MyopiaPhase 1PRO-230NCT05481489
Safety and Tolerability Evaluation of PRO-230 Ophthalmic Solution
A Phase 1 study testing Atropine Sulfate in people with Myopia, run by Laboratorios Sophia S.A de C.V..
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Atropine Sulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2023to 24 Apr 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
About this study
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.
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)
Read the 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.
- Conditions
- Myopia
- Being tested
- Atropine Sulfate
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atropine SulfateDrug
Atropine Sulfate 0.05% Ophthalmic Solution
| Study group | Role | What they receive |
|---|---|---|
| PRO-230 | Experimental | Healthy volunteers will apply one drop of PRO-230 ophthalmic solution (atropine sulphate) on both eyes, QD (one time per day) for 14 days. Receives: Drug: Atropine Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of unexpected adverse events
The number of adverse events presented that are not previously described / known for the active substance in this pharmaceutic form and concentration.
Measured: Through Day 21 ± 1 (Safety Call)
Incidence of photophobia
The number of cases of photophobia.
Measured: Through Day 21 ± 1 (Safety Call)
Secondary outcomes (3)
Pupillary Diameter
Change of pupillary diameter after exposure to the investigation product.
Measured: Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)]
Incidence of expected adverse events
The number of adverse events presented that are previously described / known for the active substance in this pharmaceutic form and concentration.
Measured: Through Day 21 ± 1 (Safety Call)
Measurement of the change in best near corrected visual acuity (BNCVA)
The change in BNCVA after exposure to investigation product, compared to basal value.
Measured: Time Frame: Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start1 Feb 2023 (estimated)
- Primary completion31 Mar 2023 (estimated)
- Study completion24 Apr 2023
Why it stopped: Due to sponsors convenience.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase I, non comparative, open, unicentric.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Sophia S.A de C.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05481489
- Sponsor's protocol ID
- SOPH230-1121/I
- Acronym
- PRO-230
- Status last verified
- Jun 2024
- First submitted
- 28 Jul 2022
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05481489
- Acronym / sponsor ID
- PRO-230 / SOPH230-1121/I
- Conditions
- Myopia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to sponsors convenience.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Laboratorios Sophia S.A de C.V.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 24 Apr 2023 (actual)
- First posted
- 1 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase I, non comparative, open, unicentric.
| Arm | Type | Receives |
|---|---|---|
| PRO-230 | Experimental | Drug: Atropine SulfateHealthy volunteers will apply one drop of PRO-230 ophthalmic solution (atropine sulphate) on both eyes, QD (one time per day) for 14 days. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atropine SulfateAtropine Sulfate 0.05% Ophthalmic Solution | Drug | PRO-230 |
Primary outcome
Incidence of unexpected adverse events
Time frame: 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
Time frame: Through Day 21 ± 1 (Safety Call)
The number of cases of photophobia.
3 secondary outcomes
Pupillary Diameter
Time frame: Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)]
Incidence of expected adverse events
Time frame: Through Day 21 ± 1 (Safety Call)
Measurement of the change in best near corrected visual acuity (BNCVA)
Time frame: Time Frame: Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Atropine Sulfate in people with Myopia, run by Laboratorios Sophia S.A de C.V..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of unexpected adverse events (time frame: Through Day 21 ± 1 (Safety Call)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024.