Conjunctivitis, BacterialPhase 1PRO-143NCT03698045
Safety and Tolerability of PRO-143 Ophthalmic Solution in Healthy Volunteers.
A Phase 1 study testing PRO-143 Ophthalmic Solution in people with Conjunctivitis, Bacterial, run by Laboratorios Sophia S.A de C.V. at 1 site in Mexico.
Trial summary
Study to evaluate the safety and tolerability of PRO-143 solution ophthalmic in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Conjunctivitis, Bacterial
- What is being tested?
- PRO-143 Ophthalmic Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteMexico
- Study dates
- Nov 2013to Mar 2014
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male and female.
- Age ≥ 18 years old at screening visit.
Who cannot join
- Any ocular or systemic condition.
- Patient with one blind eye.
- Visual acuity of 20/40 in any eye.
- Use of ocular or systemics medications.
- Contraindications or sensitivity to any component of the study treatments.
- Contact lens users.
Show all 9Show fewer
- Ocular surgery within the past 3 months..
- Women who were not using an effective means of contraception or who were pregnant or nursing.
- Participation in any studies of investigational drugs within 90 days previous to the inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study to Evaluate the Safety and Tolerability of Pro-143 Ophthalmic Solution in Healthy Volunteers.
Study to evaluate the safety and tolerability of PRO-143 solution ophthalmic in healthy volunteers.
Read the detailed description
A phase I, open label and unicentric clinical trial to evaluate the safety and tolerability of PRO-143 ophthalmic solution in healthy volunteers.
- Conditions
- Conjunctivitis, Bacterial
- Being tested
- PRO-143 Ophthalmic Solution
- Keywords
- PRO-143, Topical antibiotic, Ophthalmic antibiotic, External bacterial infections
- Medical subject headings
- Conjunctivitis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRO-143 Ophthalmic SolutionDrug
Also called PRO-143
PRO-143 Ophthalmic Solution applied four times per day (C/6 hours) during 10 days.
| Study group | Role | What they receive |
|---|---|---|
| PRO-143 Ophthalmic Solution | Experimental | PRO-143 Ophthalmic Solution applied four times per day (c/6 hours) during 10 days. Receives: Drug: PRO-143 Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conjunctival bulbar hyperemia
Conjunctival hyperemia is defined as the simplest reaction of the conjunctiva to a stimulus, a red appearance secondary to the vasodilation of the conjunctival vessels of variable intensity. He will graduate using the Efron scale.
0 Normal , 1 Very slight, 2 Mild, 3 Moderate, 4 Severe.
Measured: 10 days
Number of Participants with adverse events
he evaluation of adverse events requires a questioning conducted by the principal investigator and the appropriate exploratory techniques for its detection. the number of adverse events per study group will be considered for the analysis
Measured: 10 days
Secondary outcomes (3)
Intraocular pressure (IOP)
Tonometry is the objective measure of Intraocular pressure, based primarily on the force required to flatten the cornea, or the degree of corneal indentation produced by a fixed force. Goldman's tonometry is based on the Imbert-Fick principle. the result will be expressed in millimeters of mercury and the comparison between groups will be carried out.
Measured: 10 days
Visual ability (VA)
The VA will be evaluated basally, without refractive correction with the Snellen chart. Which will be located in a place with adequate lighting, natural or artificial and at a distance of 3 meters from the subject to be evaluated
Measured: 10 days
Eye comfort index (ICO)
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). Similar to the index for ocular surface diseases, the ocular comfort index (ICO) 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.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study startNov 2013
- Primary completionFeb 2014 (estimated)
- Study completionMar 2014 (estimated)
Why it stopped: the clinical study was canceled by the sponsor due to logistics and programming
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conjunctivitis, BacterialStudies 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
- 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
- Investigators
- José F Alaniz-De La O, MD, Principal investigator, Independent Clinical Research CenterLaura R Saucedo-Rodíguez, MD, Principal investigator, Independent Clinical Research CenterLeopoldo M Baiza-Durán, MD, Study director, Clinical Research Department. Laboratorios Sophia SA de CV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03698045
- Sponsor's protocol ID
- SOPH143-0212/I
- Other IDs
- PRO-143
- Acronym
- PRO-143
- Status last verified
- Oct 2018
- First submitted
- 22 Feb 2012
- Last updated
- 10 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Safety and Tolerability of Pro-143 Ophthalmic Solution in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT03698045
- Acronym / sponsor ID
- PRO-143 / SOPH143-0212/I
- Conditions
- Conjunctivitis, Bacterial
- Keywords
- PRO-143, Topical antibiotic, Ophthalmic antibiotic, External bacterial infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: the clinical study was canceled by the sponsor due to logistics and programming
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Laboratorios Sophia S.A de C.V.Industry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 5 Oct 2018 (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.
