Dry EyePhase 4NCT03079271
An Open Label Comparing the Short Term Efficacy of Lacrisert
A Phase 4 study testing Lacrisert, 5 Mg Ophthalmic Insert in people with Dry Eye, run by Virginia Eye Consultants at 1 site in United States.
Trial summary
To evaluate the short term effects of LACRISERT®. upon fluorescein corneal staining, tear osmolarity and surface topography in human subjects with dry eye disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- Lacrisert, 5 Mg Ophthalmic Insert
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Dec 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- -Has Dry Eye disease indicated by a staining score of ≥ 4 and Speed score of >6
Who cannot join
- Concurrent involvement in any other clinical trial
- Anticipated contact lens wear during the study and 14hours prior to Day -History of corneal transplant
- Active ocular infection, uveitis or non-KCS inflammation
- History of recurrent herpes keratitis or active disease within the last six months
- Topical ophthalmic medications during the study
- Temporary collagen punctal plugs within one week prior to study.
Trial locations and contacts
1 site in 1 country.
Jireh A contact
United States1 site, 1 recruiting
- Recruiting
Virginia Eye Consultants
Norfolk, Virginia, 23502
jireh A, COA, 757-961-2947
John D Sheppard, M.D.
About this study
To evaluate the short term effects of LACRISERT®. upon fluorescein corneal staining, tear osmolarity and surface topography in human subjects with dry eye disease.
- Conditions
- Dry Eye
- Being tested
- Lacrisert, 5 Mg Ophthalmic Insert
- 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.
Lacrisert, 5 Mg Ophthalmic InsertDrug
| Study group | Role | What they receive |
|---|---|---|
| open label | Other | Not described Receives: Drug: Lacrisert, 5 Mg Ophthalmic Insert |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dry Eye disease measured by OSDI questionnaire
Measured: 10 days
Dry eye disease measured by Corneal Staining
Measured: 10 days
Dry eye disease measured by topographic results
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2017
- Study startNov 2016
- Primary completionJun 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Eye Consultants
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03079271
- Sponsor's protocol ID
- VEC-LAC001
- Status last verified
- Mar 2017
- First submitted
- 23 Nov 2016
- Last updated
- 14 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Comparing the Short Term Efficacy of Lacrisert
- ClinicalTrials.gov ID
- NCT03079271
- Acronym / sponsor ID
- VEC-LAC001
- Conditions
- Dry Eye
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Virginia Eye ConsultantsUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 14 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the short term effects of LACRISERT®. upon fluorescein corneal staining, tear osmolarity and surface topography in human subjects with dry eye disease.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| open label | Other | Drug: Lacrisert, 5 Mg Ophthalmic Insert |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Has Dry Eye disease indicated by a staining score of ≥ 4 and Speed score of >6
Key exclusion criteria (6 listed)
- Concurrent involvement in any other clinical trial
- Anticipated contact lens wear during the study and 14hours prior to Day -History of corneal transplant
- Active ocular infection, uveitis or non-KCS inflammation
- History of recurrent herpes keratitis or active disease within the last six months
- Topical ophthalmic medications during the study
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 |
|---|---|---|
| Lacrisert, 5 Mg Ophthalmic Insert | Drug | open label |
Primary outcome
Dry Eye disease measured by OSDI questionnaire
Time frame: 10 days
Dry eye disease measured by Corneal Staining
Time frame: 10 days
Dry eye disease measured by topographic results
Time frame: 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
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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.
Jireh A contact
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 Lacrisert, 5 Mg Ophthalmic Insert in people with Dry Eye, run by Virginia Eye Consultants at 1 site in United States.
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 6 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: status not confirmed, as of the sponsor's last update on 14 Mar 2017. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jireh A (757-961-2950), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dry Eye disease measured by OSDI questionnaire (time frame: 10 days). The study lists 3 primary outcomes in all. 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 2017.