A Phase 1 interventional study of Atropine Sulfate in Myopia, sponsored by Laboratorios Sophia S.A de C.V.. Completed at 1 site in Mexico. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-05.
Sponsored by Laboratorios Sophia S.A de C.V. · Phase 1, Interventional, and Treatment
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),
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.
984 studies on the registry are indexed under Myopia; 210 are open to participants now.
This study's enrollment of 29 is below the median of 80 across 783 interventional studies indexed under Myopia.
Browse Myopia studies →Laboratorios Sophia S.A de C.V. is the lead sponsor of 44 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Elimination criteria:
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.
Number 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.
Time frame: Through Day 21 ± 1 (Safety Call)
Number of Patients With Photophobia
The number of cases of photophobia.
Time frame: Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)
Pupillary Diameter
Measurement of pupillary diameter after exposure to the investigation product.
Time frame: Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)
Percentage of Expected Adverse Events
The percentage of adverse events presented that are expected, or previously described / known for the active substance in this pharmaceutic form and concentration.
Time frame: Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit), 21 ± 1 (Safety Call)
Measurement of the Change in Best Near Corrected Visual Acuity (BCNVA)
The change in BCNVA after exposure to investigation product, compared to basal value.
Time frame: Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)
Changes in Intraocular Pressure (IOP)
The change in IOP after exposure to investigation product, compared to basal value.
Time frame: Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)
Number of Cases With Corneal and Conjunctival Staining With Fluorescein
It was graded according to the Sjögren's International Clinical Collaboration Alliance (SICCA) Ocular Staining Score (CTO). According to the CTO, grade 0 corresponds to the absence of punctate epithelial erosions (PEE); grade 1 is defined as the presence of 1-5 EEPs; grade 2 corresponds to 6-30 EEP; and \>30 EEP will be classified as grade 3. Additionally, one qualification point will be added if: 1) EEP is present in the central portion of the cornea with a diameter of 4mm; 2) filaments are observed and 3) confluent staining patches, including linear staining, are observed. A higher score is a worse outcome.
Time frame: Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)
Measurement of Vital Signs (Systolic Blood Pressure)
The change in blood pressure after exposure to investigation product, compared to basal value.
Time frame: Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)
Measurement of Vital Signs (Heart Rate)
The change in heart rate after exposure to investigation product, compared to basal value.
Time frame: Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)
Value of the Ocular Comfort Index (OCI) Questionnaire.
It is a questionnaire designed to measure the irritation of the ocular surface with Rasch analysis to produce estimates on a linear scale of intervals (ratings: 0-100). A higher score is a worse outcome. Similar to the index for ocular surface diseases, the ocular comfort index (OCI) evaluates symptoms. The ICO contains 6 items that focus on the discomfort associated with the ocular surface. Each of these questions has two parts, which inquire separately the frequency and severity of the symptoms. The evaluator will deliver the questionnaire to the subject and allow the subject to answer it calmly without any pressure and / or coercion, will only assist him if he has difficulty understanding any of the questions.
Time frame: Days: 1 (Basal Visit), 16 ± 1 (Final Visit)
Number of Cases With Corneal and Conjunctival Staining With Lissamine Green
It was graded according to the Sjögren's International Clinical Collaboration Alliance (SICCA) Ocular Staining Score (CTO). According to the CTO, grade 0 corresponds to the absence of punctate epithelial erosions (PEE); grade 1 is defined as the presence of 1-5 EEPs; grade 2 corresponds to 6-30 EEP; and \>30 EEP will be classified as grade 3. Additionally, one qualification point will be added if: 1) EEP is present in the central portion of the cornea with a diameter of 4mm; 2) filaments are observed and 3) confluent staining patches, including linear staining, are observed. A higher score is a worse outcome.
Time frame: Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)
| Milestone | PRO-201 |
|---|---|
| Started | 29 |
| Completed | 27 |
| Not completed | 2 |
| Withdrew: Adherence under 90% | 2 |
The number of adverse events presented that are not previously described / known for the active substance in this pharmaceutic form and concentration.
| adverse events | PRO-201 |
|---|---|
| Number of Unexpected Adverse Events | 41 |
The number of cases of photophobia.
| Participants | PRO-201 |
|---|---|
| Basal Visit — Photophobia | 0 |
| Basal Visit — No Photophobia | 29 |
| Visit 1 — Photophobia | 5 |
| Visit 1 — No Photophobia | 24 |
| Final visit — Photophobia | 2 |
| Final visit — No Photophobia | 27 |
Measurement of pupillary diameter after exposure to the investigation product.
| mm | PRO-201 |
|---|---|
| BV pupillary diameter | 3.44 ± 0.44 |
| V1 pupillary diameter | 3.95 ± 0.60 |
| FV pupillary diameter | 3.94 ± 0.52 |
The percentage of adverse events presented that are expected, or previously described / known for the active substance in this pharmaceutic form and concentration.
| percentage | PRO-201 |
|---|---|
| Percentage of Expected Adverse Events | 92.7 |
The change in BCNVA after exposure to investigation product, compared to basal value.
| LogMAR (Snellen Chart) | PRO-201 |
|---|---|
| BV BCNVA | 0.00 ± 0.02 |
| V1 BCNVA | 0.00 ± 0.02 |
| FV BCNVA | 0.01 ± 0.02 |
The change in IOP after exposure to investigation product, compared to basal value.
