Dry Eye SyndromePhase 2PRO-148NCT01541891
Efficacy and Safety of PRO-148 Ophthalmic Solution Versus SYSTANE® in the Treatment of Patients With Dry Eye Syndrome
A Phase 2 study testing PRO-148 Ophthalmic Solution and Active Comparator: SYSTANE ® Ophthalmic Solution in people with Dry Eye Syndrome, run by Laboratorios Sophia S.A de C.V. at 1 site in Mexico.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of PRO-148 ophthalmic solution compared with SYSTANE ® ophthalmic solution for the treatment of signs and symptoms of mild-to-moderate dry eye syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndrome
- What is being tested?
- PRO-148 Ophthalmic Solution and Active Comparator: SYSTANE ® Ophthalmic Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteMexico
- Study dates
- Oct 2011to May 2012
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with diagnosis of mild-to-moderate drye eye syndrome.
- Male or female patients.
- Patients 18 years of age
Who cannot join
- Patients with one blind eye.
- Visual acuity of 20/40 in any eye
- Patients with history of active stage of any other concomitant ocular disease.
- Patients taking any medication, topically or by any other route, which could interfere with the study's results, in the 3 days prior to trial or until a time period in which residual effects could be present.
- Contraindications or sensitivity to any component of the study treatments.
- Ocular surgery within the past 3 months.
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- Contact lens users.
- Females of childbearing potential )may not participate in the study if any of the following conditions exist:
- They are pregnant,
- They are breastfeeding,
- They have a positive urine pregnancy test at screening,
- They intend to become pregnant during the study, or
- They do not agree to use adequate birth control methods for the duration of the study.
- Participation in any studies of investigational drugs within 90 days previous to the inclusion.
- Discontinuation criteria:
- Patients could be discontinued before the completion of the study because of adverse events, pregnancy, protocol violations, lack of efficacy, or administrative reasons.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"
Guadalajara, Jalisco, 44280
About this study
Official title: Fase II Comparative Study of the Efficacy and Safety of PRO-148 Ophthalmic Solution vs Systane in the Treatment of Mild-to-moderate Eye Syndrome.
The purpose of this study is to evaluate the efficacy and safety of PRO-148 ophthalmic solution compared with SYSTANE ® ophthalmic solution for the treatment of signs and symptoms of mild-to-moderate dry eye syndrome.
Read the detailed description
A phase 2, randomized, double masked clinical, parallel-group clinical trial to evaluate the efficacy and safety of PRO-148 ophthalmic solution compared with SYSTANE ® ophthalmic solution for the treatment of signs and symptoms of mild-to-moderate dry eye syndrome.
- Conditions
- Dry Eye Syndrome
- Being tested
- PRO-148 Ophthalmic Solution, Active Comparator: SYSTANE ® Ophthalmic Solution
- Keywords
- PRO-148, Dry eye syndrome
- 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-148 Ophthalmic SolutionDrug
Also called PRO-148
PRO-148 Ophthalmic Solution applied four times per day (c/6 hours) during 60 days.
Active Comparator: SYSTANE ® Ophthalmic SolutionDrug
Sterile solution containing polyethylene glycol 400, propylene glycol, hydroxypropyl-guar, boric acid, calcium chloride, magnesium chloride, potassium chloride, sodium chloride, zinc chloride and polyquad (polidronium chloride) 0,001%. four times per day (c/6 hours) during 60 days.
