Dry EyeNCT00833235
A Natural History Study of Patients With Dry Eye
An observational study of Dry Eye, run by Allergan at 17 sites in United States.
Trial summary
This is a multi-center, prospective, controlled, observational study of the natural history of patients with dry eye disease. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- Artificial Tears
- How many people
- 284 participants
- Where
- 17 sitesUnited States
- Study dates
- 1 Feb 2009to 6 Mar 2017
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: At least 200 dry eye patients (with at least 40% of patients with elevated biomarkers for ocular surface inflammation) will be enrolled at approximately 15-20 sites. Approximately 40-50 patients will be enrolled in the control group.
Who may be able to join
- Males at least 55 years old or females, at least 40 years old with perimenopausal symptoms
- Baseline OSDI score of ≥ 13
- Patients with mild to moderate dry eye (dry eye disease patients only; not applicable for control group)
Who cannot join
- Use of any topical cyclosporine ophthalmic emulsion within 3 months of baseline
- History of herpes keratitis or varicella zoster keratitis
- Any history of allergic conjunctivitis
- Temporary or permanent occlusion or cauterization of the lacrimal puncta for either eye
- Any anterior segment surgery involving a limbal or corneal incision (cataract surgery), keratorefractive procedure (LASIK, LASEK, PRK) within 12 months of baseline, or expectation of such surgery within 2 years
- Patients with known systemic disease
- Any history of corneal transplant
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
The Wilmer Eye Institute Johns Hopkins Hospital
Baltimore, Maryland, 21287
Minnesota Eye Consultants, P.A.
Bloomington, Minnesota, 55431
Cleveland Eye Clinic
Brecksville, Ohio, 44141
Cape Coral Eye Center, PA
Cape Coral, Florida, 33904
Mulqueeny Eye Centers
Creve Coeur, Missouri, 63141
Ophthalmic Partners Bala
Cynwyd, Pennsylvania, 19004
Eye Center of Northern Colorado
Fort Collins, Colorado, 80525
Alkek Eye Center, Department of Ophthalmology
Houston, Texas, 77030
The Eye Institute of West Florida
Largo, Florida, 33770
The Eye Clinic of Texas/ dba Texas Clinical Eye Research Center
League City, Texas, 77573
Jones Eye Institute
Little Rock, Arkansas, 72205
See Clearly Vision Group
McLean, Virginia, 22102
North Valley Eye Medical Group, Inc.
Mission Hills, California, 91345
Vanderbilt Eye Institute
Nashville, Tennessee, 37232
Milauskas Eye Institute
Rancho Mirage, California, 92270
Mercy Eye Specilaists
Springfield, Missouri, 65804
Hazleton Eye Specialists
Township, Pennsylvania, 16066
About this study
This is a multi-center, prospective, controlled, observational study of the natural history of patients with dry eye disease.
- Conditions
- Dry Eye
- Being tested
- Artificial Tears
- 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.
Artificial TearsOther
Artificial tears (any brand) may be used to treat dry eye symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Patients with dry eye | No treatment is prescribed for the study. Patient dry eye progression will be followed for up to 60 months. Patients may use artificial tears to treat their dry eye symptoms. Receives: Other: Artificial Tears | |
| Patients with no history of dry eye | No treatment is prescribed for this control group. Patients will be followed for up to 60 months. If needed, patients may use artificial tears. Receives: Other: Artificial Tears |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients with Progression of Dry Eye Disease
Measured: Baseline, 60 Months
Secondary outcomes (5)
Change from Baseline in Ocular Surface Disease Index© (OSDI©) Score
Measured: Baseline, 60 Months
Percentage of Patients with an Increase in Blurred Vision
Measured: Baseline, 60 Months
Change from Baseline in Schirmer's Test
Measured: Baseline, 60 Months
Change from Baseline in Conjunctival Staining Score on a 6-Point Scale
Measured: Baseline, 60 Months
Change from Baseline in Corneal Staining Score on a 6-Point Scale
Measured: Baseline, 60 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2009 (estimated)
- Study start1 Feb 2009
- Primary completion6 Mar 2017
- Study completion6 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tes Ignacio, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00833235
- Sponsor's protocol ID
- MA-RES-08-001
- Status last verified
- Jul 2017
- First submitted
- 30 Jan 2009
- Last updated
- 25 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
McDonnell PJ, Pflugfelder SC, Stern ME, Hardten DR, Conway T, Villanueva L, Hollander DA. Study design and baseline findings from the progression of ocular findings (PROOF) natural history study of dry eye. BMC Ophthalmol. 2017 Dec 28;17(1):265. doi: 10.1186/s12886-017-0646-5.
PubMed 29284427
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Natural History Study of Patients With Dry Eye
- ClinicalTrials.gov ID
- NCT00833235
- Acronym / sponsor ID
- MA-RES-08-001
- Conditions
- Dry Eye
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2009 (actual)
- Primary completion
- 6 Mar 2017 (actual)
- Study completion
- 6 Mar 2017 (actual)
- First posted
- 2 Feb 2009 (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.
This is a multi-center, prospective, controlled, observational study of the natural history of patients with dry eye disease.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with dry eye | – | Other: Artificial TearsNo treatment is prescribed for the study. Patient dry eye progression will be followed for up to 60 months. Patients may use artificial tears to treat their dry eye symptoms. |
| Patients with no history of dry eye | – | Other: Artificial TearsNo treatment is prescribed for this control group. Patients will be followed for up to 60 months. If needed, patients may use artificial tears. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- At least 200 dry eye patients (with at least 40% of patients with elevated biomarkers for ocular surface inflammation) will be enrolled at approximately 15-20 sites. Approximately 40-50 patients will be enrolled in the control group.
Key inclusion criteria (3 listed)
- Males at least 55 years old or females, at least 40 years old with perimenopausal symptoms
- Baseline OSDI score of ≥ 13
- Patients with mild to moderate dry eye (dry eye disease patients only; not applicable for control group)
Key exclusion criteria (7 listed)
- Use of any topical cyclosporine ophthalmic emulsion within 3 months of baseline
- History of herpes keratitis or varicella zoster keratitis
- Any history of allergic conjunctivitis
- Temporary or permanent occlusion or cauterization of the lacrimal puncta for either eye
- Any anterior segment surgery involving a limbal or corneal incision (cataract surgery), keratorefractive procedure (LASIK, LASEK, PRK) within 12 months of baseline, or expectation of such surgery within 2 years
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 |
|---|---|---|
| Artificial TearsArtificial tears (any brand) may be used to treat dry eye symptoms. | Other | Patients with dry eye, Patients with no history of dry eye |
Primary outcome
Percentage of Patients with Progression of Dry Eye Disease
Time frame: Baseline, 60 Months
5 secondary outcomes
Change from Baseline in Ocular Surface Disease Index© (OSDI©) Score
Time frame: Baseline, 60 Months
Percentage of Patients with an Increase in Blurred Vision
Time frame: Baseline, 60 Months
Change from Baseline in Schirmer's Test
Time frame: Baseline, 60 Months
Change from Baseline in Conjunctival Staining Score on a 6-Point Scale
Time frame: Baseline, 60 Months
Change from Baseline in Corneal Staining Score on a 6-Point Scale
Time frame: Baseline, 60 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 25 Jul 2017.
- Derived from this study: PubMed 29284427McDonnell PJ, Pflugfelder SC, Stern ME, Hardten DR, Conway T, Villanueva L, Hollander DA. Study design and baseline findings from the progression of ocular findings (PROOF) natural history study of dry eye. BMC Ophthalmol. 2017 Dec 28;17(1):265. doi: 10.1186/s12886-017-0646-5.
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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.
Tes Ignacio study director
Allergan
17 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, run by Allergan at 17 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 7 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 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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?
Percentage of Patients with Progression of Dry Eye Disease (time frame: Baseline, 60 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00833235, which also lists 1 linked publication.
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 Jul 2017.