Dry Eye SyndromesNCT01176045
TearLab Refractive Surgery Dry Eye Study
An observational study of Dry Eye Syndromes, run by TearLab Corporation at 8 sites in United States.
Trial summary
The primary objective of this study is to determine how pre \& post-operative tear osmolarity levels relate to rates of dry eye symptoms related to refractive surgery and if differences exist in patients who are pre-treated with ocular lubricants vs. those treated only post-operatively. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndromes
- How many people
- 128 participants
- Where
- 8 sitesUnited States
- Study dates
- Jun 2010to Dec 2011
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients scheduled to undergo refractive surgery with no previous diagnosis of dry eye disease.
Who may be able to join
- Male or female, twenty-one years of age or older.
- Confirmed diagnosis of refractive error receiving LASIK surgery.
- Patient motivation and willingness to cooperate with the investigator and ability to return for all visits during the study.
Who cannot join
- Compromised cognitive ability that may be expected to interfere with study compliance.
- Clinically significant eyelid deformity or eyelid movement disorder that is caused by conditions such as notch deformity, incomplete lid closure, entropion, ectropion, hordeola or chalazia.
- Previous ocular disease leaving sequelae or requiring current topical eye therapy other than for DED, including, but not limited to: active corneal or conjunctival infection of the eye and ocular surface scarring.
- Active ocular allergy
- Patients requiring punctual occlusion prior to surgery
- Patients requiring cyclosporine ophthalmic emulsion prior to surgery
Show all 9Show fewer
- Standard exclusion criteria for refractive surgery used by each surgeon.
- Known hypersensitivity to any of the agents used in testing
- Ophthalmologic drop use within 2 hours of any visit
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Connecticut TLC
Fairfield, Connecticut, 06824
Kremer Eye Center
King of Prussia, Pennsylvania, 16406
Oklahoma City TLC
Oklahoma City, Oklahoma, 73116
Reston TLC
Reston, Virginia, 20191
Salt Lake City TLC
Salt Lake City, Utah, 84121
San Antonio TLC
San Antonio, Texas, 78232
Tulsa TLC
Tulsa, Oklahoma, 74133
Westchester TLC
Westchester, Illinois, 60154
About this study
Official title: Measurement of Refractive Surgery Induced Dry Eye Using Tear Osmolarity Testing
The primary objective of this study is to determine how pre \& post-operative tear osmolarity levels relate to rates of dry eye symptoms related to refractive surgery and if differences exist in patients who are pre-treated with ocular lubricants vs. those treated only post-operatively.
Read the detailed description
Dry eye disease is a common and major source of disability, whether occurring as a primary disorder or as a component of other diseases and its onset may be triggered or modified by exposure to systemic drugs, contact lens wear, ocular surgery and adverse environmental and work conditions. The development of a reliable, highly sensitive and specific test for the clinical diagnosis of dry eye is a major unmet clinical need, particularly to differentiate it from common conditions such as ocular allergy which exhibit similar presenting symptoms. Tear hyper-osmolarity is central to the dry eye disease process and the measurement of tear osmolarity could serve not only as a highly accurate diagnostic test but also as a measure of disease severity and a means to monitor treatment efficacy.
Recently, there have been reports in the literature regarding dry eye disease; both early and chronic following refractive surgery, with many cases potentially being previously inadvertently undiagnosed dry eye disease.
- Conditions
- Dry Eye Syndromes
- Keywords
- Dry Eye Disease, Osmolarity, Refractive Surgery, Lasik, TearLab
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Pre-surgical treatment | Patients who are pre \& post-surgical treated with ocular lubricants. | |
| Non-presurgical treatment | Patients who are only post-surgical treated with ocular lubricants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relation of pre & post-operative tear osmolarity levels to dry eye and dry eye symptoms in refractive surgery
Measured: 6 months post surgery
Secondary outcomes (2)
To determine if differences exist in patients who are pre-treated with ocular lubricants vs. those treated only post-operatively
Measured: 6 months post-surgical
To determine if tear osmolarity levels relate to visual acuity outcomes related to refractive surgery
Measured: 6 months post-surgical
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- TearLab Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TLC Laser Eye Center, Abbott Medical Optics
- Responsible party
- Sponsor
- Investigators
- James Owen, OD, Study director, TLC The Laser Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01176045
- Sponsor's protocol ID
- TP00087
- Status last verified
- Feb 2016
- First submitted
- 3 Aug 2010
- Last updated
- 4 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Study data has been shared in Vienna 2011. Patients with pre-operative hyperosmolarity (≥ 308 mOsms/L) demonstrated worse long-term uncorrected visual acuity. An abnormal tear film may cause inaccurate wavefront aberrometry. For patients with preoperative osmolarity ≥ 308 mOsms/L, it may be important to continue therapy for at least 3 months. Similarly, surgeons should measure tear osmolarity preoperatively as staining was too insensitive to identify at-risk patients. Patients treated pre-operatively with AMO Blink® Tears achieved normal osmolarity faster than those untreated before surgery.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Refractive Surgery Induced Dry Eye Using Tear Osmolarity Testing
- ClinicalTrials.gov ID
- NCT01176045
- Acronym / sponsor ID
- TP00087
- Conditions
- Dry Eye Syndromes
- Keywords
- Dry Eye Disease, Osmolarity, Refractive Surgery, Lasik, TearLab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- TearLab CorporationIndustry (pharma, biotech, devices)
- Collaborators
- TLC Laser Eye Center, Abbott Medical Optics
- Study start
- Jun 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 5 Aug 2010 (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.
