Safety and Tolerability of PRO-185
- Registration Number
- NCT05470868
- Lead Sponsor
- Laboratorios Sophia S.A de C.V.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PRO-185 Naphazoline / Hypromellose Ophthalmic Healthy volunteers will apply one drop of PRO-185 ophthalmic solution (naphazoline / hypromellose) on both eyes, QID (four times per day) for 8 days.
- Primary Outcome Measures
Name Time Method Intraocular pressure increment 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) 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 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) 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 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) 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 Trough Day 10 (+1) Tolerability evaluation through the incidence of conjunctival hyperemia grades 3 and 4 (according to the Efron scale).
Incidence of Pharmacological Mydriasis Trough Day 10 (+1) 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
Name Time Method
Trial Locations
- Locations (1)
IIMET Investigación e Innovación en Medicina Translacional
🇲🇽Guadalajara, Jalisco, Mexico