| Study group | Role | What they receive |
|---|---|---|
| PRO-148 Ophthalmic Solution | Experimental | Drug: PRO-148 Intervention name: PRO-148 applied in ocular surface of patients with mild to moderate dry eye syndrome q.i.d. for 60 days Receives: Drug: PRO-148 Ophthalmic Solution |
| Arm B. SYSTANE® Ophthalmic Solution | Active comparator | Drug: SYSTANE® Intervention name: SYSTANE® applied in ocular surface of patients with mild to moderate dry eye syndrome q.i.d. for 60 days Receives: Drug: Active Comparator: SYSTANE ® Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear Film Break-up Time (TBUT)
TBUT was evaluated at baseline and end of the study
Measured: During 60 days
Secondary outcomes (1)
Presence of Adverse Events
The presence of adverse events will be reported in both treatment arms. This variable will be reported by the number of events presented.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2012 (estimated)
- Study startOct 2011
- Primary completionMar 2012
- Study completionMay 2012
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 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, Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"Laura R Saucedo-Rodíguez, MD, Principal investigator, Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"Leopoldo M Baiza-Durán, MD, Study director, Clinical Research Department. Laboratorios Sophia SA de CV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01541891
- Sponsor's protocol ID
- COXAVSSY0311FII
- Other IDs
- PRO-148
- Acronym
- PRO-148
- Status last verified
- Feb 2018
- First submitted
- 20 Feb 2012
- Last updated
- 30 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fase II Comparative Study of the Efficacy and Safety of PRO-148 Ophthalmic Solution vs Systane in the Treatment of Mild-to-moderate Eye Syndrome.
- ClinicalTrials.gov ID
- NCT01541891
- Acronym / sponsor ID
- PRO-148 / COXAVSSY0311FII
- Conditions
- Dry Eye Syndrome
- Keywords
- PRO-148, Dry eye syndrome
- Phase
- Phase 2
- 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
- Oct 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 1 Mar 2012 (estimated)
- Results
- Posted 30 Oct 2018
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 the efficacy and safety of PRO-148 ophthalmic solution compared with SYSTANE ® ophthalmic solution for the treatment of signs and symptoms of mild-to-moderate dry eye syndrome.
Detailed description
A phase 2, randomized, double masked clinical, parallel-group clinical trial to evaluate the efficacy and safety of PRO-148 ophthalmic solution compared with SYSTANE ® ophthalmic solution for the treatment of signs and symptoms of mild-to-moderate dry eye syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRO-148 Ophthalmic Solution | Experimental | Drug: PRO-148 Ophthalmic SolutionDrug: PRO-148 Intervention name: PRO-148 applied in ocular surface of patients with mild to moderate dry eye syndrome q.i.d. for 60 days |
| Arm B. SYSTANE® Ophthalmic Solution | Active comparator | Drug: Active Comparator: SYSTANE ® Ophthalmic SolutionDrug: SYSTANE® Intervention name: SYSTANE® applied in ocular surface of patients with mild to moderate dry eye syndrome q.i.d. for 60 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with diagnosis of mild-to-moderate drye eye syndrome.
- Male or female patients.
- Patients 18 years of age
Key exclusion criteria (16 listed)
- Patients with one blind eye.
- Visual acuity of 20/40 in any eye
- Patients with history of active stage of any other concomitant ocular disease.
- Patients taking any medication, topically or by any other route, which could interfere with the study's results, in the 3 days prior to trial or until a time period in which residual effects could be present.
- 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-148 Ophthalmic SolutionAlso: PRO-148PRO-148 Ophthalmic Solution applied four times per day (c/6 hours) during 60 days. | Drug | PRO-148 Ophthalmic Solution |
| Active Comparator: SYSTANE ® Ophthalmic SolutionSterile solution containing polyethylene glycol 400, propylene glycol, hydroxypropyl-guar, boric acid, calcium chloride, magnesium chloride, potassium chloride, sodium chloride, zinc chloride and polyquad (polidronium chloride) 0,001%. four times per day (c/6 hours) during 60 days. | Drug | Arm B. SYSTANE® Ophthalmic Solution |
Primary outcome
Tear Film Break-up Time (TBUT)
Time frame: During 60 days
TBUT was evaluated at baseline and end of the study
1 secondary outcome
Presence of Adverse Events
Time frame: 60 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
- 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.
José F Alaniz-De La O, MD principal investigator
Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"
Laura R Saucedo-Rodíguez, MD principal investigator
Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"
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 2 study testing PRO-148 Ophthalmic Solution and Active Comparator: SYSTANE ® Ophthalmic Solution 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 3 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 30 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 30 Oct 2018). 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?
Tear Film Break-up Time (TBUT) (time frame: During 60 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 30 Oct 2018.