Eyes Dry ChronicPhase 2NCT01338610
ESBA105 in Patients With Severe Dry Eye
A Phase 2 study testing ESBA105 ophthalmic solution in people with Eyes Dry Chronic, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of this study was to evaluate the efficacy of ESBA105 over vehicle in reducing the ocular symptoms of dry eye disease, as measured by a mean global Visual Analog Scale (VAS) discomfort score. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eyes Dry Chronic
- What is being tested?
- ESBA105 ophthalmic solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 334 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Feb 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Ongoing physician diagnosis of dry eye for at least 6 months.
- Use of artificial tears, gels, lubricants, or re-wetting drops on a regular basis.
- Experience persistent ocular discomfort.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Contact lens wearers.
- Severe Sjogren's Syndrome.
- History of corneal surgery including refractive surgeries.
- Intraocular surgery within 6 months of Visit 1.
- Intraocular or periocular injection within 6 months of Visit 1.
- Lid function abnormalities.
Show all 10Show fewer
- Use of steroids, tetracycline, doxycycline, etc., within 30 days of Visit 1.
- Any acute infectious or non-infectious ocular condition of the anterior or posterior segments in either eye within 30 days of Visit 1.
- Diseases/conditions of ocular surface associated with clinically significant scarring/destruction of conjunctiva/cornea.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, 76134
About this study
Official title: Evaluation of ESBA105 in the Persistent Relief of Ocular Discomfort in Patients With Severe Dry Eye
The purpose of this study was to evaluate the efficacy of ESBA105 over vehicle in reducing the ocular symptoms of dry eye disease, as measured by a mean global Visual Analog Scale (VAS) discomfort score.
Read the detailed description
Following Run-In, patients qualifying for treatment were randomized 2:1 to receive ESBA105 (experimental group) or Vehicle (control group) for 4 weeks. Patients not qualifying for treatment (based on global VAS discomfort score), were discontinued from the study.
- Conditions
- Eyes Dry Chronic
- Being tested
- ESBA105 ophthalmic solution, ESBA105 vehicle
- Keywords
- Ocular discomfort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESBA105 ophthalmic solutionBiological
ESBA105 vehicleOther
Inactive ingredients used as Run-In and placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| ESBA105 | Experimental | ESBA105 ophthalmic solution, 1 drop in each eye 3 times per day for 4 weeks Receives: Biological: ESBA105 ophthalmic solution |
| Vehicle | Placebo comparator | ESBA105 vehicle, 1 drop in each eye 3 times per day for 4 weeks Receives: Other: ESBA105 vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) Global Ocular Discomfort Score, Area Under the Curve, Day 0 to Day 28
An electronic Visual Analog Scale (eVAS) was used by the subject to assess ocular discomfort, both frequency and severity, at Day 0 (pre-treatment) and daily thereafter for 28 days. Assessments were entered into a LogPad® (handheld electronic device). The VAS frequency score ranged from 0 (rarely) to 100 (all the time), and the VAS severity score ranged from 0 (very mildly uncomfortable) to 100 (very severely uncomfortable). The Global Ocular Discomfort Score is a composite of the frequency and severity VAS scores (0-100).
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2011 (estimated)
- Study startJun 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Eyes Dry ChronicStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- 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
- Who is masked
- Participant, Investigator
- Enrolment
- 334 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01338610
- Sponsor's protocol ID
- C-10-079
- Status last verified
- Apr 2013
- First submitted
- 18 Apr 2011
- Last updated
- 19 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of ESBA105 in the Persistent Relief of Ocular Discomfort in Patients With Severe Dry Eye
- ClinicalTrials.gov ID
- NCT01338610
- Acronym / sponsor ID
- C-10-079
- Conditions
- Eyes Dry Chronic
- Keywords
- Ocular discomfort
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 334 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 19 Apr 2011 (estimated)
- Results
- Posted 19 Apr 2013
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 was to evaluate the efficacy of ESBA105 over vehicle in reducing the ocular symptoms of dry eye disease, as measured by a mean global Visual Analog Scale (VAS) discomfort score.
Detailed description
Following Run-In, patients qualifying for treatment were randomized 2:1 to receive ESBA105 (experimental group) or Vehicle (control group) for 4 weeks. Patients not qualifying for treatment (based on global VAS discomfort score), were discontinued from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESBA105 | Experimental | Biological: ESBA105 ophthalmic solutionESBA105 ophthalmic solution, 1 drop in each eye 3 times per day for 4 weeks |
| Vehicle | Placebo comparator | Other: ESBA105 vehicleESBA105 vehicle, 1 drop in each eye 3 times per day for 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ongoing physician diagnosis of dry eye for at least 6 months.
- Use of artificial tears, gels, lubricants, or re-wetting drops on a regular basis.
- Experience persistent ocular discomfort.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (10 listed)
- Contact lens wearers.
- Severe Sjogren's Syndrome.
- History of corneal surgery including refractive surgeries.
- Intraocular surgery within 6 months of Visit 1.
- Intraocular or periocular injection within 6 months of Visit 1.
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 |
|---|---|---|
| ESBA105 ophthalmic solution | Biological | ESBA105 |
| ESBA105 vehicleInactive ingredients used as Run-In and placebo comparator | Other | Vehicle |
Primary outcome
Visual Analog Scale (VAS) Global Ocular Discomfort Score, Area Under the Curve, Day 0 to Day 28
Time frame: Up to 28 days
An electronic Visual Analog Scale (eVAS) was used by the subject to assess ocular discomfort, both frequency and severity, at Day 0 (pre-treatment) and daily thereafter for 28 days. Assessments were entered into a LogPad® (handheld electronic device). The VAS frequency score ranged from 0 (rarely) to 100 (all the time), and the VAS severity score ranged from 0 (very mildly uncomfortable) to 100 (very severely uncomfortable). The Global Ocular Discomfort Score is a composite of the frequency and severity VAS scores (0-100).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
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 ESBA105 ophthalmic solution in people with Eyes Dry Chronic, run by Alcon Research 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 4 inclusion and 10 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 19 Apr 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?
Yes. Results are posted in the registry (first posted 19 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Visual Analog Scale (VAS) Global Ocular Discomfort Score, Area Under the Curve, Day 0 to Day 28 (time frame: Up to 28 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 19 Apr 2013.