Adenoviral ConjunctivitisPhase 2NCT00901693
An Evaluation of the Efficacy and Safety of AL-46383A Ophthalmic Solution for the Treatment of Adenoviral Conjunctivitis
A Phase 2 study testing AL-46383A Ophthalmic Solution in people with Adenoviral Conjunctivitis, run by Alcon Research.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of AL-46383A Ophthalmic Solution for the treatment of adenoviral conjunctivitis. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Adenoviral Conjunctivitis
- What is being tested?
- AL-46383A Ophthalmic Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 452 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to Jul 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- At least one eye must have EITHER a positive adenovirus test (using the Adeno Detector™ for Adenoviral Conjunctivitis, Rapid Pathogen Screening, Inc.) OR a positive clinical diagnosis assessed by the Adenoviral Clinical Diagnostic Checklist.
- Onset and development of ocular symptoms and/or signs of conjunctivitis ≤ 7 days prior to enrollment (Day 1) in either eye.
- Able to understand and sign an informed consent form that has been approved by an Institutional Review Board/ Independent Ethics Committee (IRB/IEC).
- Must agree to comply with the visit schedule and other requirements of the study.
- Females who are not pregnant and are not lactating. All females of childbearing potential (those who are not pre-menarcheal, not postmenopausal or surgically sterile) may participate only if they have a negative urine pregnancy test prior to randomization, and if they agree to use adequate birth control methods to prevent pregnancy throughout the study.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Sub-epithelial infiltrates at the Day 1 visit in either eye.
- Corneal opacity or any corneal abnormality at the Day 1 visit in either eye.
- Contact lens wear during the course of the study. Participants requiring correction must have spectacles with appropriate correction.
- Only one sighted eye or vision in either eye not correctable to 0.6 or better logMAR (using ETDRS chart) at the Day 1 visit.
- Abnormal findings in the posterior pole of the retina or any media opacity found in a dilated fundus examination at the Day 1 (Screening/ Baseline) visit.
- Suspected fungal, herpes, Chlamydia or Acanthamoeba infection, based on clinical observation.
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- History of active uveitis or iritis in either eye.
- History of corneal transplant in either eye.
- Presence of nasolacrimal duct obstruction at Day 1.
- Use of specified prohibited medications.
- Other protocol-defined exclusion criteria may apply.
About this study
The purpose of this study is to evaluate the safety and efficacy of AL-46383A Ophthalmic Solution for the treatment of adenoviral conjunctivitis.
- Conditions
- Adenoviral Conjunctivitis
- Being tested
- AL-46383A Ophthalmic Solution, AL-46383A Ophthalmic Solution Vehicle
- Keywords
- pink eye, eye infection, conjunctivitis
- Medical subject headings
- Conjunctivitis, Eye Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AL-46383A Ophthalmic SolutionDrug
AL-46383A Ophthalmic Solution VehicleDrug
| Study group | Role | What they receive |
|---|---|---|
| AL-46383A | Experimental | AL-46383A Ophthalmic Solution, 1 drop in each eye, 8 times a day for 10 days Receives: Drug: AL-46383A Ophthalmic Solution |
| Vehicle | Placebo comparator | AL-46383A Ophthalmic Solution Vehicle, 1 drop in each eye, 8 times a day, for 10 days Receives: Drug: AL-46383A Ophthalmic Solution Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained microbiological success at Day 5 or Day 7
Measured: Up to Day 18
Secondary outcomes (1)
Time to sustained microbiological success
Measured: Up to Day 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2009 (estimated)
- Study startJun 2009
- Primary completionJul 2010
- Study completionJul 2010
Why it stopped: Internal business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenoviral ConjunctivitisStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 452 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sally Scheib, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00901693
- Sponsor's protocol ID
- C-07-53
- Status last verified
- May 2014
- First submitted
- 8 May 2009
- Last updated
- 22 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Efficacy and Safety of AL-46383A Ophthalmic Solution for the Treatment of Adenoviral Conjunctivitis
- ClinicalTrials.gov ID
- NCT00901693
- Acronym / sponsor ID
- C-07-53
- Conditions
- Adenoviral Conjunctivitis
- Keywords
- pink eye, eye infection, conjunctivitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Internal business decision
- Enrolment
- 452 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 14 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 evaluate the safety and efficacy of AL-46383A Ophthalmic Solution for the treatment of adenoviral conjunctivitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AL-46383A | Experimental | Drug: AL-46383A Ophthalmic SolutionAL-46383A Ophthalmic Solution, 1 drop in each eye, 8 times a day for 10 days |
| Vehicle | Placebo comparator | Drug: AL-46383A Ophthalmic Solution VehicleAL-46383A Ophthalmic Solution Vehicle, 1 drop in each eye, 8 times a day, for 10 days |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- At least one eye must have EITHER a positive adenovirus test (using the Adeno Detector™ for Adenoviral Conjunctivitis, Rapid Pathogen Screening, Inc.) OR a positive clinical diagnosis assessed by the Adenoviral Clinical Diagnostic Checklist.
- Onset and development of ocular symptoms and/or signs of conjunctivitis ≤ 7 days prior to enrollment (Day 1) in either eye.
- Able to understand and sign an informed consent form that has been approved by an Institutional Review Board/ Independent Ethics Committee (IRB/IEC).
- Must agree to comply with the visit schedule and other requirements of the study.
- Females who are not pregnant and are not lactating. All females of childbearing potential (those who are not pre-menarcheal, not postmenopausal or surgically sterile) may participate only if they have a negative urine pregnancy test prior to randomization, and if they agree to use adequate birth control methods to prevent pregnancy throughout the study.
Key exclusion criteria (11 listed)
- Sub-epithelial infiltrates at the Day 1 visit in either eye.
- Corneal opacity or any corneal abnormality at the Day 1 visit in either eye.
- Contact lens wear during the course of the study. Participants requiring correction must have spectacles with appropriate correction.
- Only one sighted eye or vision in either eye not correctable to 0.6 or better logMAR (using ETDRS chart) at the Day 1 visit.
- Abnormal findings in the posterior pole of the retina or any media opacity found in a dilated fundus examination at the Day 1 (Screening/ Baseline) visit.
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-46383A Ophthalmic Solution | Drug | AL-46383A |
| AL-46383A Ophthalmic Solution Vehicle | Drug | Vehicle |
Primary outcome
Sustained microbiological success at Day 5 or Day 7
Time frame: Up to Day 18
1 secondary outcome
Time to sustained microbiological success
Time frame: Up to Day 18
Results and safety
The study was stopped early (reason given: Internal business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2014.
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.
Sally Scheib study director
Alcon Research
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AL-46383A Ophthalmic Solution in people with Adenoviral Conjunctivitis, 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 6 inclusion and 11 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: stopped early, as of the sponsor's last update on 22 May 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 was stopped early (reason given: Internal business decision). Results are not available in the source record.
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?
Sustained microbiological success at Day 5 or Day 7 (time frame: Up to Day 18). 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 22 May 2014.