IOP (pre-pupil dilation)', 'categories': [{'measurements': [{'value': '14.00', 'spread': '2.17', 'groupId': 'OG000'}]}]}, {'title': 'VB IOP (post-pupil dilation)', 'categories': [{'measurements': [{'value': '13.57', 'spread': '2.75', 'groupId': 'OG000'}]}]}, {'title': 'V1 IOP (pre-research product application)', 'categories': [{'measurements': [{'value': '13.47', 'spread': '2.21', 'groupId': 'OG000'}]}]}, {'title': 'V1 IOP (post-research product application)', 'categories': [{'measurements': [{'value': '13.25', 'spread': '1.90', 'groupId': 'OG000'}]}]}, {'title': 'V2 IOP (pre-research product application)', 'categories': [{'measurements': [{'value': '13.02', 'spread': '2.09', 'groupId': 'OG000'}]}]}, {'title': 'V2 IOP (post-research product application)', 'categories': [{'measurements': [{'value': '13.65', 'spread': '2.63', 'groupId': 'OG000'}]}]}, {'title': 'FV IOP', 'categories': [{'measurements': [{'value': '12.79', 'spread': '2.17', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline visit (BV), day 1(pre and post pupil dilation); Visit 1 (V1), day 3 +1 (pre and post research product application); Visit 2 (V2), day 8 (pre and post research product application); Final Visit, day 10 (+1)', 'description': 'Safety evaluation through the incidence of subjects presenting an IOP elevation comparing Baseline Visit, Final Visit and before and after (20 minutes) research product administration (V1 and V2). Only right-eye values were analyzed.', 'unitOfMeasure': 'mmhg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes (right)', 'denomUnitsSelected': 'Eyes (right)'}, {'type': 'PRIMARY', 'title': 'Heart Rate Increment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PRO-185', 'description': 'Healthy volunteers will apply one drop of PRO-185 ophthalmic solution (naphazoline / hypromellose) on both eyes, QID (four times per day) for 8 days.\n\nNaphazoline / Hypromellose Ophthalmic: Naphazoline 0.03% / Hypromellose 0.2%'}], 'classes': [{'title': 'BV Heart Rate', 'categories': [{'measurements': [{'value': '73.27', 'spread': '11.31', 'groupId': 'OG000'}]}]}, {'title': 'V1 Heart Rate (pre-instillation)', 'categories': [{'measurements': [{'value': '70.54', 'spread': '7.49', 'groupId': 'OG000'}]}]}, {'title': 'V1 Heart Rate (post70.59-instillation)', 'categories': [{'measurements': [{'value': '70.59', 'spread': '6.03', 'groupId': 'OG000'}]}]}, {'title': 'V2 Heart Rate (pre-instillation)', 'categories': [{'measurements': [{'value': '70.68', 'spread': '5.33', 'groupId': 'OG000'}]}]}, {'title': 'V2 Heart Rate (post-instillation)', 'categories': [{'measurements': [{'value': '69.90', 'spread': '4.61', 'groupId': 'OG000'}]}]}, {'title': 'FV Heart Rate', 'categories': [{'measurements': [{'value': '73', 'spread': '9.19', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline visit, day 1(pre and post pupil dilation); Visit 1, day 3 +1 (pre and post research product application); Visit 2, day 8 (pre and post research product application); Final Visit, day 10 (+1)', 'description': 'Safety evaluation through the incidence of subjects presenting an elevation \\> 15 beats per minute 20 minutes after administration, in comparison to baseline value.', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Blood Pressure Increment (Systolic)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PRO-185', 'description': 'Healthy volunteers will apply one drop of PRO-185 ophthalmic solution (naphazoline / hypromellose) on both eyes, QID (four times per day) for 8 days.\n\nNaphazoline / Hypromellose Ophthalmic: Naphazoline 0.03% / Hypromellose 0.2%'}], 'classes': [{'title': 'BV Systolic Blood Pressure', 'categories': [{'measurements': [{'value': '113.81', 'spread': '9.09', 'groupId': 'OG000'}]}]}, {'title': 'V1 Systolic Blood Pressure (pre-instillation)', 'categories': [{'measurements': [{'value': '111.00', 'spread': '12.07', 'groupId': 'OG000'}]}]}, {'title': 'V1 Systolic Blood Pressure (post-instillation)', 'categories': [{'measurements': [{'value': '111.22', 'spread': '10.72', 'groupId': 'OG000'}]}]}, {'title': 'V2 Systolic Blood Pressure (pre-instillation)', 'categories': [{'measurements': [{'value': '107.50', 'spread': '10.40', 'groupId': 'OG000'}]}]}, {'title': 'V2 Systolic Blood Pressure (post-instillation)', 'categories': [{'measurements': [{'value': '108.63', 'spread': '9.21', 'groupId': 'OG000'}]}]}, {'title': 'FV Systolic Blood Pressure', 'categories': [{'measurements': [{'value': '113.90', 'spread': '12.14', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline visit, day 1(pre and post pupil dilation); Visit 1, day 3 +1 (pre and post research product application); Visit 2, day 8 (pre and post research product application); Final Visit, day 10 (+1)', 'description': 'Safety evaluation through the incidence of subjects presenting an elevation \\> 15 mmHg in systolic pressure or \\> 10 mmHg in diastolic pressure 20 minutes after administration, in comparison to baseline value.