Phase I Clinical Study to Evaluate the Safety and Tolerability of PRO-190 Ophthalmic Solution Compared to Systane Ultra® on the Ocular Surface of Ophthalmologically and Clinically Healthy Volunteers.
Overview
- Phase
- Phase 1
- Intervention
- PRO-190
- Conditions
- Dry Eye
- Sponsor
- Laboratorios Sophia S.A de C.V.
- Enrollment
- 32
- Primary Endpoint
- Incidence Unexpected Related Adverse Reactions
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
This is a phase I clinical study to evaluate the safety and tolerability of PRO-190 ophthalmic solution through the incidence of unexpected adverse events, changes in Best Corrected Visual Acuity (BCVA), changes in ocular surface integrity, changes in the ocular comfort index (OCI) score, and IOP measurement compared to Systane Ultra®.
Detailed Description
The variables to be evaluated include: Primary (safety): Incidence Unexpected Related Adverse Reactions Secondary: Changes in the ocular comfort index (OCI) score in between interventions Changes in Best Corrected Visual Acuity (BCVA) Changes in tear film breakup time Changes in intraocular pressure (IOP) Changes in the integrity of the ocular surface (fluorescein staining) Changes in lissamine green staining
Investigators
Eligibility Criteria
Inclusion Criteria
- •Having the ability to voluntarily give their signed informed consent.
- •Clinically healthy subjects.
- •Being able to and willing to comply with scheduled visits, treatment plan, and other study procedures.
- •Age ≥ 18 years.
- •No history of contact lens wear
- •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 ied consent form \[ICF\]) of the use of a hormonal contraceptive method or intrauterine device (IUD) during the study period.
- •Having vital signs within normal parameters.
- •Best corrected visual acuity (BCVA) of 20/30 or better in both eyes.
- •Having an intraocular pressure ≥ 10 and ≤ 21 mmHg.
Exclusion Criteria
- •History of hypersensitivity to 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.
- •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.
- •Diagnosis of glaucoma or ocular hypertension.
- •Known diagnosis of liver or heart disease.
- •Presenting active inflammatory or infectious disease at the time of entry into the study.
Arms & Interventions
PRO-190
Propylene glycol 0.3% - Polyethylene glycol 400 0.3%. Ophthalmic solution. Dosage: 1 drop QID \[4\] (4 times per day, at least three hours apart between doses) for 7 days in both eyes, Route of administration: Ophthalmic.
Intervention: PRO-190
Systane Ultra®
Propylene glycol 0.3% - Polyethylene glycol 400 0.4%. Ophthalmic solution. Dosage: 1 drop QID \[4\] (4 times per day, at least three hours apart between doses) for 7 days in both eyes, Route of administration: Ophthalmic.
Intervention: Systane Ultra®
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), 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 lissamine green staining(Through study completion, an average of 12 days. Evaluations will take place on days 0 (Basal Visit), and 8 (Final Visit) after the inclusion of each subject.)
- Changes in the ocular comfort index (OCI) score in between interventions(Through study completion, an average of 12 days. Evaluations will take place on days 0 (Basal Visit), and 8 (Final Visit) after the inclusion of each subject.)
- Changes in intraocular pressure (IOP)(Through study completion, an average of 12 days. Evaluations will take place on days 0 (Basal Visit), and 8 (Final Visit) after the inclusion of each subject.)
- Changes in Best Corrected Visual Acuity (BCVA)(Through study completion, an average of 12 days. Evaluations will take place on days 0 (Basal Visit), and 8 (Final Visit) after the inclusion of each subject.)
- Changes in tear film breakup time(Through study completion, an average of 12 days. Evaluations will take place on days 0 (Basal Visit), and 8 (Final Visit) after the inclusion of each subject.)
- Changes in the integrity of the ocular surface (fluorescein staining)(Through study completion, an average of 12 days. Evaluations will take place on days 0 (Basal Visit), and 8 (Final Visit) after the inclusion of each subject.)