A Phase 4 interventional study of Manzanilla Sophia® and Meticel Ofteno® in Eye Strain and Eye Strain of Both Eyes, sponsored by Laboratorios Sophia S.A de C.V.. Withdrawn. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-14.
Sponsored by Laboratorios Sophia S.A de C.V. · Phase 4, Interventional, and Treatment
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).
Primary:
-Analog visual eyestrain test score
Secondary:
67 studies on the registry are indexed under Asthenopia; 10 are open to participants now.
Browse Asthenopia studies →Laboratorios Sophia S.A de C.V. is the lead sponsor of 45 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Elimination Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Matricaria recutita 0.025%, Ophthalmic solution. * Dosage: 1 drop every 4 hours (4 daily applications \[QID\]), during 7 days. * Route of administration: Topical ophthalmic.
Drug: Manzanilla Sophia®
Hypromellose 0.5%. Ophthalmic solution. * Dosage: 1 drop every 4 hours (4 daily applications \[QID\]), during 7 days * Route of administration: Topical ophthalmic.
Drug: Meticel Ofteno®
Matricaria recutita 0.025%, Ophthalmic solution.
Hypromellose 0.5%, Ophthalmic solution.
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).
Time frame: Days: 0 (Basal Visit) and 8 (Final Visit).
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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)
The subject will be questioned directly by de PI during the final visit.
Time frame: Day 8 (Final Visit)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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