Safety and Tolerability of the PRO-174 Versus Sophixín Ofteno®, on the Ocular Surface of Healthy Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03519516
• Date of registration: 26/04/2018
• Prospective Registration: No
• Primary sponsor: Laboratorios Sophia S.A de C.V.
• Public title: Safety and Tolerability of the PRO-174 Versus Sophixín Ofteno®, on the Ocular Surface of Healthy Subjects PRO-174/I
• Scientific title: Phase I Clinical Trial, to Evaluate the Safety and Tolerability of the Ophthalmic Solution PRO-174 Versus Sophixín Ofteno®, Elaborated by Laboratorios Sophia on the Ocular Surface of Ophthalmological and Clinically Healthy Subjects
• Date of first enrolment: January 25, 2018
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03519516
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

Mexico

Contacts

• Name: Leopoldo Baiza Durán, MD
• Affiliation: Laboratorios Sophia S.A de C.V.

Key inclusion & exclusion criteria

Inclusion Criteria:

- Signed informed consent.

- Systemically and ophthalmologically healthy subjects evaluated during the clinical
history.

- Age between 18 to 45 years.

- Both genders.

- Blood tests (complete blood count, blood chemistry of three elements and liver
function tests) within normal parameters specified by the reference laboratory with a
lower and upper margin of 10%.

- Vital signs within normal parameters. (Vital signs at rest: blood pressure = 139/89
mmHg, heart rate 60 -100 beats per minute and respiratory rate of 12-24 breaths per
minute).

- Visual capacity 20/30 or better, in both eyes.

- Intraocular pressure =11 and = 21 mmHg.

Exclusion Criteria:

General criteria

- Subjects with a history of hypersensitivity to any of the components of the research
products.

- Subject users of topical ophthalmic medications of any pharmacological group.

- Subject users of medication by any other route of administration.

- Pregnant or lactating women.

- Women of childbearing age, who do not ensure a hormonal contraceptive method or
intrauterine device during the study period or without a history of bilateral tubal
obstruction, oophorectomy or hysterectomy; as fertile age we understand women who have
not had their menopause, defined as 12 months since the last menstruation in women
over 40 years.

- Subjects with participation in clinical research studies 90 days prior to inclusion in
the present study.

- Diagnosis of liver disease or elevation to three times the normal upper value of any
of the following liver enzymes: aspartate transferase (AST), alanine transferase (ALT)
or bilirubin.

- Inability to attend or answer the evaluations made in each of the visits.

- Positive smoking (specified as cigarette consumption regardless of amount and
frequency)

- Positive alcoholism (specified as the consumption of alcoholic beverages, regardless
of quantity and frequency, during the study intervention period).

- Contact lens users.

- An occlusive iridocorneal angle, defined as a trabecular mesh visible at less than 90
° from the angular circumference to gonioscopy.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: All

Health Condition(s) or Problem(s) studied

Conjunctivitis, Bacterial

Conjunctivitis

Intervention(s)

Drug: Sophixín Ofteno®

Drug: PRO-174

Primary Outcome(s)

Number of Adverse Events (EAS) [Time Frame: during the 12 days of evaluation, including the safety call (day 12).]

Ocular Burning (OB) [Time Frame: will be evaluated at the end of the treatment at the final visit (day 7)]

Secondary Outcome(s)

Percentage of Eyes With Conjunctival Hyperemia (CH) by Grade [Time Frame: will be evaluated at the end of the treatment at the final visit (day 7)]

Number of Eyes With Epithelial Defects (ED) by Grade [Time Frame: will be evaluated at the end of the treatment at the final visit (day 7)]

Number of Eyes With Foreign Body Sensation (FBS) by Grade [Time Frame: will be evaluated at the end of the treatment at the final visit (day 7)]

Number of Eyes With Ocular Pruritus (P) by Grade [Time Frame: will be evaluated at the end of the treatment at the final visit (day 7)]

Number of Eyes of Chemosis [Time Frame: will be evaluated at the end of the treatment at the final visit (day 7)]

Visual Capacity [Time Frame: will be evaluated at the end of the treatment at the final visit (day 7)]

Intraocular Pressure (IOP) [Time Frame: will be evaluated at the end of the treatment at the final visit (day 7)]

Breakup Time (BUT) [Time Frame: will be evaluated at the end of the treatment at the final visit (day 7)]

Secondary ID(s)

SOPH174-0816/I

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 25/10/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03519516