Trial Outcomes & Findings for Clinical Trial to Evaluate the Safety and Tolerability of Lagricel® Ofteno Multi-dose Ophthalmic Solution (NCT NCT04081610)
NCT ID: NCT04081610
Last Updated: 2021-05-03
Results Overview
the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent
COMPLETED
PHASE1
34 participants
during the 10 days of evaluation, including the safety call (day 11).
2021-05-03
Participant Flow
Unit of analysis: Eyes
Participant milestones
| Measure |
Lagricel® Ofteno Multidose
Lagricel® Ofteno Multidose 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia
lagricel ofteno multidose: - Dosage: 1 drop 4 times a day per 7 days, both eyes
\- Route of administration: Ophthalmic
|
Lagricel® Ofteno Single Dose
Lagricel® Ofteno single dose. 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia
lagricel ofteno single dose: - Dosage: 1 drop 4 times a day per 7 days, both eyes
\- Route of administration: Ophthalmic
|
|---|---|---|
|
Overall Study
STARTED
|
16 32
|
18 36
|
|
Overall Study
COMPLETED
|
16 32
|
18 36
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Lagricel® Ofteno Multidose
n=16 Participants
Lagricel® Ofteno Multidose 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia
lagricel ofteno multidose: - Dosage: 1 drop 4 times a day per 7 days, both eyes
\- Route of administration: Ophthalmic
|
Lagricel® Ofteno Single Dose
n=18 Participants
Lagricel® Ofteno single dose. 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia
lagricel ofteno single dose: - Dosage: 1 drop 4 times a day per 7 days, both eyes
\- Route of administration: Ophthalmic
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.8 years
STANDARD_DEVIATION 6.6 • n=16 Participants
|
29.7 years
STANDARD_DEVIATION 7.9 • n=18 Participants
|
29.0 years
STANDARD_DEVIATION 7.33 • n=34 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=16 Participants
|
9 Participants
n=18 Participants
|
21 Participants
n=34 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=16 Participants
|
9 Participants
n=18 Participants
|
13 Participants
n=34 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Mexico
|
16 participants
n=16 Participants
|
18 participants
n=18 Participants
|
34 participants
n=34 Participants
|
PRIMARY outcome
Timeframe: during the 10 days of evaluation, including the safety call (day 11).the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent
Outcome measures
| Measure |
Lagricel® Ofteno Multidose
n=16 Participants
Lagricel® Ofteno Multidose 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia
lagricel ofteno multidose: - Dosage: 1 drop 4 times a day per 7 days, both eyes
\- Route of administration: Ophthalmic
|
Lagricel® Ofteno Single Dose
n=18 Participants
Lagricel® Ofteno single dose. 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia
lagricel ofteno single dose: - Dosage: 1 drop 4 times a day per 7 days, both eyes
\- Route of administration: Ophthalmic
|
|---|---|---|
|
Presence of Adverse Events (AEs)
|
7 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: will be evaluated at the end of the treatment (day 8, final visit)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).
Outcome measures
| Measure |
Lagricel® Ofteno Multidose
n=16 Participants
Lagricel® Ofteno Multidose 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia
lagricel ofteno multidose: - Dosage: 1 drop 4 times a day per 7 days, both eyes
\- Route of administration: Ophthalmic
|
Lagricel® Ofteno Single Dose
n=18 Participants
Lagricel® Ofteno single dose. 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia
lagricel ofteno single dose: - Dosage: 1 drop 4 times a day per 7 days, both eyes
\- Route of administration: Ophthalmic
|
|---|---|---|
|
Eye Comfort Index (ECI)
Final ECI
|
18.76 score on a scale
Interval 12.31 to 25.21
|
18.01 score on a scale
Interval 11.57 to 24.44
|
|
Eye Comfort Index (ECI)
Inicial ECI
|
29.98 score on a scale
Interval 20.31 to 39.66
|
27.28 score on a scale
Interval 21.38 to 33.18
|
SECONDARY outcome
Timeframe: will be evaluated at the end of the treatment (day 8, final visit)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 she a score, the normal score for a VA is 20/20.
