Safety and Tolerability Evaluation of PRO-230 Ophthalmic Solution

Sponsor
Laboratorios Sophia S.A de C.V. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05481489
Collaborator
(none)
29
1
4.9

Study Details

Study Description

Brief Summary

Phase I Study to evaluate safety and tolerability of PRO-230 (atropine sulphate 0.05%) ophthalmic solution through evaluation of incidence of non-expected adverse events (AE), photophobia, pupillary diameter, incidence of expected adverse events, and best near corrected visual acuity (BNCVA)

Condition or Disease Intervention/Treatment Phase
  • Drug: Atropine Sulfate
Phase 1

Detailed Description

A total of 29 healthy volunteers will apply PRO-230 ocular solution on both eyes QD (one time per day) for 14 days. The safety variables will include non expected AE, pupillary diameter and expected AE; tolerability variables will include incidence of photofobia, and BNCVA. Exploratory variables include best corrected visual acuity (BCVA), intraocular pressure (IOP), corneal an conjunctival staining with fluorescein and lissamine green, vital signs (heart rate and blood pressure), and results of the Ocular Confort Index (OCI) questionnaire.

The presence of non-expected AE < 10% will deem PRO-230 as safe; while an incidence of photophobia < 30% will deem PRO-230 as tolerable.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
29 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Phase I, non comparative, open, unicentric.Phase I, non comparative, open, unicentric.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase I Clinical Trial to Evaluate the Safety and Tolerability of the Ophthalmic Solution PRO-230 When Applied to the Ocular Surface of Healthy Volunteers.
Anticipated Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Mar 31, 2023
Anticipated Study Completion Date :
Mar 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: PRO-230

Healthy volunteers will apply one drop of PRO-230 ophthalmic solution (atropine sulphate) on both eyes, QD (one time per day) for 14 days.

Drug: Atropine Sulfate
Atropine Sulfate 0.05% Ophthalmic Solution

Outcome Measures

Primary Outcome Measures

  1. Incidence of unexpected adverse events [Through Day 21 ± 1 (Safety Call)]

    The number of adverse events presented that are not previously described / known for the active substance in this pharmaceutic form and concentration.

  2. Incidence of photophobia [Through Day 21 ± 1 (Safety Call)]

    The number of cases of photophobia.

Secondary Outcome Measures

  1. Pupillary Diameter [Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)]]

    Change of pupillary diameter after exposure to the investigation product.

  2. Incidence of expected adverse events [Through Day 21 ± 1 (Safety Call)]

    The number of adverse events presented that are previously described / known for the active substance in this pharmaceutic form and concentration.

  3. Measurement of the change in best near corrected visual acuity (BNCVA) [Time Frame: Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)]

    The change in BNCVA after exposure to investigation product, compared to basal value.

Other Outcome Measures

  1. Measurement of the change in best corrected visual acuity (BCVA) [Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)]

    The change in BCVA after exposure to investigation product, compared to basal value.

  2. Changes in intraocular pressure (IOP) [Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)]

    The change in IOP after exposure to investigation product, compared to basal value.

  3. Incidence of corneal and conjunctival staining [Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)]]

    Presence of corneal and conjunctival staining with fluorescein and lissamine green after exposure to investigation product.

  4. Measurement of vital signs (blood pressure) [Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)]

    The change in blood pressure after exposure to investigation product, compared to basal value.

  5. Measurement of vital signs (heart rate) [Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)]

    The change in heart rate after exposure to investigation product, compared to basal value.

  6. Value of the ocular comfort index (OCI) questionnaire [Days: 1 (Basal Visit), 16 ± 1 (Final Visit)]

    The change ocular comfort index (OCI) questionnaire results after exposure to investigation product, compared to basal value.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Being clinically healthy

  • Ability to voluntarily sign an informed consent form (ICF).

  • Ability and willingness to comply with the scheduled visits according to the intervention plan and other procedures of the study.

  • Age between 18 and 35.

  • Absence of history of contact lens use.

  • Women of childbearing age must agree to continue (starting ≥ 30 days previous to the ICF) the use of a hormonal contraception method of a intrauterine device (IUD) during the period of the study.

  • Best corrected visual acuity (BVCA) of at least 20/30 (logMAR 0.2) or better in both eyes.

  • Best near corrected visual acuity (BNVCA) of at least 20/25 (logMAR 0.1) or better in both eyes.

  • Presenting vital signs within normal parameters.

  • Presenting an IOP ≥10 and ≤ 21 mmHg

Exclusion Criteria:
  • Using any kind of ophthalmic topical products.

  • Presenting known allergy or intolerance to any ingrediente of atropine eyedrops or any other derivatives of antimuscarinic agents.

  • Using any medication of herbolary products (plant extracts, infusions, naturist preparations, homeopathy, etc) through any route of administration

  • For women: being pregnant, breastfeeding or planning to get pregnant during the period of the study.

  • Having participated in any clinical study 90 days prior to the inclusion in this study.

  • Having participated in this clinical study.

  • History of any chronic degenerative disease, including diabetes and hypertension.

  • Presenting active inflammatory or infectious diseases when entering this study.

  • Presenting unresolved lesions or trauma when entering this study.

  • History of any ocular surgery.

  • History of any surgery, non-ocular, within the previous 3 months of entering this studies.

  • Being or having an direct family member (spouse, parent/legal guardian, sibling, etc) as employee of the investigation site or the sponsor, who participates directly in this study.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Laboratorios Sophia S.A de C.V.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Laboratorios Sophia S.A de C.V.
ClinicalTrials.gov Identifier:
NCT05481489
Other Study ID Numbers:
  • SOPH230-1121/I
First Posted:
Aug 1, 2022
Last Update Posted:
Aug 1, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 1, 2022