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Incidence of Conjunctival Hyperemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}, {'units': 'Eyes (right)', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PRO-185', 'description': 'Healthy volunteers will apply one drop of PRO-185 ophthalmic solution (naphazoline / hypromellose) on both eyes, QID (four times per day) for 8 days.\n\nNaphazoline / Hypromellose Ophthalmic: Naphazoline 0.03% / Hypromellose 0.2%'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Trough Day 10 (+1)', 'description': 'Tolerability evaluation through the incidence of conjunctival hyperemia grades 3 and 4 (according to the Efron scale). A higher score (grades) in this scale translates into worse outcomes. Only right-eye values were analyzed.', 'unitOfMeasure': 'Number of participants gde 3 or 4 Hypere', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes (right)', 'denomUnitsSelected': 'Eyes (right)'}, {'type': 'PRIMARY', 'title': 'Incidence of Pharmacological Mydriasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}, {'units': 'Eyes (right)', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PRO-185', 'description': 'Healthy volunteers will apply one drop of PRO-185 ophthalmic solution (naphazoline / hypromellose) on both eyes, QID (four times per day) for 8 days.\n\nNaphazoline / Hypromellose Ophthalmic: Naphazoline 0.03% / Hypromellose 0.2%'}], 'classes': [{'categories': [{'measurements': [{'value': '6.50', 'spread': '0.60', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Trough Day 10 (+1)', 'description': 'Incidence of pharmacological mydriasis measured through OPD III scan. If there was a change greater than 2 mm in pupil diameter between the baseline visit and any of the other measurements, pharmacological mydriasis was considered present, also if there was this change between the pre- and post-examination of the investigational product during visits 1 and 2.', 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes (right)', 'denomUnitsSelected': 'Eyes (right)'}, {'type': 'PRIMARY', 'title': 'Blood Pressure Increment (Diastolic)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PRO-185', 'description': 'Healthy volunteers will apply one drop of PRO-185 ophthalmic solution (naphazoline / hypromellose) on both eyes, QID (four times per day) for 8 days.\n\nNaphazoline / Hypromellose Ophthalmic: Naphazoline 0.03% / Hypromellose 0.2%'}], 'classes': [{'title': 'BV Diastolic Blood Pressure', 'categories': [{'measurements': [{'value': '68.36', 'spread': '8.16', 'groupId': 'OG000'}]}]}, {'title': 'V1 Diastolic Blood Pressure (pre-instillation)', 'categories': [{'measurements': [{'value': '68.40', 'spread': '7.73', 'groupId': 'OG000'}]}]}, {'title': 'V1 Diastolic Blood Pressure (post-instillation)', 'categories': [{'measurements': [{'value': '69.45', 'spread': '7.2', 'groupId': 'OG000'}]}]}, {'title': 'V2 Diastolic Blood Pressure (pre-instillation)', 'categories': [{'measurements': [{'value': '66.59', 'spread': '6.54', 'groupId': 'OG000'}]}]}, {'title': 'V2 Diastolic Blood Pressure (post-instillation)', 'categories': [{'measurements': [{'value': '67.31', 'spread': '7.67', 'groupId': 'OG000'}]}]}, {'title': 'FV Diastolic Blood Pressure', 'categories': [{'measurements': [{'value': '67.41', 'spread': '7.76', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline visit, day 1(pre and post pupil dilation); Visit 1, day 3 +1 (pre and post research product application); Visit 2, day 8 (pre and post research product application); Final Visit, day 10 (+1)', 'description': 'Safety evaluation through the incidence of subjects presenting an elevation \\> 15 mmHg in systolic pressure or \\> 10 mmHg in diastolic pressure 20 minutes after administration, in comparison to baseline value.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PRO-185', 'description': 'Healthy volunteers will apply one drop of PRO-185 ophthalmic solution (naphazoline / hypromellose) on both eyes, QID (four times per day) for 8 days.\n\nNaphazoline / Hypromellose Ophthalmic: Naphazoline 0.03% / Hypromellose 0.2%'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}, {'units': 'Eyes', 'counts': [{'value': '44', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'PRO-185', 'description': 'Healthy volunteers will apply one drop of PRO-185 ophthalmic solution (naphazoline / hypromellose) on both eyes, QID (four times per day) for 8 days.