Phase 1
N=30
Safety and Tolerability of PRO-087 Versus Xyel Ofteno® and Systane Ultra®, on the Ocular Surface of Healthy Subjects
Dry Eye Syndromes · Lubricant Allergy · Tear Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03524157 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Goblet Cell Density (GCD) — 282.5; 326.8; 291.5 cells/mm2 — p=0.273
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- PRO-087 (Drug); Systane Ultra (Drug); Xyel Ofteno (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Laboratorios Sophia S.A de C.V.
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Goblet Cell Density (GCD) |
282.5; 326.8; 291.5 | 0.273 |
| SECONDARY Presence of Adverse Events (AEs) |
13; 8; 7 | 0.788 |
| SECONDARY Intraocular Pressure (IOP) |
12.80; 12.55; 12.72 | — |
| SECONDARY Epithelial Defects (ED) |
19; 16; 17; 1; 3; 1 | >0.05 |
| SECONDARY Breakup Time (BUT) |
8.8; 7.3; 9.6 | 0.008 sig |
| SECONDARY Conjunctival Hyperemia (CH) |
19; 16; 17; 1; 3; 1 | >0.05 |
| SECONDARY Chemosis |
0; 0; 0 | — |
| SECONDARY Ocular Burning (OB) |
4; 4; 0 | >0.05 |
| SECONDARY Foreign Body Sensation (FBS) |
20; 16; 16; 0; 4; 2 | >0.05 |
| SECONDARY Ocular Pruritus (P) |
18; 16; 16; 2; 4; 2 | >0.05 |
Summary
Phase I clinical study, to evaluate the safety and tolerability of the preservative-free ophthalmic solution PRO-087 versus Xyel Ofteno® and Systane Ultra®, on the ocular surface of ophthalmological and clinically healthy subjects.
Objective: To evaluate the safety and tolerability of the preservative-free formulation PRO-087 manufactured by Laboratorios Sophia S.A. of C.V. on the ocular surface of clinically healthy subjects.
Hypothesis:
The ophthalmic solution PRO-087 presents a profile of safety and tolerability similar to comparators in healthy subjects
Methodology:
Phase I clinical trial, controlled, of parallel groups, double blind, randomized, exploratory.
Eligibility Criteria
Inclusion Criteria
- Systemically and ophthalmologically healthy subjects
- Signed informed consent.
- Age between 18 to 40 years.
- Both genders
- Blood tests [complete blood count (BHC), three element blood chemistry (QS) and liver function tests (PFH)] within normal parameters
- Visual capacity 20/30 or better
Exclusion 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.
- Women who are pregnant or breastfeeding.
- Women without a history of hysterectomy, oophorectomy or hysterectomy, who do not ensure a hormonal contraceptive method or intrauterine device during the study period.
- Subjects with participation in clinical research studies 90 days prior to inclusion in the present study.
- Diagnosis of liver disease or triple 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 quantity and frequency)
- Positive alcoholism (specified as the consumption of alcoholic beverages, regardless of quantity and frequency, during the study intervention period).
- Users of contact lenses.
Data sourced from ClinicalTrials.gov (NCT03524157). 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.