Allergic ConjunctivitisPhase 3NCT01698814
A Six-Week Safety Study of an Investigational Ophthalmic Solution
A Phase 3 study testing AL-4943A Ophthalmic Solution in people with Allergic Conjunctivitis, run by Alcon Research.
Trial summary
The purpose of this study was to evaluate the ocular safety of an investigational ophthalmic solution in subjects 2 years of age and older with asymptomatic eyes when administered once daily in both eyes for up to 6 weeks. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Allergic Conjunctivitis
- What is being tested?
- AL-4943A Ophthalmic Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 518 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Jan 2013
- Phase
- Phase 3
- 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 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Able and willing to comply with study protocol and follow protocol instructions.
- Adequate birth control methods for the duration of the study.
- Best-corrected visual acuity (BCVA) of 55 or greater in each eye.
- Willing to avoid contact lens wear during each of the study visits; contact lens wear also should be stable and consistent for 1 month prior to Visit 1 and expected to remain the same for the study duration.
- Willing and able to sign an Informed Consent form.
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- Women of childbearing potential that are pregnant, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
- Evidence of contact lens care solution related ocular surface damage or giant papillary conjunctivitis (GPC).
- Any ocular infection (bacterial, viral or fungal) or history of ocular Herpes (simplex or zoster) or adenoviral infection in either eye or have had any ocular infection within 30 days prior to Visit 1.
- Using systemic medication(s) on a chronic dosing regimen for less than 30 days or changed dosage of this medication within 30 days prior to Visit 1.
- Current or past history of glaucoma or ocular hypertension.
- History of retinal detachment, diabetic retinopathy, or progressive retinal disease.
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- Presence of ocular conditions that may affect the study outcomes.
- Corneal conditions affecting the corneal structure.
- History or evidence of any ocular surgical procedure within 1 year prior to Visit 1.
- Current or recent medical conditions that, in the opinion of the Investigator, would preclude safe participation in the study.
- Prior, current, or anticipated use of ophthalmic agents other than investigational product during study participation.
- Participation in any investigational study within 30 days prior to Visit 1 or concomitantly with this study.
- Known contraindications or hypersensitivities to any of the study medications or their components.
- Other protocol-specified exclusion criteria may apply.
About this study
Official title: A Multicenter, Randomized, Double-Masked, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of AL-4943A Ophthalmic Solution Administered Once Daily
The purpose of this study was to evaluate the ocular safety of an investigational ophthalmic solution in subjects 2 years of age and older with asymptomatic eyes when administered once daily in both eyes for up to 6 weeks.
- Conditions
- Allergic Conjunctivitis
- Being tested
- AL-4943A Ophthalmic Solution, AL-4943A Ophthalmic Solution Vehicle
- Keywords
- ocular safety, allergic conjunctivitis
- Medical subject headings
- Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AL-4943A Ophthalmic SolutionDrug
AL-4943A Ophthalmic Solution VehicleDrug
Inactive ingredients used as placebo
| Study group | Role | What they receive |
|---|---|---|
| AL-4943A | Experimental | AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks Receives: Drug: AL-4943A Ophthalmic Solution |
| AL-4943A Vehicle | Placebo comparator | AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks Receives: Drug: AL-4943A Ophthalmic Solution Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
An adverse event was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.
Measured: An average of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionJan 2013
- Study completionJan 2013
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 Allergic 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 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 518 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Terri Pasquine, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01698814
- Sponsor's protocol ID
- C-12-028
- Status last verified
- Feb 2014
- First submitted
- 27 Sep 2012
- Last updated
- 27 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Masked, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of AL-4943A Ophthalmic Solution Administered Once Daily
- ClinicalTrials.gov ID
- NCT01698814
- Acronym / sponsor ID
- C-12-028
- Conditions
- Allergic Conjunctivitis
- Keywords
- ocular safety, allergic conjunctivitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 518 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 3 Oct 2012 (estimated)
- Results
- Posted 28 Feb 2014
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 ocular safety of an investigational ophthalmic solution in subjects 2 years of age and older with asymptomatic eyes when administered once daily in both eyes for up to 6 weeks.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AL-4943A | Experimental | Drug: AL-4943A Ophthalmic SolutionAL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks |
| AL-4943A Vehicle | Placebo comparator | Drug: AL-4943A Ophthalmic Solution VehicleAL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Able and willing to comply with study protocol and follow protocol instructions.
- Adequate birth control methods for the duration of the study.
- Best-corrected visual acuity (BCVA) of 55 or greater in each eye.
- Willing to avoid contact lens wear during each of the study visits; contact lens wear also should be stable and consistent for 1 month prior to Visit 1 and expected to remain the same for the study duration.
- Willing and able to sign an Informed Consent form.
Key exclusion criteria (14 listed)
- Women of childbearing potential that are pregnant, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
- Evidence of contact lens care solution related ocular surface damage or giant papillary conjunctivitis (GPC).
- Any ocular infection (bacterial, viral or fungal) or history of ocular Herpes (simplex or zoster) or adenoviral infection in either eye or have had any ocular infection within 30 days prior to Visit 1.
- Using systemic medication(s) on a chronic dosing regimen for less than 30 days or changed dosage of this medication within 30 days prior to Visit 1.
- Current or past history of glaucoma or ocular hypertension.
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-4943A Ophthalmic Solution | Drug | AL-4943A |
| AL-4943A Ophthalmic Solution VehicleInactive ingredients used as placebo | Drug | AL-4943A Vehicle |
Primary outcome
Adverse Events
Time frame: An average of 6 weeks
An adverse event was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2014.
- 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.
Terri Pasquine study director
Alcon Research
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AL-4943A Ophthalmic Solution in people with Allergic 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 14 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 27 Mar 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 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?
Yes. Results are posted in the registry (first posted 28 Feb 2014). 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?
Adverse Events (time frame: An average of 6 weeks). 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 27 Mar 2014.