Ophthalmological Agent ToxicityPhase 4NCT06859476
Evaluation of Manzanilla® and Meticel Ofteno® 0.5% for Providing a Relief Sensation to the Eyes
A Phase 4 study testing Manzanilla Sophia® and Meticel Ofteno® 0.5% in people with Ophthalmological Agent Toxicity, run by Laboratorios Sophia S.A de C.V. at 1 site in Mexico.
Trial summary
Demonstrate the non-inferiority of Manzanilla Sophia® compared to Meticel Ofteno® 0.5% in providing a sensation of eye relief, through the score of an analogous visual test for eye fatigue. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ophthalmological Agent Toxicity
- What is being tested?
- Manzanilla Sophia® and Meticel Ofteno® 0.5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 1 siteMexico
- Study dates
- 23 May 2025to 23 Sep 2025
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to voluntarily provide signed informed consent.
- Able and willing to comply with the scheduled visits, treatment plan, and other study procedures.
- Be of legal age.
- Women of reproductive age who have not undergone bilateral tubal ligation or hysterectomy must ensure the continued use (initiated ≥ 30 days prior to signing the - - Informed Consent Form [ICF]) of a hormonal contraceptive method or intrauterine device (IUD) during the study period.
- A score of ≥ 3 on the analogous visual test for eye fatigue in at least 4 of the included questions.
Who cannot join
- Pregnant women, breastfeeding women, or those planning to become pregnant during the study period.
- Having participated in another clinical research study ≤ 30 days prior to the screening visit.
- Having previously participated in this study.
- Having only one functional eye.
- A history of current or past drug addiction or substance dependence within the last two years prior to signing the ICF.
- Current user of soft or hard contact lenses. They may be included if they suspend use during the study, and they must be lens-free for 15 days prior to inclusion.
- Known hypersensitivity to the components of the investigational products.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Unidad Clinica de Bioequivalencia (UNEBI), S de R.L de C.V.
Guadalajara, Jalisco
About this study
Official title: Study of Non-inferiority Between Manzanilla Sophia® and Meticel Ofteno® 0.5% for Providing a Relief Sensation to the Eyes
Demonstrate the non-inferiority of Manzanilla Sophia® compared to Meticel Ofteno® 0.5% in providing a sensation of eye relief, through the score of an analogous visual test for eye fatigue.
Read the detailed description
Primary Objective:
Demonstrate the non-inferiority of Manzanilla Sophia® compared to Meticel Ofteno® 0.5% in providing a sensation of eye relief, through the score of an analogous visual test for eye fatigue.
Secondary Objectives:
Signs and Symptoms Evaluated:
- Compare Manzanilla Sophia® to Meticel Ofteno® 0.5% in the incidence of red eye.
- Compare Manzanilla Sophia® to Meticel Ofteno® 0.5% in the incidence of dry eye sensation.
- Compare Manzanilla Sophia® to Meticel Ofteno® 0.5% in the incidence of eye irritation.
- Compare Manzanilla Sophia® to Meticel Ofteno® 0.5% in the incidence of sensation of eye discharge (sleep).
- Compare Manzanilla Sophia® to Meticel Ofteno® 0.5% in the incidence of comfort with the application of the investigational product (IP).
Safety Assessment:
- Compare the incidence of adverse events (AEs) related to the interventions.
- Conditions
- Ophthalmological Agent Toxicity
- Being tested
- Manzanilla Sophia®, Meticel Ofteno® 0.5%
- Keywords
- Matricaria Recutita
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manzanilla Sophia®Drug
Ophthalmic solution. Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, Mexico.
Route of Administration: Ophthalmic.
Meticel Ofteno® 0.5%Drug
Ophthalmic solution. Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, Mexico.
