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Safety and Tolerability of PRO-185 (PRO-185)

Primary Purpose

Hyperemia Eye

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Naphazoline / Hypromellose Ophthalmic
Sponsored by
Laboratorios Sophia S.A de C.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperemia Eye

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Being clinically healthy
  • Having the ability to grant a signed informed consent
  • Being able and willing to comply with the programmed visits, treatment plan and other procedures of this study.
  • Age between 18 and 45 years
  • 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.
  • Best corrected visual acuity equal of better than 20/30 in both eyes.
  • Vital signs within normal ranges.
  • Intraocular pressure ≥10 and ≤ 21 mmHg

Exclusion Criteria:

  • Using any kind of topic ophthalmic products
  • Presenting allergies to naphazoline or the history of intolerance to nasal decongestants or ocular vasoconstrictive products.
  • History of diagnosis of suspicion of primary angle closure, primary angle closure or closed angle glaucoma.
  • History of iridotomies or waiting for this procedure to take place.
  • Conjunctival hyperemia grade 3 or 4 according to Efron scale.
  • Ocular surface staining equal or greater to 3 in the SICCA scale, for any eye.
  • Using medications or herbology products, through any route of administration.
  • Pregnant, breastfeeding or women who plan to get pregnant during the period of the study.
  • Previous participation in any clinical study 90 days prior to the inclusion in the present study.
  • Previous participation in this study.
  • Using contact lenses which cannot be suspended during the period of this study.
  • History of any chronic illness, including diabetes and hypertension.
  • Active inflammation or infection at the time of inclusion in this study.
  • Unresolved lesions or traumas at the moment of inclusion in this study.
  • History of any kind of ocular surgery.
  • History of any surgical procedure, non-ophthalmologic, within the previous 3 months to the inclusion in this study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    PRO-185

    Arm 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.

    Outcomes

    Primary Outcome Measures

    Intraocular pressure increment
    Safety evaluation through the incidence of subjects presenting an elevation > 5 mmHg in intraocular pressure 20 minutes after administration, in comparison to baseline value.
    Heart rate increment
    Safety evaluation through the incidence of subjects presenting an elevation > 15 beats per minute 20 minutes after administration, in comparison to baseline value.
    Blood pressure increment
    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.
    Incidence of Conjunctival Hyperemia
    Tolerability evaluation through the incidence of conjunctival hyperemia grades 3 and 4 (according to the Efron scale).
    Incidence of Pharmacological Mydriasis
    Tolerability evaluation through the incidence of pharmacological mydriasis measured through OPD III scan (considered as a difference > 2 mm compared to the baseline value).

    Secondary Outcome Measures

    Full Information

    First Posted
    March 23, 2022
    Last Updated
    December 26, 2022
    Sponsor
    Laboratorios Sophia S.A de C.V.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05470868
    Brief Title
    Safety and Tolerability of PRO-185
    Acronym
    PRO-185
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 1, 2023 (Anticipated)
    Primary Completion Date
    March 31, 2023 (Anticipated)
    Study Completion Date
    March 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Laboratorios Sophia S.A de C.V.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hyperemia Eye

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Model Description
    Phase I, controlled, non-comparative, single-center, open study.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    22 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PRO-185
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Drug
    Intervention Name(s)
    Naphazoline / Hypromellose Ophthalmic
    Intervention Description
    Naphazoline 0.03% / Hypromellose 0.2%
    Primary Outcome Measure Information:
    Title
    Intraocular pressure increment
    Description
    Safety evaluation through the incidence of subjects presenting an elevation > 5 mmHg in intraocular pressure 20 minutes after administration, in comparison to baseline value.
    Time Frame
    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)
    Title
    Heart rate increment
    Description
    Safety evaluation through the incidence of subjects presenting an elevation > 15 beats per minute 20 minutes after administration, in comparison to baseline value.
    Time Frame
    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)
    Title
    Blood pressure increment
    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.
    Time Frame
    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)
    Title
    Incidence of Conjunctival Hyperemia
    Description
    Tolerability evaluation through the incidence of conjunctival hyperemia grades 3 and 4 (according to the Efron scale).
    Time Frame
    Trough Day 10 (+1)
    Title
    Incidence of Pharmacological Mydriasis
    Description
    Tolerability evaluation through the incidence of pharmacological mydriasis measured through OPD III scan (considered as a difference > 2 mm compared to the baseline value).
    Time Frame
    Trough Day 10 (+1)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Being clinically healthy Having the ability to grant a signed informed consent Being able and willing to comply with the programmed visits, treatment plan and other procedures of this study. Age between 18 and 45 years 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. Best corrected visual acuity equal of better than 20/30 in both eyes. Vital signs within normal ranges. Intraocular pressure ≥10 and ≤ 21 mmHg Exclusion Criteria: Using any kind of topic ophthalmic products Presenting allergies to naphazoline or the history of intolerance to nasal decongestants or ocular vasoconstrictive products. History of diagnosis of suspicion of primary angle closure, primary angle closure or closed angle glaucoma. History of iridotomies or waiting for this procedure to take place. Conjunctival hyperemia grade 3 or 4 according to Efron scale. Ocular surface staining equal or greater to 3 in the SICCA scale, for any eye. Using medications or herbology products, through any route of administration. Pregnant, breastfeeding or women who plan to get pregnant during the period of the study. Previous participation in any clinical study 90 days prior to the inclusion in the present study. Previous participation in this study. Using contact lenses which cannot be suspended during the period of this study. History of any chronic illness, including diabetes and hypertension. Active inflammation or infection at the time of inclusion in this study. Unresolved lesions or traumas at the moment of inclusion in this study. History of any kind of ocular surgery. History of any surgical procedure, non-ophthalmologic, within the previous 3 months to the inclusion in this study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alejandra Sanchez-Rios, MD
    Phone
    +52 3330014200
    Ext
    1190
    Email
    alejandra.sanchez@sophia.com.mx

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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