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
About this trial
This is an interventional treatment trial for Hyperemia Eye
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.
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
NCT ID
NCT05470868
First Posted
March 23, 2022
Last Updated
December 26, 2022
Sponsor
Laboratorios Sophia S.A de C.V.
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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Safety and Tolerability of PRO-185
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