Route of Administration: Ophthalmic.
| Study group | Role | What they receive |
|---|---|---|
| Manzanilla Sophia® | Experimental | Matricaria recutita 0.025%. One drop four times per day (QID), with a minimun interval of 3 hours between administrations, for 7 days. Receives: Drug: Manzanilla Sophia® |
| Meticel Ofteno® 0.5% | Active comparator | Hydroxypropyl methylcellulose 0.5%. One drop QID, with a minimun interval of 3 hours between administrations, for 7 days. Receives: Drug: Meticel Ofteno® 0.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Proportion of Participants Who Decreased ≥ 6 Points or the Equivalent of 20% or More in the Visual Analog Test Score Compared to Their Baseline
To demonstrate the non-inferiority of Manzanilla Sophia® compared to Meticel Ofteno® 0.5% in providing a sensation of eye relief, through the score of an analogous visual test for eye fatigue. Based on other tools previously used for the assessment of eye fatigue, the visual analog test for eye fatigue used in this protocol is adapted and created. This test includes the following questions: "Have you had a headache?", "Have you had eye strain?", "Do you have gritty sensation in your eyes?", "Have your eyes been itchy?", "How would you describe your clarity of sight?", "Do you feel any discomfort when you fix your eyes?". Each of these questions will be answered according to a Likert scale of 1-5. The sum of the answers, the total score, will be measured in a scale from 6 to 30. A higher score is a a worse outcome for this variable.
Measured: Day 8 (Final visit)
Secondary outcomes (5)
Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the Incidence of Red Eye
The presence of red eye (presence/absence) will be assessed based on direct observation by the investigator.
Measured: Day 0 (Basal visit), Day 8 (Final visit)
Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the Incidence of Dry Eye Sensation.
This symptom was obtained by direct questioning of the subject by the principal investigator, and the response was recorded as present/absent.
Measured: Day 0 (Basal visit), Day 8 (Final visit)
Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the Incidence of Eye Irritation
This symptom was obtained by direct questioning of the subject by the principal investigator, and the response was recorded as present/absent.
Measured: Day 0 (Basal visit), Day 8 (Final visit)
Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the Incidence of Sensation of Eye Discharge.
This symptom was obtained by direct questioning of the subject by the principal investigator, and the response was recorded as present/absent.
Measured: Day 0 (Basal visit), Day 8 (Final visit)
Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the Incidence of Comfort With the Application of the Investigational Product (IP).
This result was obtained by the principal investigator directly questioning the subject, and the response was recorded as present/absent.
Measured: 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 posted5 Mar 2025
- Study start23 May 2025
- Primary completion23 Sep 2025
- Study completion23 Sep 2025
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.
- Other trials for Ophthalmological Agent ToxicityStudies 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Sophia S.A de C.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06859476
- Sponsor's protocol ID
- SOPHMAN-0824/IV
- Status last verified
- Mar 2026
- First submitted
- 27 Feb 2025
- Last updated
- 8 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Non-inferiority Between Manzanilla Sophia® and Meticel Ofteno® 0.5% for Providing a Relief Sensation to the Eyes
- ClinicalTrials.gov ID
- NCT06859476
- Acronym / sponsor ID
- SOPHMAN-0824/IV
- Conditions
- Ophthalmological Agent Toxicity
- Keywords
- Matricaria Recutita
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Laboratorios Sophia S.A de C.V.Industry (pharma, biotech, devices)
- Study start
- 23 May 2025 (actual)
- Primary completion
- 23 Sep 2025 (actual)
- Study completion
- 23 Sep 2025 (actual)
- First posted
- 5 Mar 2025 (actual)
- Results
- Posted 8 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Demonstrate the non-inferiority of Manzanilla Sophia® compared to Meticel Ofteno® 0.5% in providing a sensation of eye relief, through the score of an analogous visual test for eye fatigue.
Detailed description
Primary Objective:
Demonstrate the non-inferiority of Manzanilla Sophia® compared to Meticel Ofteno® 0.5% in providing a sensation of eye relief, through the score of an analogous visual test for eye fatigue.
Secondary Objectives:
Signs and Symptoms Evaluated:
- Compare Manzanilla Sophia® to Meticel Ofteno® 0.5% in the incidence of red eye.
- Compare Manzanilla Sophia® to Meticel Ofteno® 0.5% in the incidence of dry eye sensation.
