Dry Eye SyndromeNCT02522312
A Retrospective Analysis of Restasis® Benefits in Dry Eye Contact Lens Patients
An observational study of Dry Eye Syndrome, run by Hazleton Eye Specialists at 1 site in United States.
Trial summary
A retrospective analysis of Restasis® benefits in dry eye contact lens patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndrome
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Dec 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary Care Clinic
Who may be able to join
- Male or Female, > or = 18 years of age
- Subject was previously diagnosed (prior to Baseline Visit) with mild to severe dry eye disease (ITF level 1, 2 or 3) which required continuous medical therapy with Restasis® for a minimum duration of 6 months post-Baseline (Visit 1); or Subject was newly diagnosed (at Baseline Visit) with mild to severe dry eye disease (ITF level 1, 2 or 3) which required continuous medical therapy with Restasis® for a minimum duration of 6 months post-Baseline (Visit 1);
- Subject was prescribed Restasis® therapy at Baseline Visit (Visit 1) and commenced dosing immediately after Baseline Visit (Visit 1)
- Baseline Visit occured between 01 July 2012 and 01 January 2014;
- Subject had corneal staining and at least one dry eye sign (i.e., Schirmer's Test score <10 mm, decreased tear lake, TBUT <10 seconds, conjunctival staining, tear osmolarity >310 mOsmol/L
- Subject had charted tolerability and efficacy data reflecting at least one follow-up visit following Restasis® treatment initiation; and
- Subject wore contact lens(es) concurrently while receiving Restasis® treatment for a minimum duration of 6 months post-Baseline (Visit 1)
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Hazleton Eye Specialists
Hazleton, Pennsylvania, 18202
About this study
A retrospective analysis of Restasis® benefits in dry eye contact lens patients.
Read the detailed description
Charts of contact lens wearers with diagnosed dry eye who are being treated with Restasis will be evaluated to determine success in treatment by retrospectively looking at various outcome measures including but not limited to schirmer, staining and osmolarity levels
- Conditions
- Dry Eye Syndrome
- Being tested
- No Intervention
- Keywords
- Dry Eye
- 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 InterventionOther
No drug is administered in this study
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of Schirmer's Test score
Measured: 6 months
Increased contact lens wear time
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hazleton Eye Specialists
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Thomas P. Kislan, Hazleton Eye Specialists
- Investigators
- Thomas P Kislan, Dr., Principal investigator, Owner
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02522312
- Sponsor's protocol ID
- IIT-00864
- Status last verified
- Mar 2016
- First submitted
- 29 Jul 2015
- Last updated
- 3 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Analysis of Restasis® Benefits in Dry Eye Contact Lens Patients
- ClinicalTrials.gov ID
- NCT02522312
- Acronym / sponsor ID
- IIT-00864
- Conditions
- Dry Eye Syndrome
- Keywords
- Dry Eye
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Hazleton Eye SpecialistsUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 13 Aug 2015 (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.
A retrospective analysis of Restasis® benefits in dry eye contact lens patients.
Detailed description
Charts of contact lens wearers with diagnosed dry eye who are being treated with Restasis will be evaluated to determine success in treatment by retrospectively looking at various outcome measures including but not limited to schirmer, staining and osmolarity levels
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Care Clinic
Key inclusion criteria (7 listed)
- Male or Female, > or = 18 years of age
- Subject was previously diagnosed (prior to Baseline Visit) with mild to severe dry eye disease (ITF level 1, 2 or 3) which required continuous medical therapy with Restasis® for a minimum duration of 6 months post-Baseline (Visit 1); or Subject was newly diagnosed (at Baseline Visit) with mild to severe dry eye disease (ITF level 1, 2 or 3) which required continuous medical therapy with Restasis® for a minimum duration of 6 months post-Baseline (Visit 1);
- Subject was prescribed Restasis® therapy at Baseline Visit (Visit 1) and commenced dosing immediately after Baseline Visit (Visit 1)
- Baseline Visit occured between 01 July 2012 and 01 January 2014;
- Subject had corneal staining and at least one dry eye sign (i.e., Schirmer's Test score <10 mm, decreased tear lake, TBUT <10 seconds, conjunctival staining, tear osmolarity >310 mOsmol/L
Key exclusion criteria (1 listed)
- -
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 InterventionNo drug is administered in this study | Other | – |
Primary outcome
Improvement of Schirmer's Test score
Time frame: 6 months
Increased contact lens wear time
Time frame: 6 months
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 3 Mar 2016.
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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.
Thomas P Kislan, Dr. principal investigator
Owner
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 Syndrome, run by Hazleton Eye Specialists 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 7 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 3 Mar 2016. 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?
Improvement of Schirmer's Test score (time frame: 6 months). 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 3 Mar 2016.