Phase I Clinical Trial to Evaluate the Safety and Tolerability of Ophtalmic Solution PRO-201
Study Details
Study Description
Brief Summary
Evaluation of the safety and tolerability of PRO-201 (0.01% sulfate atropine) after its instillation on the ocular surface of healthy volunteers through the following variables: unexpected adverse events incidence and photophobia (primary outcome variables); as well as pupillary diameter, expected adverse events incidence, best near corrected visual acuity (BNCVA), best corrected visual acuity (BCVA), intraocular pressure (IOP), corneal and conjunctival staining, heart rate, blood pressure and ocular confort index (OCI),
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Detailed Description
A total of 29 healthy volunteers will be enrolled in this study. They will receive one drop of the investigation product PRO-201 (0.01% atropine sulfate) once a day (QD) for a total of 14 days on both eyes. A final safety call will be performed one week after the last day of product application.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: PRO-201 A total of 29 anticipated healthy volunteers will be exposed to the investigation product. |
Drug: Atropine Sulfate
Administration of one drop QD on both eyes for 14 days.
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Outcome Measures
Primary Outcome Measures
- 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.
- Incidence of photophobia [Through Day 21 ± 1 (Safety Call)]
The number of cases of photophobia.
Secondary Outcome Measures
- Pupillary Diameter [Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)]
Measurement of pupillary diameter after exposure to the investigation product.
- Incidence of expected adverse events [Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit), 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.
- Measurement of the change in best near corrected visual acuity (BNCVA) [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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
Inclusion Criteria:
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Being clinically healthy
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Ability to voluntarily sign an informed consent form (ICF).
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Ability and willingness to comply with the scheduled visits according to the intervention plan and other procedures of the study.
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Age between 18 and 35.
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Absence of history of contact lens use.
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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.
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Best corrected visual acuity (BVCA) of at least 20/30 (logMAR 0.2) or better in both eyes.
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Best near corrected visual acuity (BNVCA) of at least 20/25 (logMAR 0.1) or better in both eyes.
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Presenting vital signs within normal parameters.
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Presenting an IOP ≥10 and ≤ 21 mmHg
Exclusion Criteria:
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Using any kind of ophthalmic topical products.
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Presenting known allergy or intolerance to any ingrediente of atropine eyedrops or any other derivatives of antimuscarinic agents.
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Using any medication of herbolary products (plant extracts, infusions, naturist preparations, homeopathy, etc) through any route of administration
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For women: being pregnant, breastfeeding or planning to get pregnant during the period of the study.
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Having participated in any clinical study 90 days prior to the inclusion in this study.
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Having participated in this clinical study.
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Inability to follow the lifestyle considerations of this study.
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History of any chronic degenerative disease, including diabetes and hypertension.
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Presenting active inflammatory or infectious diseases when entering this study.
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Presenting unresolved lesions or trauma when entering this study.
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History of any ocular surgery.
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History of any surgery, non-ocular, within the previous 3 months of entering this studies.
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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.
Elimination criteria:
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Withdraw of ICF.
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Adverse event, related or not to the investigation product, that according to the principal investigator and/or the sponsor may affect the integrity of the patient to continue safely with the study's procedures.
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Hypersensitivity or lack of tolerance to any of the ingredients used during the study's procedures (fluorescein, lissamine green, tetracaine, etc)
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Hypersensitivity or lack of tolerance to the investigation product.
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Presenting an adherence to treatment < 90%, as determined through the subjects diary.
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.- SOPH201-0521/I