Eye StrainPhase 4NCT06373653
Study of Non-inferiority Between Manzanilla Sophia® and Meticel Ofteno® 0.5% for Providing a Soothing Sensation to the Eyes.
A Phase 4 study testing Manzanilla Sophia® and Meticel Ofteno® in people with Eye Strain and Eye Strain of Both Eyes, run by Laboratorios Sophia S.A de C.V..
Trial summary
This is a phase IV clinical study to demonstrate the non-inferiority of Manzanilla Sophia® compared to Meticel Ofteno® 0.5% in providing restful sensation to the eyes. This will be evaluated by measuring the incidence of unexpected adverse events related to the interventions, the incidence of conjunctival hyperemia… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Eye Strain, Eye Strain of Both Eyes
- What is being tested?
- Manzanilla Sophia® and Meticel Ofteno®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 11 Feb 2025to 11 Feb 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Having the ability to voluntarily give their signed informed consent.
- Being able to and willing to comply with scheduled visits, treatment plan, and other study procedures.
- Age ≥18 years.
- Women of childbearing potential who have not undergone Bilateral Tubal Occlusion (BTO [Tubal Ligation]), hysterectomy, or bilateral oophorectomy must ensure continuation (initiated ≥ 30 days prior to signing the informed consent form [ICF]) of the use of a hormonal contraceptive method or intrauterine device (IUD) during the study period.
- Present on the analog visual eyestrain test score ≥ 3 on at least 4 of the included questions.
Who cannot join
- History of hypersensitivity to any of the components of the drugs under investigation.
- Use of contact lenses for a period less than two weeks prior to the start of the study, and during the intervention period of this study.
- In the case of women: being pregnant, breastfeeding, or planning to become pregnant within the study period.
- Having participated in any clinical research study 30 days prior to inclusion in this study.
- Having previously participated in this same study.
- Having a single functional eye.
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- Having a history of drug addiction or drug dependence current or within the last two years prior to signing the informed consent.
- Elimination Criteria:
- Withdrawal of their consent to participate in the study (informed consent form).
- Occurrence of a serious adverse event, whether related or not to the interventions, that in the opinion of the principal investigator (PI) and/or the sponsor, could affect the patient's fitness to safely continue with the study procedures.
- Non-tolerability or hypersensitivity to any of the drugs under investigation.
About this study
Official title: Clinical Study of Non-inferiority Between Manzanilla Sophia® and Meticel Ofteno® 0.5% for Providing a Soothing Sensation to the Eyes.
This is a phase IV clinical study to demonstrate the non-inferiority of Manzanilla Sophia® compared to Meticel Ofteno® 0.5% in providing restful sensation to the eyes. This will be evaluated by measuring the incidence of unexpected adverse events related to the interventions, the incidence of conjunctival hyperemia and the incidence of sensation of comfort with the application, when applied by the Principal Investigator (PI).
Read the detailed description
Primary:
-Analog visual eyestrain test score
Secondary:
- Incidence of unexpected adverse events related to the interventions
- Incidence of conjunctival hyperemia
- Incidence of sensation of ocular dryness
- Incidence of ocular irritation
- Incidence of sensation of (sleep-crust)
- Incidence of sensation of comfort with the application, when applied by the Principal Investigator (PI)
- Conditions
- Eye Strain, Eye Strain of Both Eyes
- Being tested
- Manzanilla Sophia®, Meticel Ofteno®
- Medical subject headings
- Asthenopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manzanilla Sophia®Drug
Matricaria recutita 0.025%, Ophthalmic solution.
Meticel Ofteno®Drug
Hypromellose 0.5%, Ophthalmic solution.
| Study group | Role | What they receive |
|---|---|---|
| Manzanilla Sophia® | Active comparator | Matricaria recutita 0.025%, Ophthalmic solution.
* Dosage: 1 drop every 4 hours (4 daily applications [QID]), during 7 days.