- Compare Manzanilla Sophia® to Meticel Ofteno® 0.5% in the incidence of eye irritation.
- Compare Manzanilla Sophia® to Meticel Ofteno® 0.5% in the incidence of sensation of eye discharge (sleep).
- Compare Manzanilla Sophia® to Meticel Ofteno® 0.5% in the incidence of comfort with the application of the investigational product (IP).
Safety Assessment:
- Compare the incidence of adverse events (AEs) related to the interventions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manzanilla Sophia® | Experimental | Drug: Manzanilla Sophia®Matricaria recutita 0.025%. One drop four times per day (QID), with a minimun interval of 3 hours between administrations, for 7 days. |
| Meticel Ofteno® 0.5% | Active comparator | Drug: Meticel Ofteno® 0.5%Hydroxypropyl methylcellulose 0.5%. One drop QID, with a minimun interval of 3 hours between administrations, for 7 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ability to voluntarily provide signed informed consent.
- Able and willing to comply with the scheduled visits, treatment plan, and other study procedures.
- Be of legal age.
- Women of reproductive age who have not undergone bilateral tubal ligation or hysterectomy must ensure the continued use (initiated ≥ 30 days prior to signing the - - Informed Consent Form [ICF]) of a hormonal contraceptive method or intrauterine device (IUD) during the study period.
- A score of ≥ 3 on the analogous visual test for eye fatigue in at least 4 of the included questions.
Key exclusion criteria (7 listed)
- Pregnant women, breastfeeding women, or those planning to become pregnant during the study period.
- Having participated in another clinical research study ≤ 30 days prior to the screening visit.
- Having previously participated in this study.
- Having only one functional eye.
- A history of current or past drug addiction or substance dependence within the last two years prior to signing the ICF.
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 |
|---|---|---|
| Manzanilla Sophia®Ophthalmic solution. Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, Mexico. Route of Administration: Ophthalmic. | Drug | Manzanilla Sophia® |
| Meticel Ofteno® 0.5%Ophthalmic solution. Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, Mexico. Route of Administration: Ophthalmic. | Drug | Meticel Ofteno® 0.5% |
Primary outcome
The Proportion of Participants Who Decreased ≥ 6 Points or the Equivalent of 20% or More in the Visual Analog Test Score Compared to Their Baseline
Time frame: Day 8 (Final visit)
To demonstrate the non-inferiority of Manzanilla Sophia® compared to Meticel Ofteno® 0.5% in providing a sensation of eye relief, through the score of an analogous visual test for eye fatigue. Based on other tools previously used for the assessment of eye fatigue, the visual analog test for eye fatigue used in this protocol is adapted and created. This test includes the following questions: "Have you had a headache?", "Have you had eye strain?", "Do you have gritty sensation in your eyes?", "Have your eyes been itchy?", "How would you describe your clarity of sight?", "Do you feel any discomfort when you fix your eyes?". Each of these questions will be answered according to a Likert scale of 1-5. The sum of the answers, the total score, will be measured in a scale from 6 to 30. A higher score is a a worse outcome for this variable.
5 secondary outcomes
Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the Incidence of Red Eye
Time frame: Day 0 (Basal visit), Day 8 (Final visit)
Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the Incidence of Dry Eye Sensation.
Time frame: Day 0 (Basal visit), Day 8 (Final visit)
Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the Incidence of Eye Irritation
Time frame: Day 0 (Basal visit), Day 8 (Final visit)
Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the Incidence of Sensation of Eye Discharge.
Time frame: Day 0 (Basal visit), Day 8 (Final visit)
Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the Incidence of Comfort With the Application of the Investigational Product (IP).
Time frame: 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 8 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Manzanilla Sophia® and Meticel Ofteno® 0.5% in people with Ophthalmological Agent Toxicity, 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 5 inclusion and 7 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 8 Apr 2026. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 8 Apr 2026). 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?
The Proportion of Participants Who Decreased ≥ 6 Points or the Equivalent of 20% or More in the Visual Analog Test Score Compared to Their Baseline (time frame: Day 8 (Final visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2026.