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Clinical Trial to Evaluate the Safety and Tolerability of Lagricel® Ofteno Multi-dose Ophthalmic Solution
Phase 1 trial testing lagricel ofteno multidose in Dry Eye in 34 participants. Completed in 13 November 2019.
| Lead sponsor | Laboratorios Sophia S.A de C.V. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 34 |
| Start date | 9 September 2019 |
| Primary completion | 23 October 2019 |
| Estimated completion | 13 November 2019 |
| Sites | 1 location across Mexico |
Laboratorios Sophia S.A de C.V. — full company profile →
Adults 18 to 45, any sex, with Dry Eye. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent
| Group | Value | 95% CI |
|---|---|---|
| Lagricel® Ofteno Multidose | 7 | |
| Lagricel® Ofteno Single Dose | 8 |
It is a questionnaire designed to measure the irritation of the ocular surface with Rasch analysis to produce estimates on a linear scale of intervals (ratings: 0-100).The Eye comfort index contains items that focus on the discomfort associated with alterations of the ocular surface.(0: None discomfort, 100: high discomfort).
| Group | Value | 95% CI |
|---|---|---|
| Lagricel® Ofteno Multidose | 29.98 | 20.31 – 39.66 |
| Lagricel® Ofteno Single Dose | 27.28 | 21.38 – 33.18 |
| Group | Value | 95% CI |
|---|---|---|
| Lagricel® Ofteno Multidose | 18.76 | 12.31 – 25.21 |
| Lagricel® Ofteno Single Dose | 18.01 | 11.57 – 24.44 |
Visual acuity (VA) is a test of visual function. It will be evaluated at baseline, without refractive correction with the Snellen chart.Which will be located in a place with adequate lighting, natural or artificial and at a distance of 3meters from the subject to be evaluated. The snellen chart consists of a booklet with 11 lines composed of letters, each line has a different size and a different weighting. the subject is placed at a safe distance and the contralateral eye to which it will be evaluated is covered, then the examiner detects until the line can clearly see the letters given he or
| Group | Value | 95% CI |
|---|---|---|
| Lagricel® Ofteno Multidose | 0.988 | ± 0.05 |
| Lagricel® Ofteno Single Dose | 0.989 | ± 0.05 |
| Group | Value | 95% CI |
|---|---|---|
| Lagricel® Ofteno Multidose | 0.969 | ± 0.09 |
| Lagricel® Ofteno Single Dose | 0.989 | ± 0.05 |
The epithelial defects will be evaluated by means of two stains, green lysine and fluorescein, it is a discrete variable that will be realized by direct observation, it will be staged according to the degrees of the oxford scale that go from 0 to 5 (0-V) according to its severity, where 0 is the normal lower limit and 5 the upper limit of defects.
| Group | Value | 95% CI |
|---|---|---|
| Lagricel® Ofteno Multidose | 30 | |
| Lagricel® Ofteno Single Dose | 34 | |
| Lagricel® Ofteno Multidose | 2 | |
| Lagricel® Ofteno Single Dose | 2 |
The epithelial defects will be evaluated by means of two stains, green lysine and fluorescein, it is a discrete variable that will be realized by direct observation, it will be staged according to the degrees of the oxford scale that go from 0 to 5 (0-V) according to its severity, where 0 is the normal lower limit and 5 the upper limit of defects.
| Group | Value | 95% CI |
|---|---|---|
| Lagricel® Ofteno Multidose | 29 | |
| Lagricel® Ofteno Single Dose | 31 | |
| Lagricel® Ofteno Multidose | 3 | |
| Lagricel® Ofteno Single Dose | 5 |
Conjunctival hyperemia will be evaluated as an ordinal variable, by direct observation and staged using the Efron scale as 0.-Normal / 1.-Very Light/ 2.- Light/ 3.-Mild / 4.-Moderate / 5.- Severe. Based on this scale, the normal and mild stages are considered without pathologies or normal. Mild, moderate and severe are considered pathological.
| Group | Value | 95% CI |
|---|---|---|
| Lagricel® Ofteno Multidose | 32 | |
| Lagricel® Ofteno Single Dose | 36 | |
| Lagricel® Ofteno Multidose | 0 | |
| Lagricel® Ofteno Single Dose | 0 | |
| Lagricel® Ofteno Multidose | 0 | |
| Lagricel® Ofteno Single Dose | 0 | |
| Lagricel® Ofteno Multidose | 0 | |
| Lagricel® Ofteno Single Dose | 0 |
It is defined as conjunctival edema, the result of an inflammatory reaction. It is qualified as present or absent. The evaluator will use a narrow beam of light at 60 ° and will measure if the conjunctiva separates from the sclera by ≥ 1/3 of the total eyelid opening
| Group | Value | 95% CI |
|---|---|---|
| Lagricel® Ofteno Multidose | 0 | |
| Lagricel® Ofteno Single Dose | 0 | |
| Lagricel® Ofteno Multidose | 32 | |
| Lagricel® Ofteno Single Dose | 36 |
Time frame: Adverse events were monitored throughout the study, which lasted about 1 month and 15 days.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Lagricel® Ofteno Multidose | Lagricel® Ofteno Single Dose |
|---|---|---|---|
| burning eyes | Eye disorders | — | — |
| blurred vision | Eye disorders | — | — |
| eye itching | Eye disorders | — | — |
| dysgeusia | Gastrointestinal disorders | — | — |
| foreign body sensation | Eye disorders | — | — |
| Tearing | Eye disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Eye irritation | Eye disorders | — | — |
Data from ClinicalTrials.gov NCT04081610 adverse events section.
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
2 peer-reviewed publications reference this trial (live from Europe PMC):
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