Outcome measures
| Measure |
Lagricel® Ofteno Multidose
n=16 Participants
Lagricel® Ofteno Multidose 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia
lagricel ofteno multidose: - Dosage: 1 drop 4 times a day per 7 days, both eyes
\- Route of administration: Ophthalmic
|
Lagricel® Ofteno Single Dose
n=18 Participants
Lagricel® Ofteno single dose. 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia
lagricel ofteno single dose: - Dosage: 1 drop 4 times a day per 7 days, both eyes
\- Route of administration: Ophthalmic
|
|---|---|---|
|
Visual Acuity (VA)
Final VA
|
0.988 LogMAR
Standard Deviation 0.05
|
0.989 LogMAR
Standard Deviation 0.05
|
|
Visual Acuity (VA)
Initial VA
|
0.969 LogMAR
Standard Deviation 0.09
|
0.989 LogMAR
Standard Deviation 0.05
|
SECONDARY outcome
Timeframe: will be evaluated at the end of the treatment (day 8, final visit)Population: Initial Fluorescein Staining Grade 0 (Lagricel® Ofteno Multidose n=22; Lagricel® Ofteno Single dose n=26) Initial Fluorescein Staining Grade 1 (Lagricel® Ofteno Multidose n=8; Lagricel® Ofteno Single dose n=8) Initial Fluorescein Staining Grade 2 (Lagricel® Ofteno Multidose n=2; Lagricel® Ofteno Single dose n=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.
Outcome measures
| Measure |
Lagricel® Ofteno Multidose
n=32 Eyes
Lagricel® Ofteno Multidose 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia
lagricel ofteno multidose: - Dosage: 1 drop 4 times a day per 7 days, both eyes
\- Route of administration: Ophthalmic
|
Lagricel® Ofteno Single Dose
n=36 Eyes
Lagricel® Ofteno single dose. 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia
lagricel ofteno single dose: - Dosage: 1 drop 4 times a day per 7 days, both eyes
\- Route of administration: Ophthalmic
|
|---|---|---|
|
Epithelial Defects (ED) Fluorescein Stain
Final Fluorescein Staining Grade 0
|
30 Eyes
|
34 Eyes
|
|
Epithelial Defects (ED) Fluorescein Stain
Final Fluorescein Staining Grade 1
|
2 Eyes
|
2 Eyes
|
SECONDARY outcome
Timeframe: will be evaluated at the end of the treatment (day 8, final visit)Population: Initial Lissamine Green Staining Grade 0 (Lagricel® Ofteno Multidose n=24; Lagricel® Ofteno Single dose n= 23 Initial Lissamine Green Staining Grade 1 (Lagricel® Ofteno Multidose n=6; Lagricel® Ofteno Single dose n= 11 Initial Lissamine Green Staining Grade 2 (Lagricel® Ofteno Multidose n=1; Lagricel® Ofteno Single dose n= 2 Initial Lissamine Green Staining Grade 3 (Lagricel® Ofteno Multidose n=1; Lagricel® Ofteno Single dose n= 0)
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.
Outcome measures
| Measure |
Lagricel® Ofteno Multidose
n=32 Eyes
Lagricel® Ofteno Multidose 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia
lagricel ofteno multidose: - Dosage: 1 drop 4 times a day per 7 days, both eyes
\- Route of administration: Ophthalmic
|
Lagricel® Ofteno Single Dose
n=36 Eyes
Lagricel® Ofteno single dose. 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia
lagricel ofteno single dose: - Dosage: 1 drop 4 times a day per 7 days, both eyes
\- Route of administration: Ophthalmic
|
|---|---|---|
|
Epithelial Defects (ED) Green Lissamine
Final Lissamine Green Staining Grade 0
|
29 Eyes
|
31 Eyes
|
|
Epithelial Defects (ED) Green Lissamine
Final Lissamine Green Staining Grade 1
|
3 Eyes
|
5 Eyes
|
SECONDARY outcome
Timeframe: will be evaluated at the end of the treatment (day 8, final visit)Population: Initial conjunctival hyperemia (Lagricel® Ofteno Multidose n=26; Lagricel® Ofteno Single dose n=28)
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.