\n\nNaphazoline / Hypromellose Ophthalmic: Naphazoline 0.03% / Hypromellose 0.2%'}], 'measures': [{'title': 'Age, Categorical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}, {'units': 'Eyes', 'counts': [{'value': '44', 'groupId': 'BG000'}]}], 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Age, Continuous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}, {'units': 'Eyes', 'counts': [{'value': '44', 'groupId': 'BG000'}]}], 'classes': [{'categories': [{'measurements': [{'value': '23.82', 'spread': '4.48', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex: Female, Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}, {'units': 'Eyes', 'counts': [{'value': '44', 'groupId': 'BG000'}]}], 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}, {'units': 'Eyes', 'counts': [{'value': '44', 'groupId': 'BG000'}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}, {'units': 'Eyes', 'counts': [{'value': '44', 'groupId': 'BG000'}]}], 'classes': [{'title': 'Mexico', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Intraocular Pressure (IOP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}, {'units': 'Eyes', 'counts': [{'value': '44', 'groupId': 'BG000'}]}], 'classes': [{'categories': [{'measurements': [{'value': '14.00', 'spread': '2.80', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmhg', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Eyes'}, {'title': 'Pupillary diameter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}, {'units': 'Eyes', 'counts': [{'value': '44', 'groupId': 'BG000'}]}], 'classes': [{'categories': [{'measurements': [{'value': '6.50', 'spread': '0.47', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'millimeters', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Eyes'}], 'typeUnitsAnalyzed': 'Eyes', 'populationDescription': "The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol."}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-07-27', 'size': 3355473, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-07-16T14:16', 'hasProtocol': True}, {'date': '2021-05-01', 'size': 2113338, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-07-16T14:21', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Phase I, controlled, non-comparative, single-center, open study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2023-05-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-16', 'studyFirstSubmitDate': '2022-03-23', 'resultsFirstSubmitDate': '2025-05-07', 'studyFirstSubmitQcDate': '2022-07-20', 'lastUpdatePostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-16', 'studyFirstPostDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraocular Pressure (IOP) Increment', 'timeFrame': 'Baseline visit (BV), day 1(pre and post pupil dilation); Visit 1 (V1), day 3 +1 (pre and post research product application); Visit 2 (V2), day 8 (pre and post research product application); Final Visit, day 10 (+1)', 'description': 'Safety evaluation through the incidence of subjects presenting an IOP elevation comparing Baseline Visit, Final Visit and before and after (20 minutes) research product administration (V1 and V2). Only right-eye values were analyzed.'}, {'measure': 'Heart Rate Increment', 'timeFrame': 'Baseline visit, day 1(pre and post pupil dilation); Visit 1, day 3 +1 (pre and post research product application); Visit 2, day 8 (pre and post research product application); Final Visit, day 10 (+1)', 'description': 'Safety evaluation through the incidence of subjects presenting an elevation \\> 15 beats per minute 20 minutes after administration, in comparison to baseline value.'}, {'measure': 'Blood Pressure Increment (Systolic)', 'timeFrame': 'Baseline visit, day 1(pre and post pupil dilation); Visit 1, day 3 +1 (pre and post research product application); Visit 2, day 8 (pre and post research product application); Final Visit, day 10 (+1)', 'description': 'Safety evaluation through the incidence of subjects presenting an elevation \\> 15 mmHg in systolic pressure or \\> 10 mmHg in diastolic pressure 20 minutes after administration, in comparison to baseline value.'}, {'measure': 'Incidence of Conjunctival Hyperemia', 'timeFrame': 'Trough Day 10 (+1)', 'description': 'Tolerability evaluation through the incidence of conjunctival hyperemia grades 3 and 4 (according to the Efron scale). A higher score (grades) in this scale translates into worse outcomes. Only right-eye values were analyzed.'