Dry Eye SyndromesPhase 2NCT00370747
Efficacy and Safety Study for Ecabet Ophthalmic Solution for Treating Dry Eye Syndrome
A Phase 2 study testing Ecabet in people with Dry Eye Syndromes, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
The purpose of this study is to determine whether ecabet ophthalmic solution is an effective treatment for dry eye syndrome Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- Ecabet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Jun 2007
- Phase
- Phase 2
- 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
Who may be able to join
- Male/female at least 18 years of age
- Agree to avoid disallowed medications
- Have a diagnosis of dry eye
Who cannot join
- Have chronic systemic inflammation
- Have active seasonal ocular allergies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Ecabet Ophthalmic Solution for the Treatment of Dry Eye Syndrome
The purpose of this study is to determine whether ecabet ophthalmic solution is an effective treatment for dry eye syndrome
- Conditions
- Dry Eye Syndromes
- Being tested
- Ecabet, Placebo
- 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.
EcabetDrug
ophthalmic solution 2.83%
EcabetDrug
ophthalmic solution 3.70%
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Ecabet | Experimental | Ophthalmic solution in the Study eye four times daily for 90 days. Receives: Drug: Ecabet |
| Placebo | Placebo comparator | Ophthalmic solution in the Study eye four times daily for 90 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular signs and Symptoms
ocular signs, including corneal and conjunctival staining, tear film breakup time and blink rate, and ocular symptoms, including burning or stinging, itchiness or scratchiness, grittiness or sandiness, foreign body sensation, haziness or blurriness, photophobia, photopsia, and eye discomfort
Measured: 90 days
Secondary outcomes (1)
Ocular Surface Disease Index (OSDI)
Questionaire
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionJun 2007
- Study completionJun 2007
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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 162 participants
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ralph Bianca, PhD, Study director, ISTA Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00370747
- Sponsor's protocol ID
- ISTA-ECBT-CS02
- Status last verified
- Mar 2013
- First submitted
- 30 Aug 2006
- Last updated
- 15 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Ecabet Ophthalmic Solution for the Treatment of Dry Eye Syndrome
- ClinicalTrials.gov ID
- NCT00370747
- Acronym / sponsor ID
- ISTA-ECBT-CS02
- Conditions
- Dry Eye Syndromes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 1 Sep 2006 (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 purpose of this study is to determine whether ecabet ophthalmic solution is an effective treatment for dry eye syndrome
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ecabet | Experimental | Drug: EcabetOphthalmic solution in the Study eye four times daily for 90 days. |
| Placebo | Placebo comparator | Drug: PlaceboOphthalmic solution in the Study eye four times daily for 90 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male/female at least 18 years of age
- Agree to avoid disallowed medications
- Have a diagnosis of dry eye
Key exclusion criteria (2 listed)
- Have chronic systemic inflammation
- Have active seasonal ocular allergies
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 |
|---|---|---|
| Ecabetophthalmic solution 2.83% | Drug | Ecabet |
| Ecabetophthalmic solution 3.70% | Drug | Ecabet |
| Placebo | Drug | Placebo |
Primary outcome
Ocular signs and Symptoms
Time frame: 90 days
ocular signs, including corneal and conjunctival staining, tear film breakup time and blink rate, and ocular symptoms, including burning or stinging, itchiness or scratchiness, grittiness or sandiness, foreign body sensation, haziness or blurriness, photophobia, photopsia, and eye discomfort
1 secondary outcome
Ocular Surface Disease Index (OSDI)
Time frame: 90 days
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 15 Mar 2013.
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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.
Ralph Bianca, PhD study director
ISTA Pharmaceuticals, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ecabet in people with Dry Eye Syndromes, run by Bausch & Lomb Incorporated 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 3 inclusion and 2 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 15 Mar 2013. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
What does the primary outcome measure?
Ocular signs and Symptoms (time frame: 90 days). 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 15 Mar 2013.