Phase I Clinical Study to Evaluate the Safety and Tolerability of PRO-231 Ophthalmic Solution Versus VIGAMOXI® on the Ocular Surface of Ophthalmologically and Clinically Healthy Subjects.
Overview
- Phase
- Phase 1
- Intervention
- PRO-231
- Conditions
- Ophthalmological Agent Toxicity
- Sponsor
- Laboratorios Sophia S.A de C.V.
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- Incidence of Unexpected Adverse Events Related to the Interventions
- Status
- Completed
- Last Updated
- 10 months ago
Overview
Brief Summary
This is a phase I clinical study evaluating the safety and tolerability of PRO-231 ophthalmic solution through the incidence of unexpected adverse events, incidence of conjunctival hyperemia and chemosis, changes in Best Corrected Visual Acuity (BCVA), changes in ocular surface integrity, compared to VIGAMOXI®.
Detailed Description
This is a Phase I, controlled, comparative, parallel-group, single-blind, single-center, controlled clinical trial. The variables to be evaluated include: Primary (safety): * Incidence of unexpected adverse events related to the interventions * Incidence of conjunctival hyperemia and chemosis * Changes in Best Corrected Visual Acuity (BCVA) assessed with Snellen chart * Changes in ocular surface integrity using fluorescein staining, using the standard Oxford scale. Primary (tolerability): - Changes in the ocular comfort index (OCI) score Secondary (safety): - Incidence of unexpected adverse events related to the interventions(excluding conjunctival hyperemia and/or chemosis). Secondary (tolerability): - Presence of other ocular symptoms (burning, foreign body sensation, pruritus and lacrimation).
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-231
* PRO-231: Moxifloxacin 0.5% Ophthalmic solution. * Dosage: 1 drop every 6 hours (3 daily applications \[TID\], in the right eye). * Route of administration: Topical ophthalmic.
Intervention: PRO-231
VIGAMOXI®
* VIGAMOXI® :Moxifloxacin 0.5% Ophthalmic Solution. * Dosage: 1 drop every 6 hours (3 daily applications \[TID\], in the right eye). * Route of administration: Topical ophthalmic.
Intervention: VIGAMOXI®
Outcomes
Primary Outcomes
Incidence of Unexpected Adverse Events Related to the Interventions
Time Frame: Days 0 (Basal Visit), 3 (Visit 1), 8 (Final Visit) and 12 (Safety Call)
Any unfavorable medical condition affecting the subject after the administration of the investigation product, related to such intervention. Adverse events where inquired and evaluated in every time point specified in the time frame, however, the final number of adverse events reported throught the entire study was evaluated for each group.
Incidence of Conjunctival Hyperemia
Time Frame: Days 0 (Basal Visit), 3 (Visit 1), and 8 (Final Visit)
Any signs of conjunctival hyperemia in between interventions.
Changes in Best Corrected Visual Acuity (BCVA)
Time Frame: Days 0 (Basal Visit), Days 3 (Visit 1) and 8 (Final Visit)
The BCVA will be evaluated through Snellen chart.
Number of Patients With Any Changes in Grade Measurement of the Integrity of the Ocular Surface (Fluorescein Staining)
Time Frame: Days 0 (Basal Visit), Days 3 (Visit 1) and 8 (Final Visit)
Number of patients with any changes in the integrity of the ocular surface using fluorescein staining and evaluated through the Oxford scale compared to baseline. The standard Oxford scale for fluorescein staining has the following criteria: Grade 0- Equal to or less than panel A; Grade I- Equal to or less than panel B, greater than panel A; Grade II- Equal to or less than panel C, greater than panel B; Grade III- Equal or less than panel D, greater than panel C; Grade IV- Equal or less than panel E, greater than panel D; Grade V- Greater than panel E.
Changes in the Ocular Comfort Index (OCI) Score Between Interventions.
Time Frame: Days 0 (Basal Visit), and 8 (Final Visit)
The Ocular Comfort Index is a questionnaire designed to measure ocular surface irritation. It assesses symptoms related to comfort in cases of ocular surface disorders. The Ocular Comfort Index is composed of 12 items that assess the frequency and intensity symptoms. Each item is scored on a scale from 0 to 6 (never to always, or absent to severe). The total score becomes a linear continuous interval scale, which ranges from 0 (least symptomatic) to 100 (most symptomatic). The questionnaire was administered to each research subject, allowing them to respond calmly without any pressure and/or coercion. The results were collected using the Ocular Comfort Index calculator \[1\], obtaining a logit score and a 0-100 scale score for each subject. \[1\].- M. E. Johnson, "Measurement of Ocular Surface Irritation on a Linear Interval Scale with the Ocular Comfort Index," Investigative Ophthalmology \& Visual Science, vol. 48, nº 10, 2007.
Secondary Outcomes
- Incidence of Unexpected Adverse Events (Excluding Conjunctival Hyperemia and Chemosis)(Days 3 (Visit 1), 8 (Final Visit) and 12 (Safety Call))
- To Assess the Tolerability of PRO-231 Ophthalmic Solution(Days 3 (Visit 1), 8 (Final Visit))