}, {'measure': 'Incidence of Pharmacological Mydriasis', 'timeFrame': 'Trough Day 10 (+1)', 'description': 'Incidence of pharmacological mydriasis measured through OPD III scan. If there was a change greater than 2 mm in pupil diameter between the baseline visit and any of the other measurements, pharmacological mydriasis was considered present, also if there was this change between the pre- and post-examination of the investigational product during visits 1 and 2.'}, {'measure': 'Blood Pressure Increment (Diastolic)', 'timeFrame': 'Baseline visit, day 1(pre and post pupil dilation); Visit 1, day 3 +1 (pre and post research product application); Visit 2, day 8 (pre and post research product application); Final Visit, day 10 (+1)', 'description': 'Safety evaluation through the incidence of subjects presenting an elevation \\> 15 mmHg in systolic pressure or \\> 10 mmHg in diastolic pressure 20 minutes after administration, in comparison to baseline value.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hyperemia Eye']}, 'descriptionModule': {'briefSummary': 'Phase I Study to evaluate safety and tolerability of PRO-185 (naphazoline/hypromellose) ophthalmic solution through evaluation of vital signs, ocular signs such as intraocular pressure, hyperemia and mydriasis and adverse events.', 'detailedDescription': 'A total of 22 healthy volunteers will apply PRO-185 ocular solution on both eyes QID (four times per day) for 8 days. The safety variables will include intraocular pressure, heart rate, systolic and diastolic blood pressure. Tolerability variables will include: hyperemia, mydriasis, and expected and unexpected adverse events. The presence of any of these in ≤ 20% will deem PRO-185 as safe and tolerable.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being clinically healthy\n* Having the ability to grant a signed informed consent\n* Being able and willing to comply with the programmed visits, treatment plan and other procedures of this study.\n* Age between 18 and 45 years\n* Women in child-bearing age must assure the continuation (start ≥ 30 days previous to the signing of the ICF) of a hormonal contraceptive method or a intrauterine device (IUD) during the period of the study.\n* Best corrected visual acuity equal of better than 20/30 in both eyes.\n* Vital signs within normal ranges.\n* Intraocular pressure ≥10 and ≤ 21 mmHg\n\nExclusion Criteria:\n\n* Using any kind of topic ophthalmic products\n* Presenting allergies to naphazoline or the history of intolerance to nasal decongestants or ocular vasoconstrictive products.\n* History of diagnosis of suspicion of primary angle closure, primary angle closure or closed angle glaucoma.\n* History of iridotomies or waiting for this procedure to take place.\n* Conjunctival hyperemia grade 3 or 4 according to Efron scale.\n* Ocular surface staining equal or greater to 3 in the SICCA scale, for any eye.\n* Using medications or herbology products, through any route of administration.\n* Pregnant, breastfeeding or women who plan to get pregnant during the period of the study.\n* Previous participation in any clinical study 90 days prior to the inclusion in the present study.\n* Previous participation in this study.\n* Using contact lenses which cannot be suspended during the period of this study.\n* History of any chronic illness, including diabetes and hypertension.\n* Active inflammation or infection at the time of inclusion in this study.\n* Unresolved lesions or traumas at the moment of inclusion in this study.\n* History of any kind of ocular surgery.\n* History of any surgical procedure, non-ophthalmologic, within the previous 3 months to the inclusion in this study.'}, 'identificationModule': {'nctId': 'NCT05470868', 'acronym': 'PRO-185', 'briefTitle': 'Safety and Tolerability of PRO-185', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratorios Sophia S.A de C.V.'}, 'officialTitle': 'Phase I Clinical Study, to Evaluate the Safety and Tolerability of the Ophthalmic Solution PRO-185 When Applied on the Ocular Surface of Healthy Volunteers', 'orgStudyIdInfo': {'id': 'SOPH185-0521/I'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PRO-185', 'description': 'Healthy volunteers will apply one drop of PRO-185 ophthalmic solution (naphazoline / hypromellose) on both eyes, QID (four times per day) for 8 days.', 'interventionNames': ['Drug: Naphazoline / Hypromellose Ophthalmic']}], 'interventions': [{'name': 'Naphazoline / Hypromellose Ophthalmic', 'type': 'DRUG', 'description': 'Naphazoline 0.03% / Hypromellose 0.2%', 'armGroupLabels': ['PRO-185']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44650', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'IIMET Investigación e Innovación en Medicina Translacional', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratorios Sophia S.A de C.V.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}