Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2025-12-25 @ 4:33 PM
Study NCT ID:
NCT03524157
Status:
COMPLETED
Last Update Posted:
2019-07-19
First Post:
2018-04-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Tolerability of PRO-087 Versus Xyel Ofteno® and Systane Ultra®, on the Ocular Surface of Healthy Subjects
Sponsor:
Laboratorios Sophia S.A de C.V.
Organization:
Study Overview
Official Title:
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 Ophthalmologically and Clinically Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRO-087/I
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: