Clinical trial NCT04693429: Clinical Study for the Evaluation of Safety and Tolerability of PRO-172 Ophthalmic Solution+
Official title: Phase I Clinical Study for the Evaluation of Safety and Tolerability of PRO-172 Ophthalmic Solution, Manufactured by Laboratorios Sophia, S.A. de C.V., When Applied on the Ocular Surface of Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Safety
Tolerability
Ocular Surface
Ocular Comfort
Lead sponsor: Laboratorios Sophia S.A de C.V.
Sponsor class: INDUSTRY
First posted: 2021-01-05
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: Controlled, single center, non comparative
Primary purpose: OTHER

Brief summary: Clinical phase I, controlled, non comparative, open, single center study evaluating the safety and tolerability of ophthalmic solution PRO-172 when applied on the ocular surface of healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Clinically healthy volunteers
* Being capable of voluntarily grant a signed informed consent.
* Being willing and able to meet the requirements of the study such as attending programmed visits, treatment plan and other study procedures.
* Being between 18 and 45 years old.
* Women in child-bearing age must assure the continuation (start ≥ 30 days prior to informed consent signing) of a hormonal contraceptive method of intrauterine device (IUD) during the study.
* Having a best corrected visual acuity equal or better than 20/30 in both eyes.
* Showing normal vital signs.
* Having an intraocular pressure between 10 and 21 mmHg.

Exclusion Criteria:

* Using any kind of ophthalmic topical product.
* Using drugs or herbal products, through any administration route.
* For women: pregnancy, breastfeeding or planning to become pregnant during the time of the study.
* Having participated in clinical trials 90 days prior to inclusion in this study.
* Having participated previously in this study.
* Using contact lenses and not being able to suspend such use during the period of the study.
* Being unable to follow the lifestyle modification considerations required for the study.
* Having started the use of hormonal contraceptives of IUD within 30 days previous of inclusion in this study.
* Suffering any chronic degenerative diseases.
* Suffering active inflammatory of infectious disease when entering this study.
* Suffering unresolved lesions or traumas when entering this study.
* Having a previous history of any kind of ocular surgery.
* Having a previous history of any surgical procedure, non ophthalmological, within the last 3 months.

Primary outcomes:
measure: Incidence of related non expected adverse events
timeFrame: Day 10
measure: Ocular Comfort Index
timeFrame: Day 8
Secondary outcomes:
measure: Changes in Best Corrected Visual Acuity (BCVA)
timeFrame: Day 8
measure: Conjunctival and corneal staining with lissamine green
timeFrame: Day 8
measure: Conjunctival and corneal staining with fluorescein
timeFrame: Day 8
measure: Conjunctival hyperemia
timeFrame: Day 8
measure: Chemosis incidence
timeFrame: Day 8
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Unidad Clínica de Bioequivalencia, S. de R.L. de C.V.
state: Jalisco
Study officials:
References: