Dry Eye SyndromesNCT01854905
An Observational Study of Dry Eye Prior to Laser-Assisted in Situ Keratomileusis (LASIK) Therapy
An observational study of Dry Eye Syndromes, run by Allergan at 1 site in Russia.
Trial summary
This is an observational, study of dry eye in patients at the consultation visit prior to LASIK surgery. There is no treatment administered or intervention during the study. 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?
- No Treatment
- How many people
- 400 participants
- Where
- 1 siteRussia
- Study dates
- May 2013to Sep 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 consulting with ophthalmologist for possible LASIK
Who may be able to join
- Attending an ophthalmology consultation for LASIK
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
This is an observational, study of dry eye in patients at the consultation visit prior to LASIK surgery. There is no treatment administered or intervention during the study.
- Conditions
- Dry Eye Syndromes
- Being tested
- No Treatment
- 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.
No TreatmentOther
Patients attending consultation for LASIK on Day 1. No intervention or treatment is administered during the study.
| Study group | Role | What they receive |
|---|---|---|
| Patients Attending Consultation for LASIK | Patients attending consultation for LASIK on Day 1. No intervention or treatment is administered during the study. Receives: Other: No Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients in Each Category of the Dry Eye Workshop Severity (DEWS) Scale
The severity of each patient's dry eye was classified by the physician according to the DEWS scale. Categories are: mild and/or episodic, occurs under environmental stress; moderate episodic or chronic, stress or no stress; and severe frequent or constant without stress
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2013 (estimated)
- Study startMay 2013
- Primary completionSep 2013
- Study completionSep 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 400 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
- NCT01854905
- Sponsor's protocol ID
- MAF-AGN-OPH-DE-015
- Status last verified
- Jan 2014
- First submitted
- 14 May 2013
- Last updated
- 14 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 14 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Dry Eye Prior to Laser-Assisted in Situ Keratomileusis (LASIK) Therapy
- ClinicalTrials.gov ID
- NCT01854905
- Acronym / sponsor ID
- MAF-AGN-OPH-DE-015
- Conditions
- Dry Eye Syndromes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 16 May 2013 (estimated)
- Results
- Posted 14 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 dry eye in patients at the consultation visit prior to LASIK surgery. There is no treatment administered or intervention during the study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Attending Consultation for LASIK | – | Other: No TreatmentPatients attending consultation for LASIK on Day 1. No intervention or treatment is administered during the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients consulting with ophthalmologist for possible LASIK
Key inclusion criteria (1 listed)
- Attending an ophthalmology consultation for LASIK
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 |
|---|---|---|
| No TreatmentPatients attending consultation for LASIK on Day 1. No intervention or treatment is administered during the study. | Other | Patients Attending Consultation for LASIK |
Primary outcome
Percentage of Patients in Each Category of the Dry Eye Workshop Severity (DEWS) Scale
Time frame: Day 1
The severity of each patient's dry eye was classified by the physician according to the DEWS scale. Categories are: mild and/or episodic, occurs under environmental stress; moderate episodic or chronic, stress or no stress; and severe frequent or constant without stress
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 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 Russia.
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 1 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 14 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 Russia. 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 14 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?
Percentage of Patients in Each Category of the Dry Eye Workshop Severity (DEWS) Scale (time frame: Day 1). 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 14 Mar 2014.