Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2025-12-24 @ 7:00 PM
NCT ID:
NCT03524157
Brief Summary:
Phase I clinical study, to evaluate the safety and tolerability of the preservative-free ophthalmic solution PRO-087 versus Xyel Ofteno® and Systane Ultra®, on the ocular surface of ophthalmological and clinically healthy subjects.
Objective: To evaluate the safety and tolerability of the preservative-free formulation PRO-087 manufactured by Laboratorios Sophia S.A. of C.V. on the ocular surface of clinically healthy subjects.
Hypothesis:
The ophthalmic solution PRO-087 presents a profile of safety and tolerability similar to comparators in healthy subjects
Methodology:
Phase I clinical trial, controlled, of parallel groups, double blind, randomized, exploratory.
Detailed Description:
Phase I clinical study, to evaluate the safety and tolerability of the preservative-free ophthalmic solution PRO-087 versus Xyel Ofteno® and Systane Ultra®, on the ocular surface of ophthalmological and clinically healthy subjects.
Objective: To evaluate the safety and tolerability of the preservative-free formulation PRO-087 manufactured by Laboratorios Sophia S.A. of C.V. on the ocular surface of clinically healthy subjects.
Hypothesis:
The ophthalmic solution PRO-087 presents a profile of safety and tolerability similar to comparators in healthy subjects
Methodology:
Phase I clinical trial, controlled, of parallel groups, double blind, randomized, exploratory.
Study period:
3 to 4 months
treatment duration: 10 days
Number of patients:
30 subjects, divided into 3 groups,10 subjects (20 eyes) exposed by group.
Diagnosis and main inclusion criteria:
* Systemically and ophthalmologically healthy subjects
* Signed informed consent.
* Age between 18 to 40 years
* Both genders
* Blood tests complete, blood count (BHC), three element blood chemistry (QS) and liver function tests, within normal parameters
* Visual capacity 20/30 or better
Test product, dose and route of administration:
\- PRO-087. Chondroitin sulfate 0.18% / 0.1% sodium hyaluronate, ophthalmic solution preservative free. made by Laboratorios Sophia, S.A. of C.V., Zapopan, Jalisco, Mexico.
Dosage: 1 drop 4 times a day during the waking period, both eyes Route of administration: topical ophthalmic.
Reference product, dose and route of administration:
1. Xyel Ofteno®. Xanthan gum 0.09% / Chondroitin sulfate 0.1% / preservative-free ophthalmic solution. made by Laboratorios Sophia, S.A. of C.V., Zapopan, Jalisco, Mexico.
Dosage: 1 drop 4 times a day during the waking period, both eyes Route of administration: topical ophthalmic.
2. Systane Ultra®. Polyethylene glycol 400 0.4%, propylene glycol 0.3%. made by Alcon Laboratories, Inc.
Dosage: 1 drop 4 times a day during the waking period, both eyes Route of administration: topical ophthalmic.
Evaluation criteria:
Primary security outcome variables:
* Goblet cells density .
* Presence of adverse events.
* Intraocular pressure.
* Visual ability
* Laboratory tests
* Epithelial defects in cornea and conjunctiva.
* Ophthalmological signs: conjunctival hyperemia, chemosis.
Secondary outcome variables:
* Tear film rupture time
* Life signs: heart rate, respiratory frequency systemic blood pressure.
* Subsequent segment
Primary outcome variables of tolerability:
* Burning
* Foreign body sensation
* Itching
* Eye comfort index
Statistical methodology:
The data will be expressed with measures of central tendency: mean and standard deviation for the quantitative variables. The qualitative variables will be presented in frequencies and percentages. The statistical analysis will be carried out through the Kruskal-Wallis test for quantitative variables. The difference between the qualitative variables will be analyzed by means of chi square (Chi2). An alpha ≤ 0.05 will be considered significant.
Study:
NCT03524157
Study Brief:
Protocol Section:
NCT03524157