* Route of administration: Topical ophthalmic. Receives: Drug: Manzanilla Sophia® |
| Meticel Ofteno® | Active comparator | Hypromellose 0.5%. Ophthalmic solution.
* Dosage: 1 drop every 4 hours (4 daily applications [QID]), during 7 days
* Route of administration: Topical ophthalmic. Receives: Drug: Meticel Ofteno® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analog visual eyestrain test score
The PI will evaluate the analog visual eyestrain test score by applying a direct questionnaire to the subject and allowing the subject to answer it calmly without any pressure.
The analog visual test score is a questionnaire designed to establish the degree of eyestrain (fatigue) according to its symptomatology. This questionnaire will be as follows for frequency: never (1), sometimes (2), 50% of the time (3), almost all the time (4) and all the time (5).
Measured: Days: 0 (Basal Visit) and 8 (Final Visit).
Secondary outcomes (6)
Incidence of unexpected adverse events related to the interventions
Any unfavorable medical condition affecting the subject after the administration of the investigation product, related to such intervention.
Measured: Days 0 (Basal Visit), 3 (Visit 1), 8 (Final Visit) and 10 (Safety Call)
Incidence of conjunctival hyperemia
Any signs of conjunctival hyperemia in between interventions.
Conjunctival hyperemia is defined as the red appearance secondary to vasodilatation of the conjunctival blood vessels of variable intensity.
Measured: Days 0 (Basal Visit), Days 3 (Visit 1) and 8 (Final Visit)
Incidence of sensation of ocular dryness.
The subject will be questioned directly.
Ocular dryness is defined as the subjective sensation of dry eye.
Measured: Days 0 (Basal Visit), Days 3 (Visit 1) and 8 (Final Visit)
Incidence of ocular irritation
The subject will be questioned directly.
Ocular irritation is defined as the subjective sensation of eye irritation.
Measured: Days 0 (Basal Visit), Days 3 (Visit 1) and 8 (Final Visit)
Incidence of sensation of (sleep-crust)
The subject will be questioned directly.
Sleep crust is defined as the subjective sensation of the presence of eye discharge.
Measured: Days 0 (Basal Visit), Days 3 (Visit 1) and 8 (Final Visit)
Incidence of sensation of comfort with the application, when applied by the Principal Investigator (PI)
The subject will be questioned directly by de PI during the final visit.
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 posted18 Apr 2024
- Study start11 Feb 2025 (estimated)
- Primary completion11 Feb 2025
- Study completion11 Feb 2025
Why it stopped: Sponsor's decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye StrainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase IV non-inferiority, open-label, controlled, comparative, multicenter, clinical study.
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT06373653
- Sponsor's protocol ID
- SOPHMAN-0922/IV
- Status last verified
- Feb 2025
- First submitted
- 15 Apr 2024
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Non-inferiority Between Manzanilla Sophia® and Meticel Ofteno® 0.5% for Providing a Soothing Sensation to the Eyes.
- ClinicalTrials.gov ID
- NCT06373653
- Acronym / sponsor ID
- SOPHMAN-0922/IV
- Conditions
- Eye Strain, Eye Strain of Both Eyes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor's decision.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Laboratorios Sophia S.A de C.V.Industry (pharma, biotech, devices)
- Study start
- 11 Feb 2025 (estimated)
- Primary completion
- 11 Feb 2025 (actual)
- Study completion
- 11 Feb 2025 (actual)
- First posted
- 18 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase IV clinical study to demonstrate the non-inferiority of Manzanilla Sophia® compared to Meticel Ofteno® 0.5% in providing restful sensation to the eyes. This will be evaluated by measuring the incidence of unexpected adverse events related to the interventions, the incidence of conjunctival hyperemia and the incidence of sensation of comfort with the application, when applied by the Principal Investigator (PI).
Detailed description
Primary:
-Analog visual eyestrain test score
Secondary:
- Incidence of unexpected adverse events related to the interventions
- Incidence of conjunctival hyperemia
- Incidence of sensation of ocular dryness
- Incidence of ocular irritation
- Incidence of sensation of (sleep-crust)
- Incidence of sensation of comfort with the application, when applied by the Principal Investigator (PI)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase IV non-inferiority, open-label, controlled, comparative, multicenter, clinical study.
| Arm | Type | Receives |
|---|---|---|
| Manzanilla Sophia® | Active comparator | Drug: Manzanilla Sophia®Matricaria recutita 0.025%, Ophthalmic solution. * Dosage: 1 drop every 4 hours (4 daily applications [QID]), during 7 days. * Route of administration: Topical ophthalmic. |
| Meticel Ofteno® | Active comparator | Drug: Meticel Ofteno®Hypromellose 0.5%. Ophthalmic solution. * Dosage: 1 drop every 4 hours (4 daily applications [QID]), during 7 days * Route of administration: Topical ophthalmic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Having the ability to voluntarily give their signed informed consent.
- Being able to and willing to comply with scheduled visits, treatment plan, and other study procedures.
- Age ≥18 years.
- Women of childbearing potential who have not undergone Bilateral Tubal Occlusion (BTO [Tubal Ligation]), hysterectomy, or bilateral oophorectomy must ensure continuation (initiated ≥ 30 days prior to signing the informed consent form [ICF]) of the use of a hormonal contraceptive method or intrauterine device (IUD) during the study period.
- Present on the analog visual eyestrain test score ≥ 3 on at least 4 of the included questions.
Key exclusion criteria (11 listed)
- History of hypersensitivity to any of the components of the drugs under investigation.
- Use of contact lenses for a period less than two weeks prior to the start of the study, and during the intervention period of this study.
- In the case of women: being pregnant, breastfeeding, or planning to become pregnant within the study period.
- Having participated in any clinical research study 30 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 |
|---|---|---|
| Manzanilla Sophia®Matricaria recutita 0.025%, Ophthalmic solution. | Drug | Manzanilla Sophia® |
| Meticel Ofteno®Hypromellose 0.5%, Ophthalmic solution. | Drug | Meticel Ofteno® |
Primary outcome
Analog visual eyestrain test score
Time frame: Days: 0 (Basal Visit) and 8 (Final Visit).
The PI will evaluate the analog visual eyestrain test score by applying a direct questionnaire to the subject and allowing the subject to answer it calmly without any pressure. The analog visual test score is a questionnaire designed to establish the degree of eyestrain (fatigue) according to its symptomatology. This questionnaire will be as follows for frequency: never (1), sometimes (2), 50% of the time (3), almost all the time (4) and all the time (5).
6 secondary outcomes
Incidence of unexpected adverse events related to the interventions
Time frame: Days 0 (Basal Visit), 3 (Visit 1), 8 (Final Visit) and 10 (Safety Call)
Incidence of conjunctival hyperemia
Time frame: Days 0 (Basal Visit), Days 3 (Visit 1) and 8 (Final Visit)
Incidence of sensation of ocular dryness.
Time frame: Days 0 (Basal Visit), Days 3 (Visit 1) and 8 (Final Visit)
Incidence of ocular irritation
Time frame: Days 0 (Basal Visit), Days 3 (Visit 1) and 8 (Final Visit)
Incidence of sensation of (sleep-crust)
Time frame: Days 0 (Basal Visit), Days 3 (Visit 1) and 8 (Final Visit)
Incidence of sensation of comfort with the application, when applied by the Principal Investigator (PI)
Time frame: Day 8 (Final Visit)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Manzanilla Sophia® and Meticel Ofteno® in people with Eye Strain and Eye Strain of Both Eyes, run by Laboratorios Sophia S.A de C.V..
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 11 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: withdrawn, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Analog visual eyestrain test score (time frame: Days: 0 (Basal Visit) and 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 14 Feb 2025.