Hyperemia EyePhase 1PRO-185NCT05470868
Safety and Tolerability of PRO-185
A Phase 1 study testing Naphazoline / Hypromellose Ophthalmic in people with Hyperemia Eye, run by Laboratorios Sophia S.A de C.V. at 1 site in Mexico.
Trial summary
Phase I Study to evaluate safety and tolerability of PRO-185 (naphazoline/hypromellose) ophthalmic solution through evaluation of vital signs, ocular signs such as intraocular pressure, hyperemia and mydriasis and adverse events. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperemia Eye
- What is being tested?
- Naphazoline / Hypromellose Ophthalmic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteMexico
- Study dates
- 4 Feb 2023to 22 May 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being clinically healthy
- Having the ability to grant a signed informed consent
- Being able and willing to comply with the programmed visits, treatment plan and other procedures of this study.
- Age between 18 and 45 years
- Women in child-bearing age must assure the continuation (start ≥ 30 days previous to the signing of the ICF) of a hormonal contraceptive method or a intrauterine device (IUD) during the period of the study.
- Best corrected visual acuity equal of better than 20/30 in both eyes.
- Vital signs within normal ranges.
- Intraocular pressure ≥10 and ≤ 21 mmHg
Who cannot join
- Using any kind of topic ophthalmic products
- Presenting allergies to naphazoline or the history of intolerance to nasal decongestants or ocular vasoconstrictive products.
- History of diagnosis of suspicion of primary angle closure, primary angle closure or closed angle glaucoma.
- History of iridotomies or waiting for this procedure to take place.
- Conjunctival hyperemia grade 3 or 4 according to Efron scale.
- Ocular surface staining equal or greater to 3 in the SICCA scale, for any eye.
Show all 16Show fewer
- Using medications or herbology products, through any route of administration.
- Pregnant, breastfeeding or women who plan to get pregnant during the period of the study.
- Previous participation in any clinical study 90 days prior to the inclusion in the present study.
- Previous participation in this study.
- Using contact lenses which cannot be suspended during the period of this study.
- History of any chronic illness, including diabetes and hypertension.
- Active inflammation or infection at the time of inclusion in this study.
- Unresolved lesions or traumas at the moment of inclusion in this study.
- History of any kind of ocular surgery.
- History of any surgical procedure, non-ophthalmologic, within the previous 3 months to the inclusion in this study.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
IIMET Investigación e Innovación en Medicina Translacional
Guadalajara, Jalisco, 44650
About this study
Official title: Phase I Clinical Study, to Evaluate the Safety and Tolerability of the Ophthalmic Solution PRO-185 When Applied on the Ocular Surface of Healthy Volunteers
Phase I Study to evaluate safety and tolerability of PRO-185 (naphazoline/hypromellose) ophthalmic solution through evaluation of vital signs, ocular signs such as intraocular pressure, hyperemia and mydriasis and adverse events.
Read the detailed description
A total of 22 healthy volunteers will apply PRO-185 ocular solution on both eyes QID (four times per day) for 8 days. The safety variables will include intraocular pressure, heart rate, systolic and diastolic blood pressure. Tolerability variables will include: hyperemia, mydriasis, and expected and unexpected adverse events. The presence of any of these in ≤ 20% will deem PRO-185 as safe and tolerable.
- Conditions
- Hyperemia Eye
- Being tested
- Naphazoline / Hypromellose Ophthalmic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naphazoline / Hypromellose OphthalmicDrug
Naphazoline 0.03% / Hypromellose 0.2%
| Study group | Role | What they receive |
|---|---|---|
| PRO-185 | Experimental | Healthy volunteers will apply one drop of PRO-185 ophthalmic solution (naphazoline / hypromellose) on both eyes, QID (four times per day) for 8 days. Receives: Drug: Naphazoline / Hypromellose Ophthalmic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure (IOP) Increment
Safety evaluation through the incidence of subjects presenting an IOP elevation comparing Baseline Visit, Final Visit and before and after (20 minutes) research product administration (V1 and V2). Only right-eye values were analyzed.
