Dry Eye SyndromePhase 4087LATAMFIVNCT03223909
Efficacy and Safety of the Ophthalmic Solution PRO-087 Versus Systane ® Ultra and Ultra Preservative Free (087LATAMFIV)
A Phase 4 study testing PRO-087, Systane Ultra and Systane Ultra Preservative Free in people with Dry Eye Syndrome, run by Laboratorios Sophia S.A de C.V. at 1 site in Mexico.
Trial summary
Efficacy and Safety of the Ophthalmic Solution PRO-087 versus Systane ® Ultra and Systane ® Ultra Preservative Free on the Tear Film Dysfunction Syndrome from Mild to Moderate Clinical trial To evaluate the effectiveness of preservative-free ophthalmic formulation PRO-087 (by Laboratorios Sophia, S.A. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dry Eye Syndrome
- What is being tested?
- PRO-087, Systane Ultra and Systane Ultra Preservative Free
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 326 participants
- Where
- 1 siteMexico
- Study dates
- 13 Oct 2016to 16 Dec 2018
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 to < 90 years old
- Both sexes
- Mild to moderate tear film dysfunction clinical diagnose
- Mild to moderate clinical stage of the disease
- TBUT > 5 sec. and < 10 sec.
- Schirmer: > 4 mm and < 14 mm
Show all 9Show fewer
- OSDI < 30 points
- Corneal staining < grade III on the Oxford scale
- Availability to go to each revision when indicated.
Who cannot join
- General Criteria
- Subjects with topical and/or systemic medication or mechanical devices that interfere determinedly on the results of the study (such as topical immunomodulators, punctal plugs, corticosteroids, preservative artificial tears, contact lenses).
- Subjects (females) with active sexual life that do not use a contraceptive method.
- Female subjects who are pregnant or lactating
- Female subjects with a positive urine pregnancy test
- Positive drug addictions* (verbal interrogatory)
Show all 27Show fewer
- Subjects who have participated on any other research clinical trials on the last 40 days
- Subjects legal or mentally disabled to give an informed consent for participating on this study
- Subjects who can't comply with the appointments or with every protocol requirement.
- Criteria related with ophthalmic ailments
- Serious tear film dysfunction syndrome TBUT < 5 s Schirmer: < 4 mm OSDI > 30 pints Corneal staining > grade III on the Oxford scale
- Non perforated corneal ulcer
- Perforated corneal ulcer
- Autoimmune corneal ulcer
- Ocular surface scarring diseases
- Ocular surface or annexes metaplastic lesions
- Fibro vascular proliferation lesions on the conjunctival and/or corneal surface (i.e.: pterygium)
- Concomitant chronic inflammatory diseases on any ocular structure
- Acute or infectious inflammatory disease
- Corneal disease potentially requiring a treatment during the following 3 months
- Use of topical or systemic drug products classified as forbidden
- Ocular surgical procedures 3 months before the protocol inclusion
- Treatments or procedures indicated on the tear film dysfunction treatment, as punctal silicone plugs.
- Posterior segment diseases requiring a treatment or threatening the visual prognosis
- Retinal diseases potentially requiring treatment during the following 3 months
- History of penetrating keratoplasty.
- Soft or hard contact lenses use during the last month from inclusion day
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of the Ophthalmic Solution PRO-087 Versus Systane ® Ultra and Systane ® Ultra Preservative Free on Tear Film Dysfunction Syndrome From Mild to Moderate
Efficacy and Safety of the Ophthalmic Solution PRO-087 versus Systane ® Ultra and Systane ® Ultra Preservative Free on the Tear Film Dysfunction Syndrome from Mild to Moderate Clinical trial To evaluate the effectiveness of preservative-free ophthalmic formulation PRO-087 (by Laboratorios Sophia, S.A. de C.V.) to restore the anatomical and physiological characteristics of the ocular surface, as well as its distribution and the characteristics of the mild to moderate tear film dysfunction syndrome compared to Systane ® Ultra and Ultra Systane ® preservative free (by Laboratorios Alcon, S.A. de C.V.).
Controlled, randomized, double-blind, masked clinical study, comparing the safety and efficacy of preservative-free PR0-087 vs Systane Ultra with preservative and Systane Ultra preservative free, in subjects with mild to moderate tear film dysfunction syndrome, for a period of 90 days plus 15 days of remote surveillance, in which one of the three agents will be administered (PR0-087, Systane® Ultra or Systane® Ultra preservative free) with a q.i.d. dosage. in both eyes, with regular follow-up visits (5 overall).
