Dry EyePhase 1PRO-037NCT04081610
Clinical Trial to Evaluate the Safety and Tolerability of Lagricel® Ofteno Multi-dose Ophthalmic Solution
A Phase 1 study testing lagricel ofteno multidose and lagricel ofteno single dose in people with Dry Eye, run by Laboratorios Sophia S.A de C.V. at 1 site in Mexico.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- lagricel ofteno multidose and lagricel ofteno single dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteMexico
- Study dates
- 9 Sep 2019to 13 Nov 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Biomedical research G & LS de RL de CV
Guadalajara, Jalisco, 45070
About this study
Official title: Phase I Clinical Trial to Evaluate the Safety and Tolerability of Lagricel® Ofteno Multi-dose Ophthalmic Solution Compared to Lagricel® Ofteno Single Dose on the Ocular Surface of Clinically Healthy Subjects
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).
Read more
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
- Conditions
- Dry Eye
- Being tested
- lagricel ofteno multidose, lagricel ofteno single dose
- Keywords
- Dry eye, eye lubricant, sodium hyaluronate
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lagricel ofteno multidoseDrug
Also called sodium hyaluronate 0.4%
- Dosage: 1 drop 4 times a day per 7 days, both eyes
- Route of administration: Ophthalmic
lagricel ofteno single doseDrug
Also called sodium hyaluronate 0.4%
- Dosage: 1 drop 4 times a day per 7 days, both eyes
- Route of administration: Ophthalmic
| Study group | Role | What they receive |
|---|---|---|
| Lagricel® Ofteno Multidose | Experimental | Lagricel® Ofteno Multidose 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia Receives: Drug: lagricel ofteno multidose |
| Lagricel® Ofteno Single dose | Active comparator | Lagricel® Ofteno single dose. 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia Receives: Drug: lagricel ofteno single dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Adverse Events (AEs)
the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent
Measured: during the 10 days of evaluation, including the safety call (day 11).
Eye Comfort Index (ECI)
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).
Measured: will be evaluated at the end of the treatment (day 8, final visit)
Secondary outcomes (5)
Visual Acuity (VA)
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.
Measured: will be evaluated at the end of the treatment (day 8, final visit)
Epithelial Defects (ED) Fluorescein Stain
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.
Measured: will be evaluated at the end of the treatment (day 8, final visit)
Epithelial Defects (ED) Green Lissamine
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.
Measured: will be evaluated at the end of the treatment (day 8, final visit)
Conjunctival Hyperemia (CH)
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.
Measured: will be evaluated at the end of the treatment (day 8, final visit)
Chemosis
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
Measured: will be evaluated at the end of the treatment (day 8, final visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start9 Sep 2019
- Primary completion23 Oct 2019
- Study completion13 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single-center, controlled, parallel group, open, randomized
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Sophia S.A de C.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leopoldo Baiza Durán, MD, Study director, Laboratorios Sophia S.A de C.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04081610
- Sponsor's protocol ID
- SOPH037-0119/I
- Acronym
- PRO-037
- Status last verified
- Mar 2021
- First submitted
- 4 Sep 2019
- Last updated
- 3 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Laboratorios Sophia, S.A. de C.V., serving as the sponsor of the study, assumes full responsibility for its function and retains exclusive ownership rights over the results of the study. The principal investigator undertakes not to publish or communicate data collected from the study, unless there is prior written agreement of Laboratorios Sophia, S.A. de C.V.
Publications
Munoz-Villegas P, Navarro-Sanchez AA, Sanchez-Rios A, Olvera-Montano O, Baiza-Duran LM. Reexamining Ophthalmic Drugs, Safety and Tolerability in Phase 1 Clinical Trials. Ther Clin Risk Manag. 2021 Oct 21;17:1123-1134. doi: 10.2147/TCRM.S331294. eCollection 2021.
PubMed 34707360
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial to Evaluate the Safety and Tolerability of Lagricel® Ofteno Multi-dose Ophthalmic Solution Compared to Lagricel® Ofteno Single Dose on the Ocular Surface of Clinically Healthy Subjects
- ClinicalTrials.gov ID
- NCT04081610
- Acronym / sponsor ID
- PRO-037 / SOPH037-0119/I
- Conditions
- Dry Eye
- Keywords
- Dry eye, eye lubricant, sodium hyaluronate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Laboratorios Sophia S.A de C.V.Industry (pharma, biotech, devices)
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 23 Oct 2019 (actual)
- Study completion
- 13 Nov 2019 (actual)
- First posted
- 9 Sep 2019 (actual)
- Results
- Posted 3 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- single-center, controlled, parallel group, open, randomized
| Arm | Type | Receives |
|---|---|---|
| Lagricel® Ofteno Multidose | Experimental | Drug: lagricel ofteno multidoseLagricel® Ofteno Multidose 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia |
| Lagricel® Ofteno Single dose | Active comparator | Drug: lagricel ofteno single doseLagricel® Ofteno single dose. 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lagricel ofteno multidoseAlso: sodium hyaluronate 0.4%* Dosage: 1 drop 4 times a day per 7 days, both eyes * Route of administration: Ophthalmic | Drug | Lagricel® Ofteno Multidose |
| lagricel ofteno single doseAlso: sodium hyaluronate 0.4%* Dosage: 1 drop 4 times a day per 7 days, both eyes * Route of administration: Ophthalmic | Drug | Lagricel® Ofteno Single dose |
Primary outcome
Presence of Adverse Events (AEs)
Time frame: 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
Eye Comfort Index (ECI)
Time frame: 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).
5 secondary outcomes
Visual Acuity (VA)
Time frame: will be evaluated at the end of the treatment (day 8, final visit)
Epithelial Defects (ED) Fluorescein Stain
Time frame: will be evaluated at the end of the treatment (day 8, final visit)
Epithelial Defects (ED) Green Lissamine
Time frame: will be evaluated at the end of the treatment (day 8, final visit)
Conjunctival Hyperemia (CH)
Time frame: will be evaluated at the end of the treatment (day 8, final visit)
Chemosis
Time frame: will be evaluated at the end of the treatment (day 8, final visit)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34707360Munoz-Villegas P, Navarro-Sanchez AA, Sanchez-Rios A, Olvera-Montano O, Baiza-Duran LM. Reexamining Ophthalmic Drugs, Safety and Tolerability in Phase 1 Clinical Trials. Ther Clin Risk Manag. 2021 Oct 21;17:1123-1134. doi: 10.2147/TCRM.S331294. eCollection 2021.
- Individual participant dataSharing planned: No. Laboratorios Sophia, S.A. de C.V., serving as the sponsor of the study, assumes full responsibility for its function and retains exclusive ownership rights over the results of the study. The principal investigator undertakes not to publish or communicate data collected from the study, unless there is prior written agreement of Laboratorios Sophia, S.A. de C.V.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leopoldo Baiza Durán, MD study director
Laboratorios Sophia S.A de C.V.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing lagricel ofteno multidose and lagricel ofteno single dose in people with Dry Eye, run by Laboratorios Sophia S.A de C.V. at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Adverse Events (AEs) (time frame: during the 10 days of evaluation, including the safety call (day 11).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04081610, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.