Measured: Baseline visit (BV), day 1(pre and post pupil dilation); Visit 1 (V1), day 3 +1 (pre and post research product application); Visit 2 (V2), day 8 (pre and post research product application); Final Visit, day 10 (+1)
Heart Rate Increment
Safety evaluation through the incidence of subjects presenting an elevation > 15 beats per minute 20 minutes after administration, in comparison to baseline value.
Measured: Baseline visit, day 1(pre and post pupil dilation); Visit 1, day 3 +1 (pre and post research product application); Visit 2, day 8 (pre and post research product application); Final Visit, day 10 (+1)
Blood Pressure Increment (Systolic)
Safety evaluation through the incidence of subjects presenting an elevation > 15 mmHg in systolic pressure or > 10 mmHg in diastolic pressure 20 minutes after administration, in comparison to baseline value.
Measured: Baseline visit, day 1(pre and post pupil dilation); Visit 1, day 3 +1 (pre and post research product application); Visit 2, day 8 (pre and post research product application); Final Visit, day 10 (+1)
Incidence of Conjunctival Hyperemia
Tolerability evaluation through the incidence of conjunctival hyperemia grades 3 and 4 (according to the Efron scale). A higher score (grades) in this scale translates into worse outcomes. Only right-eye values were analyzed.
Measured: Trough Day 10 (+1)
Incidence of Pharmacological Mydriasis
Incidence of pharmacological mydriasis measured through OPD III scan. If there was a change greater than 2 mm in pupil diameter between the baseline visit and any of the other measurements, pharmacological mydriasis was considered present, also if there was this change between the pre- and post-examination of the investigational product during visits 1 and 2.
Measured: Trough Day 10 (+1)
Blood Pressure Increment (Diastolic)
Safety evaluation through the incidence of subjects presenting an elevation > 15 mmHg in systolic pressure or > 10 mmHg in diastolic pressure 20 minutes after administration, in comparison to baseline value.
Measured: Baseline visit, day 1(pre and post pupil dilation); Visit 1, day 3 +1 (pre and post research product application); Visit 2, day 8 (pre and post research product application); Final Visit, day 10 (+1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start4 Feb 2023
- Primary completion22 May 2023
- Study completion22 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hyperemia EyeStudies 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, controlled, non-comparative, single-center, open study.
- Masking
- None (open label)
- Enrolment
- 22 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
- NCT05470868
- Sponsor's protocol ID
- SOPH185-0521/I
- Acronym
- PRO-185
- Status last verified
- Jul 2025
- First submitted
- 23 Mar 2022
- Last updated
- 17 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study, to Evaluate the Safety and Tolerability of the Ophthalmic Solution PRO-185 When Applied on the Ocular Surface of Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05470868
- Acronym / sponsor ID
- PRO-185 / SOPH185-0521/I
- Conditions
- Hyperemia Eye
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Laboratorios Sophia S.A de C.V.Industry (pharma, biotech, devices)
- Study start
- 4 Feb 2023 (actual)
- Primary completion
- 22 May 2023 (actual)
- Study completion
- 22 May 2023 (actual)
- First posted
- 22 Jul 2022 (actual)
- Results
- Posted 17 Jul 2025
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-185 (naphazoline/hypromellose) ophthalmic solution through evaluation of vital signs, ocular signs such as intraocular pressure, hyperemia and mydriasis and adverse events.
Detailed description
A total of 22 healthy volunteers will apply PRO-185 ocular solution on both eyes QID (four times per day) for 8 days. The safety variables will include intraocular pressure, heart rate, systolic and diastolic blood pressure. Tolerability variables will include: hyperemia, mydriasis, and expected and unexpected adverse events. The presence of any of these in ≤ 20% will deem PRO-185 as safe and 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, controlled, non-comparative, single-center, open study.
| Arm | Type | Receives |
|---|---|---|
| PRO-185 | Experimental | Drug: Naphazoline / Hypromellose OphthalmicHealthy volunteers will apply one drop of PRO-185 ophthalmic solution (naphazoline / hypromellose) on both eyes, QID (four times per day) for 8 days. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Being clinically healthy
- Having the ability to grant a signed informed consent
- Being able and willing to comply with the programmed visits, treatment plan and other procedures of this study.