Best-corrected visual acuity Intraocular pressure Ocular surface Anterior segment examination Posterior segment examination Tear film break-up time Schirmer test Corneal epithelization Goblet cells count Adverse events Subjects with a clinical diagnosis of mild to moderate tear film dysfunction syndrome between 18 and 90 years old, without concomitant eye diseases nor requiring different treatments of any of the three interventions in this study They will be randomized in 3 groups where PRO-087, Systane® Ultra o Systane® Ultra preservative free will be administered.
Read the detailed description
Design Controlled, double-blind, randomized, clinical trial comparing the safety and efficacy parameters between a group of subjects with a diagnose of mild to moderate tear film dysfunction syndrome under a regimen of ophthalmic solution lubricant drops PRO-087 versus subject under Systane® Ultra or Systane® Ultra preservative free, with the same diagnosis, with a follow-up of 90 days
MAIN OBJECTIVE:
To evaluate the effectiveness of preservative-free ophthalmic formulation PRO-087 (by Laboratorios Sophia, S.A. de C.V.) to restore the anatomical and physiological characteristics of the ocular surface, as well as its distribution and the characteristics of the mild to moderate tear film dysfunction syndrome compared to Systane ® Ultra and Ultra Systane ® preservative free (by Laboratorios Alcon, S.A. de C.V.).
SPECIFIC OBJECTIVES:
To evaluate the safety of the preservative-free ophthalmic formulation PRO-087 (by Laboratorios Sophia, S.A. de C.V.) on the corneal and conjunctival epithelium, intraocular pressure, and structures of anterior and posterior segment in patients with tear film dysfunction syndrome from mild to moderate.
To determine the correlation between improvement of clinical status and perceived improvement of symptoms of each participant in each study group.
To compare the qualitative and quantitative histological status of the ocular surface before and after the pharmacological intervention in each study group to determine the evolution under the intervention of PRO-087.
To evaluate the quantitative rating of tear film production by the Schirmer Test throughout the study.
To qualitatively assess the tear film production by measuring the tear film break-up time stained with fluorescein and cobalt filter.
Blinding:
The double-blind study is a procedure in which the patient and the treating doctor ignore to which intervention group the study patient was assigned. To achieve the blinding of both the drug in research and both comparator drugs, these will be labeled in the same way (masking). Besides the figure of an unblinded pharmacist, who is responsible for the delivery of the medication to the patient, will be added. Blinding codes are protected by an outsider appointed by the study sponsor. The codes are also available in the research center (fully sealed), so that they can be consulted by the investigator in case a subject presents a serious adverse event, prior authorization from the study sponsor; the blinding also continues rigorous during the data analysis and interpretation.
patients with tear film dysfunction, classified as mild to moderate, will be included and randomized into 3 groups; the first being treated with PRO-087 ophthalmic solution, the second with Systane® Ultra ophthalmic solution, and the third with ophthalmic solution Systane® Ultra preservative free.
Pharmacological Intervention
The pharmacological intervention will be the instillation of the ophthalmic solution in the bottom of the conjunctival sac during the waking period, in any of the following study groups:
- Preservative free PRO-087 ophthalmic solution. Dropper bottle. Multidose 1 drop every 4 hours for 90 days.
- Systane® Ultra ophthalmic solution. Dropper bottle. Multidose. 1 drop every 4 hours for 90 days.
- Systane ® Ultra preservative free ophthalmic solution. Single-use vials. 1 drop every 4 hours for 90 days.
- Conditions
- Dry Eye Syndrome
- Being tested
- PRO-087, Systane Ultra, Systane Ultra Preservative Free
- Keywords
- dry eye, Chondroitin sulfate, Ocular lubricants
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRO-087Drug
Also called Chondroitin sulfate, sodium hyaluronate
0.1% sodium hyaluronate, free-preservative 0.18% chondroitin sulphate
Systane UltraDrug
Also called polyethylene glycol 400, propylene glycol
Is a sterile solution containing polyethylene glycol 400, propylene glycol, hydroxypropyl-guar, sorbitol, aminomethylpropanol, boric acid, potassium chloride, sodium chloride and POLYQUAD® (poly-hydronium chloride) 0.001% as preservative.
