Clinical trial NCT06373653: Study of Non-inferiority Between Manzanilla Sophia® and Meticel Ofteno® 0.5% for Providing a Soothing Sensation to the Eyes.
Official title: Clinical Study of Non-inferiority Between Manzanilla Sophia® and Meticel Ofteno® 0.5% for Providing a Soothing Sensation to the Eyes.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Eye Strain
Eye Strain of Both Eyes
Lead sponsor: Laboratorios Sophia S.A de C.V.
Sponsor class: INDUSTRY
First posted: 2024-04-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase IV non-inferiority, open-label, controlled, comparative, multicenter, clinical study.
Primary purpose: TREATMENT

Brief 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 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)

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Analog visual eyestrain test score
timeFrame: Days: 0 (Basal Visit) and 8 (Final Visit).
Secondary outcomes:
measure: Incidence of unexpected adverse events related to the interventions
timeFrame: Days 0 (Basal Visit), 3 (Visit 1), 8 (Final Visit) and 10 (Safety Call)
measure: Incidence of conjunctival hyperemia
timeFrame: Days 0 (Basal Visit), Days 3 (Visit 1) and 8 (Final Visit)
measure: Incidence of sensation of ocular dryness.
timeFrame: Days 0 (Basal Visit), Days 3 (Visit 1) and 8 (Final Visit)
measure: Incidence of ocular irritation
timeFrame: Days 0 (Basal Visit), Days 3 (Visit 1) and 8 (Final Visit)
measure: Incidence of sensation of (sleep-crust)
timeFrame: Days 0 (Basal Visit), Days 3 (Visit 1) and 8 (Final Visit)
measure: Incidence of sensation of comfort with the application, when applied by the Principal Investigator (PI)
timeFrame: Day 8 (Final Visit)
Other outcomes:
Locations:
Study officials:
References: