HealthyPhase 1NCT01871077

Safety and Tolerability of the Ophthalmic Solution PRO-156 in Ophthalmologically Healthy Volunteers.

A Phase 1 study testing PRO-156 in people with Healthy, run by Laboratorios Sophia S.A de C.V..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to evaluate safety and tolerability of the ophthalmic solution PRO-156 over the ocular surface of ophthalmologically healthy volunteers Read more about this study

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: PRO-156
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: No sites listed yet
Study dates: Sep 2013to Dec 2013
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 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male and female.
Age between 18 and 40 years old at screening visit.
Signed informed consent

Who cannot join

Patient with one blind eye.
Any ocular or systemic condition.
Visual acuity of 20/100 in any eye.
Use of ocular or systemic medication.
Contraindications or sensitivity to any component of the study treatment.
Contact lens users.

Show all 9Show fewer

Ocular surgery within the past 3 months..
Pregnant, nursing or childbearing potential women who were not using effective contraception.
Participation in any studies of investigational drugs within 90 days previous to the inclusion.

About this study

Official title: Phase I Clinical Trial to Assess the Safety and Tolerability of the Ophthalmic Solution PRO-156 Over the Ocular Surface of Ophthalmologically Healthy Volunteers.

The purpose of this study is to evaluate safety and tolerability of the ophthalmic solution PRO-156 over the ocular surface of ophthalmologically healthy volunteers

Read the detailed description

A phase I, open label and unicentric clinical trial to evaluate the safety and tolerability of the ophthalmic solution PRO-143 over the ocular surface of ophthalmologically healthy volunteers.

Conditions: Healthy
Being tested: PRO-156

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PRO-156Drug
Also called Ketorolac
Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days.

Study groups in NCT01871077
Study group	Role	What they receive
PRO-156	Experimental	Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days. Receives: Drug: PRO-156

What is being measured

The primary outcome is the main question the study is designed to answer.

Visual Acuity (VA)
The VA will be evaluated basally, without refractive correction with the Snellen chart. A Snellen chart is placed at a standard distance: 20 ft. At this distance, the symbols on the line representing "normal" acuity subtend. This line, designated 20/20 is the smallest line that a person with normal acuity can read at a distance of 20fs. the scale consists of 11 lines of letters of different size, the size of the letter gives a fractional value according to the visual acuity of the patient, the value is inversely proportional to the visual acuity, if the denominator is greater the visual acuity will be less.
Line 1: 20/200 Line 2: 20/100, Line 3: 20/70, line 4: 20/50, line 5: 20/40, Line 6: 20/30, line 7: 20/25, Line 8: 20/20, line 9: 20/15, line 10: 20/13, line 11: 20/10.
the results will be expressed as the mean of the denominator of the Snellen scale (scale 20/--) example. 18.5 ± 1.5, that means the final result is 20/18.5 ± 1.5
Measured: 11 days

Secondary outcomes (3)

Intraocular Pressure (IOP)
The tension of a healthy eye should be between 10 and 20 millimeters of mercury (mmHg). In Goldman-type Applying Tonometry, the cornea is flattened, and the intraocular pressure is determined by measuring the force of application and the flattened area.
Measured: 11 days
Number of Eyes With Epithelial Defects
the number of epithelial defects was evaluated by the application of fluorescein, Staining was performed with fluorescein which stained the degenerated cells and the mucus filaments present in the tear film.
Measured: 11 days
Number of Cases With Adverse Events
The presence of adverse events was evaluated by the number of cases.
Measured: 11 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2013Dec 2013

First posted6 Jun 2013 (estimated)
Study startSep 2013
Primary completionDec 2013
Study completionDec 2013

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 HealthyStudies 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: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01871077
Sponsor's protocol ID: SOPH156-0612/I
Status last verified: Oct 2019
First submitted: 4 Jun 2013
Last updated: 25 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Clinical Trial to Assess the Safety and Tolerability of the Ophthalmic Solution PRO-156 Over the Ocular Surface of Ophthalmologically Healthy Volunteers.
ClinicalTrials.gov ID: NCT01871077
Acronym / sponsor ID: SOPH156-0612/I
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Laboratorios Sophia S.A de C.V.Industry (pharma, biotech, devices)
Study start: Sep 2013
Primary completion: Dec 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 6 Jun 2013 (estimated)
Results: Posted 25 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate safety and tolerability of the ophthalmic solution PRO-156 over the ocular surface of ophthalmologically healthy volunteers

Detailed description

A phase I, open label and unicentric clinical trial to evaluate the safety and tolerability of the ophthalmic solution PRO-143 over the ocular surface of ophthalmologically 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-156	Experimental	Drug: PRO-156Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days.

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Healthy male and female.
Age between 18 and 40 years old at screening visit.
Signed informed consent

Key exclusion criteria (9 listed)

Patient with one blind eye.
Any ocular or systemic condition.
Visual acuity of 20/100 in any eye.
Use of ocular or systemic medication.
Contraindications or sensitivity to any component of the study treatment.

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-156Also: KetorolacDrug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days.	Drug	PRO-156

Primary outcome

Visual Acuity (VA)
Time frame: 11 days
The VA will be evaluated basally, without refractive correction with the Snellen chart. A Snellen chart is placed at a standard distance: 20 ft. At this distance, the symbols on the line representing "normal" acuity subtend. This line, designated 20/20 is the smallest line that a person with normal acuity can read at a distance of 20fs. the scale consists of 11 lines of letters of different size, the size of the letter gives a fractional value according to the visual acuity of the patient, the value is inversely proportional to the visual acuity, if the denominator is greater the visual acuity will be less. Line 1: 20/200 Line 2: 20/100, Line 3: 20/70, line 4: 20/50, line 5: 20/40, Line 6: 20/30, line 7: 20/25, Line 8: 20/20, line 9: 20/15, line 10: 20/13, line 11: 20/10. the results will be expressed as the mean of the denominator of the Snellen scale (scale 20/--) example. 18.5 ± 1.5, that means the final result is 20/18.5 ± 1.5

3 secondary outcomes

Intraocular Pressure (IOP)
Time frame: 11 days
Number of Eyes With Epithelial Defects
Time frame: 11 days
Number of Cases With Adverse Events
Time frame: 11 days

Results and safety

Results posted to the registry on 25 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PRO-156	30	30

Primary outcome: Visual Acuity (VA)

Time frame: 11 days. Mean (Standard Deviation). Unit: score on a scale

Measure	PRO-156 n = 30
basal visit	19.9 (1.2)
Final visit	19.83 (0.9)

PRO-156: p = 0.890, Friedman test

Population analysed: the analysis by treatment of the research subjects was carried out

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: The evaluation period was throughout the study (13 days) comprising 11 days of intervention plus 2 days of safety call. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PRO-156	0 of 30 (0%)	6 of 30 (20%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Mauricio Casillas, MD principal investigator

Independent Clinical Research Center

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PRO-156 in people with Healthy, 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 3 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: finished, as of the sponsor's last update on 25 Oct 2019. 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?

Yes. Results are posted in the registry (first posted 25 Oct 2019). 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?

Visual Acuity (VA) (time frame: 11 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01871077.

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 25 Oct 2019.