- Age between 18 and 45 years
- Women in child-bearing age must assure the continuation (start ≥ 30 days previous to the signing of the ICF) of a hormonal contraceptive method or a intrauterine device (IUD) during the period of the study.
Key exclusion criteria (16 listed)
- Using any kind of topic ophthalmic products
- Presenting allergies to naphazoline or the history of intolerance to nasal decongestants or ocular vasoconstrictive products.
- History of diagnosis of suspicion of primary angle closure, primary angle closure or closed angle glaucoma.
- History of iridotomies or waiting for this procedure to take place.
- Conjunctival hyperemia grade 3 or 4 according to Efron scale.
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 |
|---|---|---|
| Naphazoline / Hypromellose OphthalmicNaphazoline 0.03% / Hypromellose 0.2% | Drug | PRO-185 |
Primary outcome
Intraocular Pressure (IOP) Increment
Time frame: Baseline visit (BV), day 1(pre and post pupil dilation); Visit 1 (V1), day 3 +1 (pre and post research product application); Visit 2 (V2), day 8 (pre and post research product application); Final Visit, day 10 (+1)
Safety evaluation through the incidence of subjects presenting an IOP elevation comparing Baseline Visit, Final Visit and before and after (20 minutes) research product administration (V1 and V2). Only right-eye values were analyzed.
Heart Rate Increment
Time frame: Baseline visit, day 1(pre and post pupil dilation); Visit 1, day 3 +1 (pre and post research product application); Visit 2, day 8 (pre and post research product application); Final Visit, day 10 (+1)
Safety evaluation through the incidence of subjects presenting an elevation > 15 beats per minute 20 minutes after administration, in comparison to baseline value.
Blood Pressure Increment (Systolic)
Time frame: Baseline visit, day 1(pre and post pupil dilation); Visit 1, day 3 +1 (pre and post research product application); Visit 2, day 8 (pre and post research product application); Final Visit, day 10 (+1)
Safety evaluation through the incidence of subjects presenting an elevation > 15 mmHg in systolic pressure or > 10 mmHg in diastolic pressure 20 minutes after administration, in comparison to baseline value.
Incidence of Conjunctival Hyperemia
Time frame: Trough Day 10 (+1)
Tolerability evaluation through the incidence of conjunctival hyperemia grades 3 and 4 (according to the Efron scale). A higher score (grades) in this scale translates into worse outcomes. Only right-eye values were analyzed.
Incidence of Pharmacological Mydriasis
Time frame: Trough Day 10 (+1)
Incidence of pharmacological mydriasis measured through OPD III scan. If there was a change greater than 2 mm in pupil diameter between the baseline visit and any of the other measurements, pharmacological mydriasis was considered present, also if there was this change between the pre- and post-examination of the investigational product during visits 1 and 2.
Blood Pressure Increment (Diastolic)
Time frame: Baseline visit, day 1(pre and post pupil dilation); Visit 1, day 3 +1 (pre and post research product application); Visit 2, day 8 (pre and post research product application); Final Visit, day 10 (+1)
Safety evaluation through the incidence of subjects presenting an elevation > 15 mmHg in systolic pressure or > 10 mmHg in diastolic pressure 20 minutes after administration, in comparison to baseline value.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Naphazoline / Hypromellose Ophthalmic in people with Hyperemia Eye, run by Laboratorios Sophia S.A de C.V. at 1 site in Mexico.
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 8 inclusion and 16 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: finished, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 17 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Intraocular Pressure (IOP) Increment (time frame: Baseline visit (BV), day 1(pre and post pupil dilation); Visit 1 (V1), day 3 +1 (pre and post research product application); Visit 2 (V2), day 8 (pre and post research product application); Final Visit, day 10 (+1)). The study lists 6 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 17 Jul 2025.