Dry Eye SyndromesPhase 2/3NCT00198536
Efficacy and Safety Study for Ecabet Ophthalmic Solution for Treating Dry Eye Syndrome
A Phase 2/3 study testing Ecabet 2.83% and Ecabet 3.70% in people with Dry Eye Syndromes, run by Bausch & Lomb Incorporated at 3 sites 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 2.83% and Ecabet 3.70%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 159 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2005to Dec 2005
- Phase
- Phase 2/3
- 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
Who may be able to join
- Agree to avoid systemic \& topical ophthalmic meds \& disallowed meds
- Have a best corrected visual acuity (BCVA) of 20/40 with pinhole or better in each eye
- Diagnosis of moderate dry eye syndrome
Who cannot join
- Uncontrolled ocular or systemic disease that could interfere with study
- Diagnosis of Sjogren's syndrome, lacrimal obstruction, reflex, lid-related or contact lens-related dry eye syndrome(DES); significant anterior blepharitis or meibomianitis
- Contraindications or hypersensitivity to use of study meds or components
- Wear contact lenses
- Secondary dry eye to surgery
- Eye surgery (including laser) within 6 months
Show all 9Show fewer
- Use of systemic or topical ophthalmic meds within 14 days
- Punctal plugs in one or both eyes in place for <45 days
- Permanent occlusion of the lacrimal puncta
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Andover Eye Associates
Andover, Massachusetts, 01840
Eyesight Ophthalmic Services, PA
Dover, New Hampshire, 03820
Central Maine Eye Care
Lewiston, Maine, 04240
About this study
Official title: Efficacy and Safety of Ecabet Ophthalmic Solution (2.83% and 3.70%) for 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 2.83%, Ecabet 3.70%, Vehicle
- 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.
Ecabet 2.83%Drug
Ecabet 3.70%Drug
VehicleDrug
| Study group | Role | What they receive |
|---|---|---|
| Ecabet 2.83% | Experimental | Ecabet ophthalmic solution One drop in study eye 4 times daily for 90 days. Receives: Drug: Ecabet 2.83% |
| Ecabet 3.70% | Experimental | Ecabet ophthalmic solution One drop in study eye 4 times daily for 90 days. Receives: Drug: Ecabet 3.70% |
| Vehicle | Placebo comparator | One drop of vehicle in study eye 4 times daily for 90 days. Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular discomfort
Group mean change in ocular discomfort score from pre-Cataract extraction (CAE) to post-CAE
Measured: Day 91
Tear Film Break-up Time (TFBUT)
Group mean change in time to tear break-up from pre-CAE to post-CAE.
Measured: Day 91
Blink Rate
Group mean change in blinks/min from pre-CAE to post-CAE.
Measured: Day 91
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startApr 2005
- Primary completionDec 2005
- Study completionDec 2005
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tim McNamara, PharmD, Study director, ISTA Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00198536
- Sponsor's protocol ID
- ISTA-ECBT-CS01
- Status last verified
- Mar 2013
- First submitted
- 13 Sep 2005
- Last updated
- 14 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Ecabet Ophthalmic Solution (2.83% and 3.70%) for Treatment of Dry Eye Syndrome
- ClinicalTrials.gov ID
- NCT00198536
- Acronym / sponsor ID
- ISTA-ECBT-CS01
- Conditions
- Dry Eye Syndromes
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 20 Sep 2005 (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 (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ecabet 2.83% | Experimental | Drug: Ecabet 2.83%Ecabet ophthalmic solution One drop in study eye 4 times daily for 90 days. |
| Ecabet 3.70% | Experimental | Drug: Ecabet 3.70%Ecabet ophthalmic solution One drop in study eye 4 times daily for 90 days. |
| Vehicle | Placebo comparator | Drug: VehicleOne drop of vehicle in study eye 4 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)
- Agree to avoid systemic \& topical ophthalmic meds \& disallowed meds
- Have a best corrected visual acuity (BCVA) of 20/40 with pinhole or better in each eye
- Diagnosis of moderate dry eye syndrome
Key exclusion criteria (9 listed)
- Uncontrolled ocular or systemic disease that could interfere with study
- Diagnosis of Sjogren's syndrome, lacrimal obstruction, reflex, lid-related or contact lens-related dry eye syndrome(DES); significant anterior blepharitis or meibomianitis
- Contraindications or hypersensitivity to use of study meds or components
- Wear contact lenses
- Secondary dry eye 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ecabet 2.83% | Drug | Ecabet 2.83% |
| Ecabet 3.70% | Drug | Ecabet 3.70% |
| Vehicle | Drug | Vehicle |
Primary outcome
Ocular discomfort
Time frame: Day 91
Group mean change in ocular discomfort score from pre-Cataract extraction (CAE) to post-CAE
Tear Film Break-up Time (TFBUT)
Time frame: Day 91
Group mean change in time to tear break-up from pre-CAE to post-CAE.
Blink Rate
Time frame: Day 91
Group mean change in blinks/min from pre-CAE to post-CAE.
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 14 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.
Tim McNamara, PharmD study director
ISTA Pharmaceuticals, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ecabet 2.83% and Ecabet 3.70% in people with Dry Eye Syndromes, run by Bausch & Lomb Incorporated at 3 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 14 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 3 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. 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 combined 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.
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.
What does the primary outcome measure?
Ocular discomfort (time frame: Day 91). The study lists 3 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 14 Mar 2013.