Dry EyeNCT00706940
Tear Dynamics After Restasis Treatment in Dry Eye Patients
An observational study of Dry Eye, run by University of Miami at 1 site in United States.
Trial summary
Observe the changes of tear volume in dry eye patients after Restasis treatment of 3 months and during 6-month follow-up after discontinuation of study treatment. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Dry Eye
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to 31 Dec 2016
- Phase
- Observational
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: dry eye patients more than 18 yrs old
Who may be able to join
- The participant will be eligible for entry in the study if s/he:
- Is at least 18 years old and has full legal capacity to volunteer;
- Has read and signed the IRB Informed Consent Document;
- Is willing and able to follow participant instructions;
- Has clear corneas;
- Has 20/100 uncorrected visual acuity or better;
- Has dry eye according to the study definition of DES (study subjects);
- Has not use Restasis within 3 months.
Who cannot join
- The subjects will ineligible for entry into the study if s/he:
- Has any systemic disease affecting ocular health except for Sjögren's syndrome;
- Is using any systemic or topical medications that will affect ocular health except for artificial tears;
- Has an active ocular disease other than DES, or Sjögren's syndrome
- Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities;
- Has limbal or bulbar injection or corneal staining that was clinically significant, which are not due to DES;
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- Has worn rigid gas permeable lenses within 1 year and during the study;
- Has had surgery or an eye injury within 6 months;
- Was a soft contact lens wearer within 2 weeks and during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tear Dynamics After Restasis Treatment in Dry Eye Patients Phase II Clinical Trial and Phase IIb 6-month Follow-up After Discontinuation of Study Treatment
Observe the changes of tear volume in dry eye patients after Restasis treatment of 3 months and during 6-month follow-up after discontinuation of study treatment.
Read the detailed description
Using an imaging device name optical coherence tomography to image the tear volume in dry eye patients before and after Restasis treatment.
- Conditions
- Dry Eye
- Keywords
- dry eye, Optical coherence tomography
- Medical subject headings
- Dry Eye Syndromes
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in tear volume after the 3-month treatment and returned to baseline during 6-month follow-up after discontinuation of study treatment.
Measured: 3 months for treatment and follow-up of 6 months after discontinuation of study treatment.
Tear meniscus volume after treatment
Significant increase in tear meniscus volume was found in patients after 3 months of treatment.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2008 (estimated)
- Study startAug 2011
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
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.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Principal investigator, Jianhua (Jay) Wang, MD, PhD, University of Miami
- Investigators
- Jianhua Wang, MD, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00706940
- Sponsor's protocol ID
- 20080340
- Status last verified
- Apr 2017
- First submitted
- 26 Jun 2008
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tear Dynamics After Restasis Treatment in Dry Eye Patients Phase II Clinical Trial and Phase IIb 6-month Follow-up After Discontinuation of Study Treatment
- ClinicalTrials.gov ID
- NCT00706940
- Acronym / sponsor ID
- 20080340
- Conditions
- Dry Eye
- Keywords
- dry eye, Optical coherence tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Aug 2011
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 30 Jun 2008 (estimated)
- 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.
Observe the changes of tear volume in dry eye patients after Restasis treatment of 3 months and during 6-month follow-up after discontinuation of study treatment.
Detailed description
Using an imaging device name optical coherence tomography to image the tear volume in dry eye patients before and after Restasis treatment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- dry eye patients more than 18 yrs old
Key inclusion criteria (8 listed)
- Is at least 18 years old and has full legal capacity to volunteer;
- Has read and signed the IRB Informed Consent Document;
- Is willing and able to follow participant instructions;
- Has clear corneas;
- Has 20/100 uncorrected visual acuity or better;
Key exclusion criteria (9 listed)
- Has any systemic disease affecting ocular health except for Sjögren's syndrome;
- Is using any systemic or topical medications that will affect ocular health except for artificial tears;
- Has an active ocular disease other than DES, or Sjögren's syndrome
- Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities;
- Has limbal or bulbar injection or corneal staining that was clinically significant, which are not due to DES;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Increase in tear volume after the 3-month treatment and returned to baseline during 6-month follow-up after discontinuation of study treatment.
Time frame: 3 months for treatment and follow-up of 6 months after discontinuation of study treatment.
Tear meniscus volume after treatment
Time frame: 3 months
Significant increase in tear meniscus volume was found in patients after 3 months of treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 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.
Jianhua Wang, MD, PhD principal investigator
University of Miami
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, run by University of Miami 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 8 inclusion and 9 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 25 Apr 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Increase in tear volume after the 3-month treatment and returned to baseline during 6-month follow-up after discontinuation of study treatment. (time frame: 3 months for treatment and follow-up of 6 months after discontinuation of study treatment.). The study lists 2 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 25 Apr 2017.