Phase 1
N=24
Safety and Tolerability of the Preservative-free Ophthalmic Solution PRO-122 Compared With Krytantek Ofteno®
Glaucoma
Bottom Line
View on ClinicalTrials.gov: NCT03966365 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: Number of Adverse Events — 28; 31 adverse events — p=0.706
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- PRO-122 (Drug); Krytantek Ofteno® (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Laboratorios Sophia S.A de C.V.
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Adverse Events |
28; 31 | 0.706 |
| PRIMARY Eye Comfort Index |
24.6; 27.0 | 0.622 |
| SECONDARY Number of Eyes With Epithelial Defects by Grade |
20; 16; 2; 4; 0; 4 | 0.081 |
| SECONDARY Visual Ability |
0.949; 0.907 | 0.253 |
| SECONDARY Participants With Conjunctival Hyperemia (CH) by Grade |
10; 9; 0; 3; 1; 0 | 0.031 sig |
| SECONDARY Participants With Chemosis |
0; 0 | — |
Summary
Therapeutic indication: Ocular hypotensive Use: Primary open-angle glaucoma and ocular hypertension.
Objectives: To evaluate the safety and tolerability of the preservative-free formulation PRO-122 manufactured by Sophia Laboratories, S.A. of C.V. on the ocular surface of clinically healthy subjects.
Hypothesis: The ophthalmic solution PRO-122 presents a profile of safety and tolerability similar to Krytantek Ofteno®, in healthy subjects.
Methodology: Phase I clinical trial, controlled, parallel group, double blind, randomized.
Number of patients: n=24 12 subjects per group (both eyes). Main inclusion criteria:Clinically healthy subjects.
Eligibility Criteria
Inclusion Criteria
- - Clinically healthy
- Ability to give your signed informed consent, and show willingness to comply with study procedures and to modify your lifestyle activities (Section 6.2.2)
- Age between 18 to 45 years.
- Indistinct sex.
- Women must ensure a hormonal contraceptive method or intrauterine device during the study period.
- 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.
- Visual ability 20/30 or better in both eyes.
- Vital signs within normal parameters.
- Intraocular pressure ≥10 and ≤ 21 mmHg.
Exclusion Criteria
- Users of topical ophthalmic products of any kind.
- Users of medicines, or herbal products, by any other route of administration, with the exception of hormonal contraceptives in the case of women.
- Women who are pregnant or breastfeeding.
- Participation in clinical research studies 90 days prior to inclusion in the present study.
- Previous participation in this same study.
- Users of contact lenses.
- History of any chronic-degenerative disease.
- Inflammatory or infectious disease, active at the time of study entry.
- Injuries or traumatisms not resolved at the time of admission to the study.
Data sourced from ClinicalTrials.gov (NCT03966365). 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.