Phase 1 N=24 Randomized Double-blind Treatment

Safety and Tolerability of the Ophthalmic Solution PRO-179 Compared With Travatan®

Glaucoma

Bottom Line

View on ClinicalTrials.gov: NCT03965052 ↗

Enrolled (actual)

Serious AEs

4.2%

Results posted

Dec 2019

Primary outcome: Primary: Number of Participants With Adverse Events — 10; 11 Participants — p=1.000

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: PRO 179 (Drug); Travatan 0.004 % Ophthalmic Solution (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Laboratorios Sophia S.A de C.V.
Primary completion: Jul 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Adverse Events	10; 11	1.000
PRIMARY Eye Comfort Index	26.61; 28.97	—
SECONDARY Number of Eyes With Epithelial Defects by Grade	22; 23; 0; 1; 0; 0	1.000
SECONDARY Visual Ability	0.0; 0.0	1.000
SECONDARY Percentage of Eyes With Conjunctival Hyperemia (CH) by Grade	14; 16; 2; 2; 6; 6	0.977
SECONDARY Number of Eyes of Chemosis	0; 0	—

Summary

Phase I clinical study, to evaluate the safety and tolerability of the ophthalmic solution PRO-179 compared with Travatan®, on the ocular surface of clinically healthy subjects. Goals: To evaluate the safety and tolerability of the formulation PRO-179 manufactured by Sophia Laboratories S.A. of C.V. on the ocular surface of clinically healthy subjects. Hypothesis:The ophthalmic solution PRO-179 presents a profile of safety and tolerability similar to Travatan® in healthy subjects. Methodology: Clinical trial Phase I, controlled, of parallel groups, double blind, with randomization.

Eligibility Criteria

Inclusion Criteria

Be clinically healthy.
Have the ability to give their signed informed consent and show willingness to comply with the study procedures
Have an age between 18 to 45 years.
Indistinct sex.
Women should ensure the continued use of a hormonal contraceptive method or intrauterine device (IUD) during the study period.
Present blood tests: within normal parameters or with a range of ± 20% as long as the subject is clinically healthy.

Blood count (BH): Hemoglobin, erythrocytes, hematocrit, total leukocytes, platelets, mean corpuscular volume and mean corpuscular hemoglobin.

Blood chemistry of three elements (QS): Glucose, urea and creatinine.
Liver function tests (PFH): Aspartate Aminotransferase and Alanine Aminotransferase, total bilirubin, direct and indirect.
Present visual ability 20/30 or better in both eyes.
Present vital signs within normal parameters.
Present intraocular pressure ≥10 and ≤ 21 mmHg.

Exclusion Criteria

Be a user of topical ophthalmic products of any kind.
Be a user of medicines, or herbal products, by any other route of administration, with the exception of hormonal contraceptives in the case of women.
In case of being a woman, being pregnant or breastfeeding.
Have participated in clinical research studies 90 days prior to inclusion in the present study.
Have previously participated in this same study.
Be a user of contact lenses and can not suspend their use during the study.
That they can not follow the lifestyle considerations described in section 6.2.2
Having started the use of hormonal contraceptives or IUD, 30 days prior to inclusion in the present study.
Having a history of any chronic-degenerative disease.
Present inflammatory or infectious disease, active at the time of admission to the study.
Present injuries or unresolved traumas at the time of entering the study.
Having the antecedent of any type of eye surgery.
Having undergone surgical procedures, not ophthalmological, in the last 3 months.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03965052). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.