Phase I Clinical Study to Evaluate the Safety and Tolerability of PRO-240 Ophthalmic Solution Compared to Optive® on the Ocular Surface of Ophthalmologically and Clinically Healthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- PRO-240
- Conditions
- Dry Eye Disease
- Sponsor
- Laboratorios Sophia S.A de C.V.
- Enrollment
- 32
- Primary Endpoint
- Incidence of unexpected adverse events related to the interventions
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
This is a phase I clinical study to evaluating safety and tolerability of PRO-240 ophthalmic solution through the incidence of unexpected adverse events, as well as through changes in Best Corrected Visual Acuity (BCVA), and the incidence of stinging after its administration, compared to Optive®.
Detailed Description
The variables to be evaluated include: Primary (safety): - Incidence of unexpected advere events (AE's) Secondary: * Changes in the ocular comfort index (OCI) score * Changes in intraocular pressure (IOP) * Changes in Best Corrected Visual Acuity (BCVA) * Adherence to treatment * Changes in tear film breakup time * Changes in fluorescein staining * Changes in lissamine green staining
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 ≥18 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 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-240
* Propylene glycol 0.3% - Polyethylene glycol 400 0.5% - Glycerin 0.2%. Ophthalmic solution. * Dosage: 1 drop QID \[4\] (four times per day) for 7 days in both eyes. * Route of administration: Ophthalmic
Intervention: PRO-240
Optive®
* Carboxymethylcellulose 0.5%; Glycerin 0.9%. Ophthalmic solution. * Dosage: 1 drop QID \[4\] (four times per day) for 7 days in both eyes. * Route of administration: Ophthalmic
Intervention: Optive®
Outcomes
Primary Outcomes
Incidence of unexpected adverse events related to the interventions
Time Frame: Days 0: (Basal Visit), 8 (Final Visit) and 11 (Safety Call)
Any unfavorable medical condition affecting the subject after the administration of the investigation product, related to such intervention.
Secondary Outcomes
- Changes in the integrity of the ocular surface (fluorescein staining)(Days: 0 (Basal Visit) and 8 (Final Visit))
- Adherence to treatment (adherence) Adherence to treatment (adherence)(Days: 8 (Final Visit))
- Changes in intraocular pressure (IOP)(Days: 0 (Basal Visit) and 8 (Final Visit))
- Changes in Best Corrected Visual Acuity (BCVA)(Days: 0 (Basal Visit) and 8 (Final Visit))
- Changes in the Ocular Comfort Index score(Days: 0 (Basal Visit), and 8 (Final Visit))
- Changes in tear film breakup time(Days: 0 (Basal Visit) and 8 (Final Visit))
- Changes in lissamine green staining of the conjunctival surface(Days: 0 (Basal Visit) and 8 (Final Visit))