Phase I Clinical Study to Evaluate the Safety and Tolerability of PRO-229 Ophthalmic Solution Compared to Lagricel® Ofteno PF in Clinically Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- PRO-229
- Conditions
- Dry Eye Disease
- Sponsor
- Laboratorios Sophia S.A de C.V.
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Incidence Unexpected Related Adverse Reactions
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This is a phase I study evaluating safety and tolerability of PRO-229 ophthalmic solution through he incidence of unexpected adverse events, changes in Best Corrected Visual Acuity (BCVA), incidence of chemosis, and changes in ocular surface staining using the Sjögren's International Collaborative Clinical Alliance (SICCA) Ocular Staining Score (OSS) scale compared to Lagricel® Ofteno PF in clinically healthy subjects.
Detailed Description
The variables to be evaluated include: Primary objective: - To evaluate the safety and tolerability of PRO-229 ophthalmic solution compared to Lagricel® Ofteno PF in clinically healthy subjects. Specific objective: - To compare the safety of PRO-229 formulation compared to Lagricel® Ofteno PF through the incidence of adverse events related to both investigational products. Secondary Objectives: * To compare the safety of vs. PRO-229 formulation compared to Lagricel® Ofteno PF by changes in Best Corrected Visual Acuity (BCVA). * To compare the safety of PRO-229 formulation compared to Lagricel® Ofteno PF by changes in ocular surface staining assessed with the the Sjögren's International Collaborative Clinical Alliance (SICCA) Ocular Staining Score (OSS) scale. * To compare the safety of PRO-229 formulation compared to Lagricel® Ofteno PF by the incidence of chemosis. * To compare the tolerability of PRO-229 formulation compared to Lagricel® Ofteno PF by changes in conjunctival hyperemia grades 3 or 4. * To ompare the tolerability of PRO-229 formulation compared to Lagricel® Ofteno Ophthalmic PF by adherence to treatment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Having the ability to voluntarily give their signed informed consent.
- •Ophthalmologically and clinically healthy subjects.
- •Being able to and willing to comply with scheduled visits, treatment plan, and other study procedures.
- •Age between 18 to 45 years.
- •Male or female gender.
- •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.
- •Best corrected visual acuity (BCVA) of 20/30 or better in both eyes.
- •Corneal staining ≤ grade I on the Oxford Scale.
- •Having an intraocular pressure ≥ 10 and ≤ 21 mmHg.
Exclusion Criteria
- •History of hypersensitivity to fluoroquinolones, steroid anti-inflammatories, or any of the components of the drugs under investigation.
- •Use of ophthalmic medications from any pharmacological group.
- •Use of medications by any other route of administration.
- •Use of non-steroidal anti-inflammatory drugs, steroid anti-inflammatory drugs, or antibiotics by any route of administration in the last 30 days.
- •History of eye surgery in the last 6 months.
- •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.
- •History of any chronic-degenerative disease, including Diabetes Mellitus or Systemic Arterial Hypertension.
Arms & Interventions
PRO-229
* Dexpanthenol 2% and sodium hyaluronate 0.15% ophthalmic solution. * Dosage:1 drop QID \[4\] (four times per day) for 7 days on right both eyes. * Route of administration: Ophthalmic. * Presentation: Multidose dropper bottle.
Intervention: PRO-229
Lagricel® Ofteno PF
* Sodium hyaluronate 0.4%. Ophthalmic solution. * Dosage: 1 drop QID \[4\] (four times per day) for 7 days on right both eyes. * Route of administration: Ophthalmic. * Presentation: Multidose dropper bottle.
Intervention: Lagricel® Ofteno PF
Outcomes
Primary Outcomes
Incidence Unexpected Related Adverse Reactions
Time Frame: Through study completion, an average of 12 days. Evaluations will take place on days 0 (Basal Visit), 3 (Visit 1), 8 (Final Visit) and 12 (Safety Call) after the inclusion of each subject.
Any unfavorable medical condition affecting the subject after the administration of the investigation product, related to such intervention.
Secondary Outcomes
- Changes in Best Corrected Visual Acuity (BCVA)(Through an average of 8 days. Evaluations will take place on days 0 (Basal Visit), 3 (Visit 1), and 8 (Final Visit) after the inclusion of each subject.)
- Changes in ocular surface staining using SICCA ocular staining score scale(Through an average of 8 days. Evaluations will take place on days 0 (Basal Visit), 3 (Visit 1), and 8 (Final Visit) after the inclusion of each subject.)
- Incidence of chemosis(Through an average of 8 days. Evaluations will take place on days 0 (Basal Visit), 3 (Visit 1), and 8 (Final Visit) after the inclusion of each subject.)
- Incidence of grade 3 or 4 conjunctival hyperemia.(Through an average of 8 days. Evaluations will take place on days 0 (Basal Visit), 3 (Visit 1), and 8 (Final Visit) after the inclusion of each subject.)
- Adherence to treatment (adherence)(Through an average of 8 days. This evaluations will take place on days 8 (Final Visit) after the inclusion of each subject.)