The primary objective of this study is to determine how pre \& post-operative tear osmolarity levels relate to rates of dry eye symptoms related to refractive surgery and if differences exist in patients who are pre-treated with ocular lubricants vs. those treated only post-operatively.
Detailed description
Dry eye disease is a common and major source of disability, whether occurring as a primary disorder or as a component of other diseases and its onset may be triggered or modified by exposure to systemic drugs, contact lens wear, ocular surgery and adverse environmental and work conditions. The development of a reliable, highly sensitive and specific test for the clinical diagnosis of dry eye is a major unmet clinical need, particularly to differentiate it from common conditions such as ocular allergy which exhibit similar presenting symptoms. Tear hyper-osmolarity is central to the dry eye disease process and the measurement of tear osmolarity could serve not only as a highly accurate diagnostic test but also as a measure of disease severity and a means to monitor treatment efficacy.
Recently, there have been reports in the literature regarding dry eye disease; both early and chronic following refractive surgery, with many cases potentially being previously inadvertently undiagnosed dry eye disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-surgical treatment | – | –Patients who are pre \& post-surgical treated with ocular lubricants. |
| Non-presurgical treatment | – | –Patients who are only post-surgical treated with ocular lubricants |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled to undergo refractive surgery with no previous diagnosis of dry eye disease.
Key inclusion criteria (3 listed)
- Male or female, twenty-one years of age or older.
- Confirmed diagnosis of refractive error receiving LASIK surgery.
- Patient motivation and willingness to cooperate with the investigator and ability to return for all visits during the study.
Key exclusion criteria (9 listed)
- Compromised cognitive ability that may be expected to interfere with study compliance.
- Clinically significant eyelid deformity or eyelid movement disorder that is caused by conditions such as notch deformity, incomplete lid closure, entropion, ectropion, hordeola or chalazia.
- Previous ocular disease leaving sequelae or requiring current topical eye therapy other than for DED, including, but not limited to: active corneal or conjunctival infection of the eye and ocular surface scarring.
- Active ocular allergy
- Patients requiring punctual occlusion prior to surgery
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
Relation of pre & post-operative tear osmolarity levels to dry eye and dry eye symptoms in refractive surgery
Time frame: 6 months post surgery
2 secondary outcomes
To determine if differences exist in patients who are pre-treated with ocular lubricants vs. those treated only post-operatively
Time frame: 6 months post-surgical
To determine if tear osmolarity levels relate to visual acuity outcomes related to refractive surgery
Time frame: 6 months post-surgical
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 4 Feb 2016.
- Individual participant dataSharing planned: Yes. Study data has been shared in Vienna 2011. Patients with pre-operative hyperosmolarity (≥ 308 mOsms/L) demonstrated worse long-term uncorrected visual acuity. An abnormal tear film may cause inaccurate wavefront aberrometry. For patients with preoperative osmolarity ≥ 308 mOsms/L, it may be important to continue therapy for at least 3 months. Similarly, surgeons should measure tear osmolarity preoperatively as staining was too insensitive to identify at-risk patients. Patients treated pre-operatively with AMO Blink® Tears achieved normal osmolarity faster than those untreated before surgery.
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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.
James Owen, OD study director
TLC The Laser Eye Center
8 sites 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 TearLab Corporation at 8 sites 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 3 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 4 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
Relation of pre & post-operative tear osmolarity levels to dry eye and dry eye symptoms in refractive surgery (time frame: 6 months post surgery). 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 4 Feb 2016.