| mmHg | PRO-201 |
|---|---|
| VB IOP | 14.67 ± 2.67 |
| V1 IOP | 14.04 ± 1.91 |
| FV IOP | 14.02 ± 2.32 |
It was graded according to the Sjögren's International Clinical Collaboration Alliance (SICCA) Ocular Staining Score (CTO). According to the CTO, grade 0 corresponds to the absence of punctate epithelial erosions (PEE); grade 1 is defined as the presence of 1-5 EEPs; grade 2 corresponds to 6-30 EEP; and \>30 EEP will be classified as grade 3. Additionally, one qualification point will be added if: 1) EEP is present in the central portion of the cornea with a diameter of 4mm; 2) filaments are observed and 3) confluent staining patches, including linear staining, are observed. A higher score is a worse outcome.
| Eyes (right) | PRO-201 |
|---|---|
| BV corneal and conjunctival staining with fluorescein : Grade 0 | 27 |
| BV corneal and conjunctival staining with fluorescein : Grade 1 | 0 |
| V1 corneal and conjunctival staining with fluorescein : Grade 0 | 26 |
| V1 corneal and conjunctival staining with fluorescein : Grade 1 | 1 |
| FV corneal and conjunctival staining with fluorescein : Grade 0 | 26 |
| FV corneal and conjunctival staining with fluorescein : Grade 1 | 1 |
The change in blood pressure after exposure to investigation product, compared to basal value.
| mmHg | PRO-201 |
|---|---|
| BV Systolic Blood Pressure | 119.74 ± 8.73 |
| V1 BV Systolic Blood Pressure | 120.96 ± 6.14 |
| FV BV Systolic Blood Pressure | 119.41 ± 7.48 |
The change in heart rate after exposure to investigation product, compared to basal value.
| pulse per minutes | PRO-201 |
|---|---|
| BV Heart Rate | 70.93 ± 6.62 |
| V1 Heart Rate | 73.15 ± 9.51 |
| FV Heart Rate | 74.93 ± 8.11 |
It is a questionnaire designed to measure the irritation of the ocular surface with Rasch analysis to produce estimates on a linear scale of intervals (ratings: 0-100). A higher score is a worse outcome. Similar to the index for ocular surface diseases, the ocular comfort index (OCI) evaluates symptoms. The ICO contains 6 items that focus on the discomfort associated with the ocular surface. Each of these questions has two parts, which inquire separately the frequency and severity of the symptoms. The evaluator will deliver the questionnaire to the subject and allow the subject to answer it calmly without any pressure and / or coercion, will only assist him if he has difficulty understanding any of the questions.
| scores on a scale | PRO-201 |
|---|---|
| BV OCI | 24.93 ± 9.46 |
| FV OCI | 25.05 ± 10.39 |
It was graded according to the Sjögren's International Clinical Collaboration Alliance (SICCA) Ocular Staining Score (CTO). According to the CTO, grade 0 corresponds to the absence of punctate epithelial erosions (PEE); grade 1 is defined as the presence of 1-5 EEPs; grade 2 corresponds to 6-30 EEP; and \>30 EEP will be classified as grade 3. Additionally, one qualification point will be added if: 1) EEP is present in the central portion of the cornea with a diameter of 4mm; 2) filaments are observed and 3) confluent staining patches, including linear staining, are observed. A higher score is a worse outcome.
| Eyes (right) | PRO-201 |
|---|---|
| BV Corneal and conjunctival staining with lissamine green : Grade 0 | 27 |
| BV Corneal and conjunctival staining with lissamine green : Grade 1 | 0 |
| BV Corneal and conjunctival staining with lissamine green : Grade 2 | 0 |
| V1 Corneal and conjunctival staining with lissamine green : Grade 0 | 23 |
| V1 Corneal and conjunctival staining with lissamine green : Grade 1 | 2 |
| V1 Corneal and conjunctival staining with lissamine green : Grade 2 | 2 |
| FV Corneal and conjunctival staining with lissamine green : Grade 0 | 26 |
| FV Corneal and conjunctival staining with lissamine green : Grade 1 | 1 |
| FV Corneal and conjunctival staining with lissamine green : Grade 2 | 0 |
Collected over From day 1 (basal visit) to the safety call on day 21(±2 days). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PRO-201 | 0/29 (0%) | 0/29 (0%) | 21/29 (72.4%) |
| Event | PRO-201 |
|---|---|
| irritation in the area of instillationEye disorders | 10/29 |
| Burning sensationEye disorders | 9/29 |
| Blurred visionEye disorders | 7/29 |
| Ocular hyperemiaEye disorders | 4/29 |
| PruritusEye disorders | 3/29 |
| TearingEye disorders | 3/29 |
| Foreign body sensationEye disorders | 2/29 |
| HeadacheNervous system disorders | 2/29 |
| decreased visual acuityEye disorders | 2/29 |
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
| Age, Categorical(Participants) | PRO-201 |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 29 |
| >=65 years | 0 |
| Age, Continuous(years) | PRO-201 |
|---|---|
| Mean | 22.033 ± 3.61 |
| Sex: Female, Male(Participants) | PRO-201 |
|---|---|
| Female | 19 |
| Male | 10 |
| Race and Ethnicity Not Collected(Participants) | PRO-201 |
|---|
| Region of Enrollment(participants) | PRO-201 |
|---|---|
| Mexico | 29 |
| Intraocular pressure (IOP)(mmhg) | PRO-201 |
|---|---|
| Mean | 14.67 ± 2.67 |
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Laboratorios Sophia S.A de C.V.