Systane Ultra Preservative FreeDrug
Also called Polyethylene Glycol 400 0.4%, Propylene Glycol 0.3%
Polyethylene Glycol 400 0.4%Lubricant, Propylene Glycol 0.3% Lubricant,
| Study group | Role | What they receive |
|---|---|---|
| PRO-087 PF | Experimental | Preservative free (PF) PRO-087 ophthalmic solution. Dropper bottle. Multidose 1 drop every 4 hours for 90 days. Receives: Drug: PRO-087 |
| Systane Ultra | Active comparator | Systane Ultra ophthalmic solution, Dropper bottle, Multidose.
1 drop every 4 hours for 90 days. Receives: Drug: Systane Ultra |
| Systane Ultra PF | Active comparator | Systane Ultra, preservative free ophthalmic solution, single-use vials.
1 drop every 4 hours for 90 days. Receives: Drug: Systane Ultra Preservative Free |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
Best-corrected visual acuity
Measured: Change from Baseline visual acuity at 90 days
Secondary outcomes (7)
Corneal Epithelization Defects With Rose of Bengal
Percentage of the damaged epithelium of the ocular surface, reduction of staining according to the oxford scale.
Measured: Final Visit (day 90)
Tear Film Break-up Time (TBUT)
Tear breakup time (TBUT) is a clinical test used to assess for evaporative dry eye disease. To measure TBUT, fluorescein is instilled into the patient's tear film and the patient is asked not to blink while the tear film is observed under a broad beam of cobalt blue illumination. The TBUT is recorded as the number of seconds that elapse between the last blink and the appearance of the first dry spot in the tear film, as seen in this progression of these slit lamps photos over time. A TBUT under 10 seconds is considered abnormal
Measured: Base line and Final Visit (day 90)
Schirmer Test
Schirmer's test determines whether the eye produces enough tears to keep it moist. This test is used when a person experiences very dry eyes or excessive watering of the eyes. It poses no risk to the subject. A negative (more than 10 mm of moisture on the filter paper in 5 minutes) test result is normal. Both eyes normally secrete the same amount of tears.
Measured: Base line and Final Visit (day 90)
Adverse Events
Presence of adverse events modifying some of the abovementioned criteria or others, evaluated as serious.
Measured: 90 days
Ocular Surface Disease Index (OSDI)
The OSDI, which was created to order to quickly assess the symptoms of ocular irritation in dry eye disease and how they affect functioning related to vision. This 12-item questionnaire assesses dry eye symptoms and the effects it has on vision-related function in the past of the patient's life. The questionnaire has 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patients rate their responses on a 0 to 4 scale with 0 corresponding to "none of the time" and 4 corresponding to "all of the time." A final score is calculated which ranges from 0 to 100 with scores 0 to 12 representing normal, 13 to 22 representing mild dry eye disease, 23 to 32 representing moderate dry eye disease, and greater than 33 representing severe dry eye disease.
Measured: Change from Baseline OSDI at 90 days
Goblet Cells Population
Increase of 20% from baseline
Measured: Change from Baseline Goblet cells population at 90 days
Corneal Epithelization Defects With Fluorescein
Percentage of the damaged epithelium of the ocular surface, reduction of staining according to the oxford scale.