Study to evaluate the safety and tolerability of PRO-143 solution ophthalmic in healthy volunteers.
Detailed description
A phase I, open label and unicentric clinical trial to evaluate the safety and tolerability of PRO-143 ophthalmic solution in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRO-143 Ophthalmic Solution | Experimental | Drug: PRO-143 Ophthalmic SolutionPRO-143 Ophthalmic Solution applied four times per day (c/6 hours) during 10 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy male and female.
- Age ≥ 18 years old at screening visit.
Key exclusion criteria (9 listed)
- Any ocular or systemic condition.
- Patient with one blind eye.
- Visual acuity of 20/40 in any eye.
- Use of ocular or systemics medications.
- Contraindications or sensitivity to any component of the study treatments.
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 |
|---|---|---|
| PRO-143 Ophthalmic SolutionAlso: PRO-143PRO-143 Ophthalmic Solution applied four times per day (C/6 hours) during 10 days. | Drug | PRO-143 Ophthalmic Solution |
Primary outcome
Conjunctival bulbar hyperemia
Time frame: 10 days
Conjunctival hyperemia is defined as the simplest reaction of the conjunctiva to a stimulus, a red appearance secondary to the vasodilation of the conjunctival vessels of variable intensity. He will graduate using the Efron scale. 0 Normal , 1 Very slight, 2 Mild, 3 Moderate, 4 Severe.
Number of Participants with adverse events
Time frame: 10 days
he evaluation of adverse events requires a questioning conducted by the principal investigator and the appropriate exploratory techniques for its detection. the number of adverse events per study group will be considered for the analysis
3 secondary outcomes
Intraocular pressure (IOP)
Time frame: 10 days
Visual ability (VA)
Time frame: 10 days
Eye comfort index (ICO)
Time frame: 10 days
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 10 Oct 2018.
Related trials for Conjunctivitis, Bacterial
Not yet recruitingPhase 4
Evaluation of the Impact of Oral Ivermectin on Musca Sorbens Flies, Putative Vector of Trachoma
Survival of Flies Developing in Faecal Samples
RecruitingPhase 1/2
Safety and Efficacy of SUM-191 for Patients With Bacterial Conjunctivitis
Bacterial Conjunctivitis
RecruitingObservational study
Development of a Mobile Terminal-Based Intelligent Detection System for Multiple Anterior Segment Diseases of the Eye
Artifical Intelligence, Cataract
RecruitingObservational study
Proteomic and Metabolomic Lacrimal Fingerprint in Diverse Pathologies of the Ocular Surface
Dry Eye Syndrome, Infectious Keratoconjunctivitis
Recruiting
RESTORE: Comparing Two Approaches to Repeat TT Surgery Performed by Integrated Eye Care Workers (IECWs)
Trachoma, Eye Diseases
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.
José F Alaniz-De La O, MD principal investigator
Independent Clinical Research Center
Laura R Saucedo-Rodíguez, MD principal investigator
Independent Clinical Research Center
Leopoldo M Baiza-Durán, MD study director
Clinical Research Department. Laboratorios Sophia SA de CV
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 PRO-143 Ophthalmic Solution in people with Conjunctivitis, Bacterial, 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 2 inclusion and 9 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 10 Oct 2018. 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?
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?
Conjunctival bulbar hyperemia (time frame: 10 days). 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 10 Oct 2018.