Myopia
Conditions
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)
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.
Interventions
DRUGAtropine Sulfate
Atropine Sulfate 0.05% Ophthalmic Solution
Sponsors
Laboratorios Sophia S.A de C.V.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Phase I, non comparative, open, unicentric.
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Pupillary Diameter | Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)] | Change of pupillary diameter after exposure to the investigation product. |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Outcome results
None listed