Measured: Final Visit (day 90)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start13 Oct 2016
- Primary completion16 Oct 2018
- Study completion16 Dec 2018
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 Dry Eye SyndromeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Controlled, double-blind, randomized, clinical trial comparing the safety and efficacy parameters between a group of subjects with a diagnose of mild to moderate tear film dysfunction syndrome under a regimen of ophthalmic solution lubricant drops PRO-087 versus subject under Systane® Ultra or Systane® Ultra preservative free, with the same diagnosis, with a follow-up of 90 days.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Sophia S.A de C.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leopoldo Baiza, MD, Study director, Laboratorios Sophia S.A de C.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03223909
- Sponsor's protocol ID
- SOPH087-0415/IV
- Acronym
- 087LATAMFIV
- Status last verified
- Oct 2019
- First submitted
- 22 Jun 2017
- Last updated
- 31 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For security and laws implemented by the regulatory entity can not share personal data of research subjects.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of the Ophthalmic Solution PRO-087 Versus Systane ® Ultra and Systane ® Ultra Preservative Free on Tear Film Dysfunction Syndrome From Mild to Moderate
- ClinicalTrials.gov ID
- NCT03223909
- Acronym / sponsor ID
- 087LATAMFIV / SOPH087-0415/IV
- Conditions
- Dry Eye Syndrome
- Keywords
- dry eye, Chondroitin sulfate, Ocular lubricants
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- Laboratorios Sophia S.A de C.V.Industry (pharma, biotech, devices)
- Study start
- 13 Oct 2016 (actual)
- Primary completion
- 16 Oct 2018 (actual)
- Study completion
- 16 Dec 2018 (actual)
- First posted
- 21 Jul 2017 (actual)
- Results
- Posted 31 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Efficacy and Safety of the Ophthalmic Solution PRO-087 versus Systane ® Ultra and Systane ® Ultra Preservative Free on the Tear Film Dysfunction Syndrome from Mild to Moderate Clinical trial To evaluate the effectiveness of preservative-free ophthalmic formulation PRO-087 (by Laboratorios Sophia, S.A. de C.V.) to restore the anatomical and physiological characteristics of the ocular surface, as well as its distribution and the characteristics of the mild to moderate tear film dysfunction syndrome compared to Systane ® Ultra and Ultra Systane ® preservative free (by Laboratorios Alcon, S.A. de C.V.).
Controlled, randomized, double-blind, masked clinical study, comparing the safety and efficacy of preservative-free PR0-087 vs Systane Ultra with preservative and Systane Ultra preservative free, in subjects with mild to moderate tear film dysfunction syndrome, for a period of 90 days plus 15 days of remote surveillance, in which one of the three agents will be administered (PR0-087, Systane® Ultra or Systane® Ultra preservative free) with a q.i.d. dosage. in both eyes, with regular follow-up visits (5 overall).
Best-corrected visual acuity Intraocular pressure Ocular surface Anterior segment examination Posterior segment examination Tear film break-up time Schirmer test Corneal epithelization Goblet cells count Adverse events Subjects with a clinical diagnosis of mild to moderate tear film dysfunction syndrome between 18 and 90 years old, without concomitant eye diseases nor requiring different treatments of any of the three interventions in this study They will be randomized in 3 groups where PRO-087, Systane® Ultra o Systane® Ultra preservative free will be administered.
Detailed description
Design Controlled, double-blind, randomized, clinical trial comparing the safety and efficacy parameters between a group of subjects with a diagnose of mild to moderate tear film dysfunction syndrome under a regimen of ophthalmic solution lubricant drops PRO-087 versus subject under Systane® Ultra or Systane® Ultra preservative free, with the same diagnosis, with a follow-up of 90 days
MAIN OBJECTIVE:
To evaluate the effectiveness of preservative-free ophthalmic formulation PRO-087 (by Laboratorios Sophia, S.A. de C.V.) to restore the anatomical and physiological characteristics of the ocular surface, as well as its distribution and the characteristics of the mild to moderate tear film dysfunction syndrome compared to Systane ® Ultra and Ultra Systane ® preservative free (by Laboratorios Alcon, S.A. de C.V.).
SPECIFIC OBJECTIVES:
To evaluate the safety of the preservative-free ophthalmic formulation PRO-087 (by Laboratorios Sophia, S.A. de C.V.) on the corneal and conjunctival epithelium, intraocular pressure, and structures of anterior and posterior segment in patients with tear film dysfunction syndrome from mild to moderate.
To determine the correlation between improvement of clinical status and perceived improvement of symptoms of each participant in each study group.
To compare the qualitative and quantitative histological status of the ocular surface before and after the pharmacological intervention in each study group to determine the evolution under the intervention of PRO-087.
To evaluate the quantitative rating of tear film production by the Schirmer Test throughout the study.
To qualitatively assess the tear film production by measuring the tear film break-up time stained with fluorescein and cobalt filter.
Blinding:
The double-blind study is a procedure in which the patient and the treating doctor ignore to which intervention group the study patient was assigned. To achieve the blinding of both the drug in research and both comparator drugs, these will be labeled in the same way (masking). Besides the figure of an unblinded pharmacist, who is responsible for the delivery of the medication to the patient, will be added. Blinding codes are protected by an outsider appointed by the study sponsor. The codes are also available in the research center (fully sealed), so that they can be consulted by the investigator in case a subject presents a serious adverse event, prior authorization from the study sponsor; the blinding also continues rigorous during the data analysis and interpretation.
patients with tear film dysfunction, classified as mild to moderate, will be included and randomized into 3 groups; the first being treated with PRO-087 ophthalmic solution, the second with Systane® Ultra ophthalmic solution, and the third with ophthalmic solution Systane® Ultra preservative free.