Outcome measures
| Measure |
Lagricel® Ofteno Multidose
n=32 Eyes
Lagricel® Ofteno Multidose 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia
lagricel ofteno multidose: - Dosage: 1 drop 4 times a day per 7 days, both eyes
\- Route of administration: Ophthalmic
|
Lagricel® Ofteno Single Dose
n=36 Eyes
Lagricel® Ofteno single dose. 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia
lagricel ofteno single dose: - Dosage: 1 drop 4 times a day per 7 days, both eyes
\- Route of administration: Ophthalmic
|
|---|---|---|
|
Conjunctival Hyperemia (CH)
Hyperemia grade 0 (Normal)
|
32 Eyes
|
36 Eyes
|
|
Conjunctival Hyperemia (CH)
Hyperemia grade 1 (Very Light)
|
0 Eyes
|
0 Eyes
|
|
Conjunctival Hyperemia (CH)
Hyperemia grade 2 (Light)
|
0 Eyes
|
0 Eyes
|
|
Conjunctival Hyperemia (CH)
Hyperemia grade 3 (Mild)
|
0 Eyes
|
0 Eyes
|
|
Conjunctival Hyperemia (CH)
Hyperemia grade 4 (Moderate)
|
0 Eyes
|
0 Eyes
|
|
Conjunctival Hyperemia (CH)
Hyperemia grade 5 (Severe)
|
0 Eyes
|
0 Eyes
|
SECONDARY outcome
Timeframe: will be evaluated at the end of the treatment (day 8, final visit)Population: Initial Chemosis (Lagricel® Ofteno Multidose, n=0; Lagricel® Ofteno Single dose, n=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
Outcome measures
| Measure |
Lagricel® Ofteno Multidose
n=32 Eyes
Lagricel® Ofteno Multidose 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia
lagricel ofteno multidose: - Dosage: 1 drop 4 times a day per 7 days, both eyes
\- Route of administration: Ophthalmic
|
Lagricel® Ofteno Single Dose
n=36 Eyes
Lagricel® Ofteno single dose. 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia
lagricel ofteno single dose: - Dosage: 1 drop 4 times a day per 7 days, both eyes
\- Route of administration: Ophthalmic
|
|---|---|---|
|
Chemosis
Final chemosis present
|
0 Eyes
|
0 Eyes
|
|
Chemosis
Final chemosis absent
|
32 Eyes
|
36 Eyes
|
Adverse Events
Lagricel® Ofteno Multidose
Lagricel® Ofteno Single Dose
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lagricel® Ofteno Multidose
n=16 participants at risk
Lagricel® Ofteno Multidose 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia
lagricel ofteno multidose: - Dosage: 1 drop 4 times a day per 7 days, both eyes
\- Route of administration: Ophthalmic
|
Lagricel® Ofteno Single Dose
n=18 participants at risk
Lagricel® Ofteno single dose. 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia
lagricel ofteno single dose: - Dosage: 1 drop 4 times a day per 7 days, both eyes
\- Route of administration: Ophthalmic
|
|---|---|---|
|
Eye disorders
blurred vision
|
12.5%
2/16 • Number of events 2 • Adverse events were monitored throughout the study, which lasted about 1 month and 15 days.
|
16.7%
3/18 • Number of events 3 • Adverse events were monitored throughout the study, which lasted about 1 month and 15 days.
|
|
Eye disorders
burning eyes
|
25.0%
4/16 • Number of events 4 • Adverse events were monitored throughout the study, which lasted about 1 month and 15 days.
|
27.8%
5/18 • Number of events 5 • Adverse events were monitored throughout the study, which lasted about 1 month and 15 days.
|
|
Eye disorders
eye itching
|
12.5%
2/16 • Number of events 2 • Adverse events were monitored throughout the study, which lasted about 1 month and 15 days.
|
5.6%
1/18 • Number of events 1 • Adverse events were monitored throughout the study, which lasted about 1 month and 15 days.
|
|
Gastrointestinal disorders
dysgeusia
|
6.2%
1/16 • Number of events 1 • Adverse events were monitored throughout the study, which lasted about 1 month and 15 days.
|
11.1%
2/18 • Number of events 2 • Adverse events were monitored throughout the study, which lasted about 1 month and 15 days.
|
|
Eye disorders
Tearing
|
6.2%
1/16 • Number of events 1 • Adverse events were monitored throughout the study, which lasted about 1 month and 15 days.
|
0.00%
0/18 • Adverse events were monitored throughout the study, which lasted about 1 month and 15 days.
|
|
Nervous system disorders
Headache
|
6.2%
1/16 • Number of events 1 • Adverse events were monitored throughout the study, which lasted about 1 month and 15 days.
|
5.6%
1/18 • Number of events 1 • Adverse events were monitored throughout the study, which lasted about 1 month and 15 days.
|
|
Eye disorders
foreign body sensation
|
0.00%
0/16 • Adverse events were monitored throughout the study, which lasted about 1 month and 15 days.
|
11.1%
2/18 • Number of events 2 • Adverse events were monitored throughout the study, which lasted about 1 month and 15 days.
|
|
Eye disorders
Eye irritation
|
0.00%
0/16 • Adverse events were monitored throughout the study, which lasted about 1 month and 15 days.
|
5.6%
1/18 • Number of events 1 • Adverse events were monitored throughout the study, which lasted about 1 month and 15 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Only the sponsor has the decision to disseminate or publish the information obtained from the investigation and the PIs involved must submit a formal request to the sponsor if they are willing to disseminate or publish such information, they may only publish them if they have the written authorization of the sponsor (Laboratoios Sophia S.A. de C.V.).
- Publication restrictions are in place
Restriction type: OTHER