Phase 1 N=34 Randomized Treatment

Clinical Trial to Evaluate the Safety and Tolerability of Lagricel® Ofteno Multi-dose Ophthalmic Solution

Dry Eye

Bottom Line

View on ClinicalTrials.gov: NCT04081610 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2021

Primary outcome: Primary: Presence of Adverse Events (AEs) — 7; 8 Participants — p=0.409

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: lagricel ofteno multidose (Drug); lagricel ofteno single dose (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Laboratorios Sophia S.A de C.V.
Primary completion: Oct 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Presence of Adverse Events (AEs)	7; 8	0.409
PRIMARY Eye Comfort Index (ECI)	29.98; 27.28; 18.76; 18.01	0.442
SECONDARY Visual Acuity (VA)	0.988; 0.989; 0.969; 0.989	0.904
SECONDARY Epithelial Defects (ED) Fluorescein Stain	30; 34; 2; 2	1.000
SECONDARY Epithelial Defects (ED) Green Lissamine	29; 31; 3; 5	0.713
SECONDARY Conjunctival Hyperemia (CH)	32; 36; 0; 0; 0; 0	1.000
SECONDARY Chemosis	0; 0; 32; 36	—

Summary

Study design: Phase I clinical trial, single-center, controlled, parallel group, open, randomized. Number of subjects: n = 34 evaluable subjects, 17 evaluable subjects per group (both eyes). Estimated duration of the study: 5 months Therapeutic indication: Eye lubricant Use: Dry Eye Objective:To evaluate the safety and tolerability of Lagricel® Ofteno multidose manufactured by Laboratorios Sophia on the ocular surface of clinically healthy subjects. Hypothesis: H0 = Lagricel® Ofteno multidose ophthalmic solution has a safety and tolerability profile similar to Lagricel® Ofteno single dose in healthy subjects. H1 = Lagricel® Ofteno multidose ophthalmic solution has a different safety and tolerability profile than Lagricel® Ofteno single dose in healthy subjects. Main inclusion criteria: Clinically healthy subjects

Eligibility Criteria

Inclusion Criteria

To be clinically healthy
To have the ability to voluntarily grant your signed informed consent
To have the willingness to comply with scheduled visits treatment plan and other study procedures
Women in reproductive age should ensure the continuation (initiated ≥ 30 days prior to the signing of the informed consent) to use a hormonal contraceptive method or intrauterine device during the study period.
To have a better corrected visual acuity of 20/30 or better in both eyes.
To have vital signs in normal parameters.
To have an intraocular pressure between ≥10 and ≤ 21 mmHg.

Exclusion Criteria

To be user of ophthalmic topical products of any kind.
To be user of medicines, or herbal products, by any other route of administration.
In the case of women: being pregnant, breastfeeding or planning to get pregnant in the study period.
Having participated in clinical research studies 90 days prior to inclusion in this study.
Having previously participated in this same study.
To be a user of contact lenses and can not suspend their use during the study.
Having initiated the use of hormonal contraceptives or intrauterine devices, 30 days prior to inclusion in the present study.
To have a history of any chronic degenerative disease.
Having inflammatory or infectious disease, active at the time of admission to the study.
Having injuries or unresolved injuries at the time of admission to the study.
Having a history of any type of eye surgery.
Having undergone surgical procedures, not ophthalmological, in the last 3 months.
To be or to have an immediate family member (for example: spouse, parent / legal guardian, brother or child) who is part of the research site staff or the sponsor who participates directly in this study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04081610). 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.