Keratoconjunctivitis SiccaPhase 3NCT00025818
Six Month Clinical Research Study for Patients With Moderate or Severe Dry Eye Syndrome
A Phase 3 study testing Ophthalmic Emulsion in people with Keratoconjunctivitis Sicca and Sjogren's Syndrome, run by Allergan at 17 sites in United States.
Trial summary
A six-month clinical research trial to evaluate the effectiveness of an investigational medication for the treatment of dry eye syndrome in patients that have been diagnosed with moderate to severe dry eye syndrome, an autoimmune disorder AND/OR females 65 years of age or older. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratoconjunctivitis Sicca, Sjogren's Syndrome, Lupus Erythematosus, Systemic
- What is being tested?
- Ophthalmic Emulsion
- How many people
- 290 participants
- Where
- 17 sitesUnited States
- Study dates
- May 2001to Mar 2003
- Phase
- Phase 3
- 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
- Eighteen years or older
- Diagnosis of moderate to severe dry eyes for at least 6 months and meet one or all of the following criteria:
- Diagnosis of autoimmune disorder
- Female 65 years of age or older
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Cornea Consultants of Albany
Albany, New York, 12159
Emory University
Atlanta, Georgia, 30322
Dr. Freedman's Office
Brooklyn, New York, 11201
UIC Eye Center
Chicago, Illinois, 60612
The Cole Eye Institute
Cleveland, Ohio, 44195
Corona Research
El Paso, Texas, 79903
Baylor College of Medicine
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46202
Eyecare of La Jolla
La Jolla, California, 92037
D'Ambrosio Eye Care
Leominster, Massachusetts, 01453
UCLA
Los Angeles, California, 90095
Hunkleler Eye Center
Overland Park, Kansas, 66211
Northwest Cornea
Portland, Oregon, 97223
Great Lakes Eye Institute
Saginaw, Michigan, 48604
Dr. Wittpen's Office
Stony Brook, New York, 11790
Brandon Eye Clinic
Tampa, Florida, 33629
Opticare
Waterbury, Connecticut, 06708
About this study
A six-month clinical research trial to evaluate the effectiveness of an investigational medication for the treatment of dry eye syndrome in patients that have been diagnosed with moderate to severe dry eye syndrome, an autoimmune disorder AND/OR females 65 years of age or older.
- Conditions
- Keratoconjunctivitis Sicca, Sjogren's Syndrome, Lupus Erythematosus, Systemic, Arthritis, Rheumatoid, Scleroderma, Systemic
- Being tested
- Ophthalmic Emulsion
- Keywords
- dry eyes, rheumatoid arthritis, Lupus, Sjogren's syndrome, myositis, scleroderma, autoimmune disorder
- Medical subject headings
- Keratoconjunctivitis Sicca, Sjogren's Syndrome, Lupus Erythematosus, Systemic, Arthritis, Rheumatoid, Scleroderma, Systemic, Dry Eye Syndromes, Myositis, Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ophthalmic EmulsionDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2001 (estimated)
- Study startMay 2001
- Primary completionMar 2003
- Study completionMar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keratoconjunctivitis SiccaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00025818
- Sponsor's protocol ID
- 192371-011-01
- Status last verified
- May 2011
- First submitted
- 26 Oct 2001
- Last updated
- 30 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Six Month Clinical Research Study for Patients With Moderate or Severe Dry Eye Syndrome
- ClinicalTrials.gov ID
- NCT00025818
- Acronym / sponsor ID
- 192371-011-01
- Conditions
- Keratoconjunctivitis Sicca, Sjogren's Syndrome, Lupus Erythematosus, Systemic, Arthritis, Rheumatoid, Scleroderma, Systemic
- Keywords
- dry eyes, rheumatoid arthritis, Lupus, Sjogren's syndrome, myositis, scleroderma, autoimmune disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- May 2001
- Primary completion
- Mar 2003 (actual)
- Study completion
- Mar 2003 (actual)
- First posted
- 29 Oct 2001 (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 six-month clinical research trial to evaluate the effectiveness of an investigational medication for the treatment of dry eye syndrome in patients that have been diagnosed with moderate to severe dry eye syndrome, an autoimmune disorder AND/OR females 65 years of age or older.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Ophthalmic Emulsion | Drug | – |
Primary outcome
Not reported in the source record.
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 30 May 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ophthalmic Emulsion in people with Keratoconjunctivitis Sicca and Sjogren's Syndrome, 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?
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 30 May 2011. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
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 30 May 2011.