Dry Eye SyndromesNCT01711424
An Observational Study of OPTIVE PLUS® for the Treatment of Dry Eye Disease
An observational study of Dry Eye Syndromes, run by Allergan at 1 site in Germany.
Trial summary
This is an observational study of OPTIVE PLUS® in patients with dry eye disease in a routine clinical setting. Treatment decisions are made by the physician and reflect the physician's current standard of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- OPTIVE PLUS®
- How many people
- 1,209 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2012to Mar 2013
- Phase
- Observational
- 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
Study population: Patients with dry eye
Who may be able to join
- Diagnosis of dry eye
- Physician decision to treat with OPTIVE PLUS® in accordance with the physician's standard practice
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
This is an observational study of OPTIVE PLUS® in patients with dry eye disease in a routine clinical setting. Treatment decisions are made by the physician and reflect the physician's current standard of care.
- Conditions
- Dry Eye Syndromes
- Being tested
- OPTIVE PLUS®
- 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.
OPTIVE PLUS®Drug
Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.
| Study group | Role | What they receive |
|---|---|---|
| OPTIVE PLUS® | Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice. Receives: Drug: OPTIVE PLUS® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Very Satisfied or Satisfied With OPTIVE PLUS®
Patients rated their satisfaction with OPTIVE PLUS® as treatment for dry eye signs and symptoms using a 4-point scale (Very satisfied, Satisfied, Dissatisfied or Very dissatisfied).
Measured: Week 4
Secondary outcomes (3)
Number of Participants Where Physician Was Very Satisfied or Satisfied With OPTIVE PLUS®
The physician rated their satisfaction with OPTIVE PLUS® for the treatment of their patient's dry eye signs and symptoms using a 4-point scale (Very satisfied, Satisfied, Dissatisfied or Very dissatisfied).
Measured: Week 4
Tear Break Up Time (TBUT)
TBUT is the time in seconds required for dry spots to appear on the corneal surface after blinking. The longer it takes, the more stable the tear film.
Measured: Baseline, Week 4
Schirmer Score
The Schirmer Test measures the rate of the secretion of tears produced by the eye over 5 minutes (min). The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye.
Measured: Baseline, Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionMar 2013
- Study completionMar 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 Dry Eye SyndromesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01711424
- Sponsor's protocol ID
- MAF/AGN/OPH/DE/012
- Status last verified
- Jan 2014
- First submitted
- 18 Oct 2012
- Last updated
- 17 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of OPTIVE PLUS® for the Treatment of Dry Eye Disease
- ClinicalTrials.gov ID
- NCT01711424
- Acronym / sponsor ID
- MAF/AGN/OPH/DE/012
- Conditions
- Dry Eye Syndromes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,209 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 22 Oct 2012 (estimated)
- Results
- Posted 17 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational study of OPTIVE PLUS® in patients with dry eye disease in a routine clinical setting. Treatment decisions are made by the physician and reflect the physician's current standard of care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OPTIVE PLUS® | – | Drug: OPTIVE PLUS®Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with dry eye
Key inclusion criteria (2 listed)
- Diagnosis of dry eye
- Physician decision to treat with OPTIVE PLUS® in accordance with the physician's standard practice
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| OPTIVE PLUS®Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice. | Drug | OPTIVE PLUS® |
Primary outcome
Number of Participants Very Satisfied or Satisfied With OPTIVE PLUS®
Time frame: Week 4
Patients rated their satisfaction with OPTIVE PLUS® as treatment for dry eye signs and symptoms using a 4-point scale (Very satisfied, Satisfied, Dissatisfied or Very dissatisfied).
3 secondary outcomes
Number of Participants Where Physician Was Very Satisfied or Satisfied With OPTIVE PLUS®
Time frame: Week 4
Tear Break Up Time (TBUT)
Time frame: Baseline, Week 4
Schirmer Score
Time frame: Baseline, Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2014.
- 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.
Medical Director study director
Allergan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye Syndromes, run by Allergan at 1 site in Germany.
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 1 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 Mar 2014. 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 Germany. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Mar 2014). 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?
Number of Participants Very Satisfied or Satisfied With OPTIVE PLUS® (time frame: Week 4). 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 Mar 2014.