Clinical trial NCT05470868: Safety and Tolerability of 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hyperemia Eye
Lead sponsor: Laboratorios Sophia S.A de C.V.
Sponsor class: INDUSTRY
First posted: 2022-07-22
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Phase I, controlled, non-comparative, single-center, open study.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Intraocular pressure 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)
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)
measure: Blood pressure 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)
measure: Incidence of Conjunctival Hyperemia
timeFrame: Trough Day 10 (+1)
measure: Incidence of Pharmacological Mydriasis
timeFrame: Trough Day 10 (+1)
Secondary outcomes:
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: IIMET Investigación e Innovación en Medicina Translacional
state: Jalisco
Study officials:
References: