Dry EyePhase 2NCT00893139
A Study of AL-38583 Ophthalmic Solution 0.05%, 0.010% Versus AL-38583 Vehicle for Dry Eye
A Phase 2 study testing AL-38583 ophthalmic solution 0.05% and AL-38583 ophthalmic solution 0.10% in people with Dry Eye, run by Alcon Research.
Trial summary
The purpose of this study is to determine whether AL-38583 ophthalmic solution is effective for treatment of signs and symptoms of dry eye. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- AL-38583 ophthalmic solution 0.05% and AL-38583 ophthalmic solution 0.10%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 765 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to Jan 2010
- 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
- Composite corneal staining score of greater than 5 in one or both eyes.
- Schirmer II score of greater than 4 mm.
- OSDI score of greater than 23.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Any medical condition (systemic or ophthalmic) that may, in the opinion of the investigator, preclude the safe administration of the test article or safe participation in this study.
- Other protocol-defined exclusion criteria may apply.
About this study
The purpose of this study is to determine whether AL-38583 ophthalmic solution is effective for treatment of signs and symptoms of dry eye.
- Conditions
- Dry Eye
- Being tested
- AL-38583 ophthalmic solution 0.05%, AL-38583 ophthalmic solution 0.10%, AL-38583 vehicle
- Keywords
- Dry Eye
- 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.
AL-38583 ophthalmic solution 0.05%Drug
AL-38583 ophthalmic solution 0.10%Drug
AL-38583 vehicleDrug
Inactive ingredients used as a placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| AL-38583 0.05% | Experimental | AL-38583 ophthalmic solution 0.05%, 1 drop per eye, 3 times a day, for 35 days Receives: Drug: AL-38583 ophthalmic solution 0.05% |
| AL-38583 0.10% | Experimental | AL-38583 ophthalmic solution 0.10%, 1 drop per eye, 3 times a day, for 35 days Receives: Drug: AL-38583 ophthalmic solution 0.10% |
| AL-38583 vehicle | Placebo comparator | Inactive ingredients used as a placebo comparator, 1 drop per eye, 3 times a day, for 35 days Receives: Drug: AL-38583 vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in sodium fluorescein corneal staining score
Measured: Baseline, up to Day 35
Secondary outcomes (1)
Mean change from baseline in phenol red thread length
Measured: Baseline, up to Day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2009 (estimated)
- Study startJun 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies 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
- 765 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ravaughn Williams, OD, MS, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00893139
- Sponsor's protocol ID
- C-08-077
- Status last verified
- Jul 2014
- First submitted
- 4 May 2009
- Last updated
- 15 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of AL-38583 Ophthalmic Solution 0.05%, 0.010% Versus AL-38583 Vehicle for Dry Eye
- ClinicalTrials.gov ID
- NCT00893139
- Acronym / sponsor ID
- C-08-077
- Conditions
- Dry Eye
- Keywords
- Dry Eye
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 765 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 5 May 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.
The purpose of this study is to determine whether AL-38583 ophthalmic solution is effective for treatment of signs and symptoms of dry eye.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AL-38583 0.05% | Experimental | Drug: AL-38583 ophthalmic solution 0.05%AL-38583 ophthalmic solution 0.05%, 1 drop per eye, 3 times a day, for 35 days |
| AL-38583 0.10% | Experimental | Drug: AL-38583 ophthalmic solution 0.10%AL-38583 ophthalmic solution 0.10%, 1 drop per eye, 3 times a day, for 35 days |
| AL-38583 vehicle | Placebo comparator | Drug: AL-38583 vehicleInactive ingredients used as a placebo comparator, 1 drop per eye, 3 times a day, for 35 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Composite corneal staining score of greater than 5 in one or both eyes.
- Schirmer II score of greater than 4 mm.
- OSDI score of greater than 23.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (2 listed)
- Any medical condition (systemic or ophthalmic) that may, in the opinion of the investigator, preclude the safe administration of the test article or safe participation in this study.
- Other protocol-defined exclusion criteria may apply.
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 |
|---|---|---|
| AL-38583 ophthalmic solution 0.05% | Drug | AL-38583 0.05% |
| AL-38583 ophthalmic solution 0.10% | Drug | AL-38583 0.10% |
| AL-38583 vehicleInactive ingredients used as a placebo comparator | Drug | AL-38583 vehicle |
Primary outcome
Mean change from baseline in sodium fluorescein corneal staining score
Time frame: Baseline, up to Day 35
1 secondary outcome
Mean change from baseline in phenol red thread length
Time frame: Baseline, up to Day 35
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 Jul 2014.
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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.
Ravaughn Williams, OD, MS study director
Alcon Research
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AL-38583 ophthalmic solution 0.05% and AL-38583 ophthalmic solution 0.10% in people with Dry Eye, run by Alcon Research.
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 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 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Mean change from baseline in sodium fluorescein corneal staining score (time frame: Baseline, up to Day 35). 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 Jul 2014.