Pharmacological Intervention
The pharmacological intervention will be the instillation of the ophthalmic solution in the bottom of the conjunctival sac during the waking period, in any of the following study groups:
- Preservative free PRO-087 ophthalmic solution. Dropper bottle. Multidose 1 drop every 4 hours for 90 days.
- Systane® Ultra ophthalmic solution. Dropper bottle. Multidose. 1 drop every 4 hours for 90 days.
- Systane ® Ultra preservative free ophthalmic solution. Single-use vials. 1 drop every 4 hours for 90 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Controlled, double-blind, randomized, clinical trial comparing the safety and efficacy parameters between a group of subjects with a diagnose of mild to moderate tear film dysfunction syndrome under a regimen of ophthalmic solution lubricant drops PRO-087 versus subject under Systane® Ultra or Systane® Ultra preservative free, with the same diagnosis, with a follow-up of 90 days.
| Arm | Type | Receives |
|---|---|---|
| PRO-087 PF | Experimental | Drug: PRO-087Preservative free (PF) PRO-087 ophthalmic solution. Dropper bottle. Multidose 1 drop every 4 hours for 90 days. |
| Systane Ultra | Active comparator | Drug: Systane UltraSystane Ultra ophthalmic solution, Dropper bottle, Multidose. 1 drop every 4 hours for 90 days. |
| Systane Ultra PF | Active comparator | Drug: Systane Ultra Preservative FreeSystane Ultra, preservative free ophthalmic solution, single-use vials. 1 drop every 4 hours for 90 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- >18 to < 90 years old
- Both sexes
- Mild to moderate tear film dysfunction clinical diagnose
- Mild to moderate clinical stage of the disease
- Availability to go to each revision when indicated.
Key exclusion criteria (27 listed)
- General Criteria
- Subjects with topical and/or systemic medication or mechanical devices that interfere determinedly on the results of the study (such as topical immunomodulators, punctal plugs, corticosteroids, preservative artificial tears, contact lenses).
- Subjects (females) with active sexual life that do not use a contraceptive method.
- Female subjects who are pregnant or lactating
- Female subjects with a positive urine pregnancy test
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-087Also: Chondroitin sulfate, sodium hyaluronate0.1% sodium hyaluronate, free-preservative 0.18% chondroitin sulphate | Drug | PRO-087 PF |
| Systane UltraAlso: polyethylene glycol 400, propylene glycolIs a sterile solution containing polyethylene glycol 400, propylene glycol, hydroxypropyl-guar, sorbitol, aminomethylpropanol, boric acid, potassium chloride, sodium chloride and POLYQUAD® (poly-hydronium chloride) 0.001% as preservative. | Drug | Systane Ultra |
| Systane Ultra Preservative FreeAlso: Polyethylene Glycol 400 0.4%, Propylene Glycol 0.3%Polyethylene Glycol 400 0.4%Lubricant, Propylene Glycol 0.3% Lubricant, | Drug | Systane Ultra PF |
Primary outcome
Visual Acuity
Time frame: Change from Baseline visual acuity at 90 days
Best-corrected visual acuity
7 secondary outcomes
Corneal Epithelization Defects With Rose of Bengal
Time frame: Final Visit (day 90)
Tear Film Break-up Time (TBUT)
Time frame: Base line and Final Visit (day 90)
Schirmer Test
Time frame: Base line and Final Visit (day 90)
Adverse Events
Time frame: 90 days
Ocular Surface Disease Index (OSDI)
Time frame: Change from Baseline OSDI at 90 days
Goblet Cells Population
Time frame: Change from Baseline Goblet cells population at 90 days
Corneal Epithelization Defects With Fluorescein
Time frame: Final Visit (day 90)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. For security and laws implemented by the regulatory entity can not share personal data of research subjects.
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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.
Leopoldo Baiza, MD study director
Laboratorios Sophia S.A de C.V.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PRO-087, Systane Ultra and Systane Ultra Preservative Free in people with Dry Eye Syndrome, 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 9 inclusion and 27 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 31 Oct 2019. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 31 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 (time frame: Change from Baseline visual acuity at 90 days). 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 31 Oct 2019.