Allergic ConjunctivitisPhase 1NCT01326858
Safety and Comfort of AL-4943A Ophthalmic Solution
A Phase 1 study testing Olopatadine hydrochloride ophthalmic solution, 0.7% and Ketotifen fumarate ophthalmic solution, 0.025% in people with Allergic Conjunctivitis, run by Alcon Research.
Trial summary
The purpose of this study is to assess the ocular comfort and safety of olopatadine hydrochloride opthalmic solution. 0.7%. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Allergic Conjunctivitis
- What is being tested?
- Olopatadine hydrochloride ophthalmic solution, 0.7% and Ketotifen fumarate ophthalmic solution, 0.025%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Apr 2011to Jun 2011
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to be dosed in both eyes, to follow instructions, and willing and able to attend required study visits.
- Negative urine pregnancy test if female of childbearing potential and use adequate birth control throughout the study period.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- History or clinical evidence of ocular herpes simplex or ocular herpes zoster infectious disease.
- History of any clinically significant external ocular disease within 30 days of the start of the study.
- Presence of active blepharitis, active meibomian gland dysfunction, active rosacea affecting the ocular surface/lid margin, active or chronic follicular conjunctivitis, preauricular adenopathy, or any other ocular or periocular abnormality that may affect the study outcomes.
- Other protocol-defined exclusion criteria may apply.
About this study
Official title: A Randomized, Double-Masked, Crossover Study to Evaluate the Safety and Comfort of AL-4943A Ophthalmic Solution, 0.7%
The purpose of this study is to assess the ocular comfort and safety of olopatadine hydrochloride opthalmic solution. 0.7%.
Read the detailed description
In this 3-treatment, 3-period, 6-sequence crossover study, each subject will receive all 3 products in randomized order, 1 product at a time, with a washout period of 24 hours between treatment periods. Following instillation of study medication, subjects will complete a 3-minute discomfort profile.
- Conditions
- Allergic Conjunctivitis
- Being tested
- Olopatadine hydrochloride ophthalmic solution, 0.7%, Olopatadine hydrochloride ophthalmic solution vehicle, Ketotifen fumarate ophthalmic solution, 0.025%
- Keywords
- Ocular discomfort, AL-4943A Ophthalmic Solution
- Medical subject headings
- Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olopatadine hydrochloride ophthalmic solution, 0.7%Drug
Also called AL-4943A
Treatment A
Olopatadine hydrochloride ophthalmic solution vehicleDrug
Treatment B, inactive ingredients used as placebo
Ketotifen fumarate ophthalmic solution, 0.025%Drug
Also called Zaditor®
Treatment C
| Study group | Role | What they receive |
|---|---|---|
| Olopatadine, 0.7% | Experimental | Olopatadine hydrochloride ophthalmic solution, 0.7%, 1 drop instilled in each eye, 1 dose, in Period 1, followed by olopatadine hydrochloride ophthalmic vehicle and ketotifen fumarate ophthalmic solution, 0.025%, Periods 2 and 3, as randomized Receives: Drug: Olopatadine hydrochloride ophthalmic solution, 0.7%; Drug: Olopatadine hydrochloride ophthalmic solution vehicle; Drug: Ketotifen fumarate ophthalmic solution, 0.025% |
| Vehicle | Placebo comparator | Olopatadine hydrochloride ophthalmic solution vehicle, 1 drop instilled in each eye, 1 dose, in Period 1, followed by olopatadine hydrochloride ophthalmic solution, 0.7% and ketotifen fumarate ophthalmic solution, 0.025%, Periods 2 and 3, as randomized Receives: Drug: Olopatadine hydrochloride ophthalmic solution, 0.7%; Drug: Olopatadine hydrochloride ophthalmic solution vehicle; Drug: Ketotifen fumarate ophthalmic solution, 0.025% |
| Zaditor | Active comparator | Ketotifen fumarate ophthalmic solution, 0.025%, 1 drop instilled in each eye, 1 dose, in Period 1, followed by olopatadine hydrochloride ophthalmic solution, 0.7% and olopatadine hydrochloride ophthalmic solution vehicle, Periods 2 and 3, as randomized Receives: Drug: Olopatadine hydrochloride ophthalmic solution, 0.7%; Drug: Olopatadine hydrochloride ophthalmic solution vehicle; Drug: Ketotifen fumarate ophthalmic solution, 0.025% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak discomfort score over a 3-minute period after drop instillation
Ocular discomfort as measured by Visual Analog Scale (VAS) with 0=none to 50=severe, was assessed by subjects every 30 seconds between 0 to 180 seconds after drop instillation (at 0, 30, 60, 90, 120, 150, and 180 seconds). Peak discomfort (maximum observed VAS discomfort score over the 3-minute period) for each subject in each period was analyzed.
Measured: Up to Day 3
Secondary outcomes (2)
Ocular Symptoms
Ocular symptoms (burning, stinging, tearing, blurring, and stickiness) assessed by the subject after instillation of drop as a single score where 0=none to 9=severe.
Measured: Up to Day 3
Product Acceptability
Product Acceptability assessed by the subject after instillation of drop as a single score where 0=very acceptable and 100=not acceptable.
Measured: Up to Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Abhijit Narvekar, MS, MBBS, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01326858
- Sponsor's protocol ID
- C-10-127
- Status last verified
- Feb 2015
- First submitted
- 30 Mar 2011
- Last updated
- 3 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Masked, Crossover Study to Evaluate the Safety and Comfort of AL-4943A Ophthalmic Solution, 0.7%
- ClinicalTrials.gov ID
- NCT01326858
- Acronym / sponsor ID
- C-10-127
- Conditions
- Allergic Conjunctivitis
- Keywords
- Ocular discomfort, AL-4943A Ophthalmic Solution
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 31 Mar 2011 (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 assess the ocular comfort and safety of olopatadine hydrochloride opthalmic solution. 0.7%.
Detailed description
In this 3-treatment, 3-period, 6-sequence crossover study, each subject will receive all 3 products in randomized order, 1 product at a time, with a washout period of 24 hours between treatment periods. Following instillation of study medication, subjects will complete a 3-minute discomfort profile.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Olopatadine, 0.7% | Experimental | Drug: Olopatadine hydrochloride ophthalmic solution, 0.7%, Drug: Olopatadine hydrochloride ophthalmic solution vehicle, Drug: Ketotifen fumarate ophthalmic solution, 0.025%Olopatadine hydrochloride ophthalmic solution, 0.7%, 1 drop instilled in each eye, 1 dose, in Period 1, followed by olopatadine hydrochloride ophthalmic vehicle and ketotifen fumarate ophthalmic solution, 0.025%, Periods 2 and 3, as randomized |
| Vehicle | Placebo comparator | Drug: Olopatadine hydrochloride ophthalmic solution, 0.7%, Drug: Olopatadine hydrochloride ophthalmic solution vehicle, Drug: Ketotifen fumarate ophthalmic solution, 0.025%Olopatadine hydrochloride ophthalmic solution vehicle, 1 drop instilled in each eye, 1 dose, in Period 1, followed by olopatadine hydrochloride ophthalmic solution, 0.7% and ketotifen fumarate ophthalmic solution, 0.025%, Periods 2 and 3, as randomized |
| Zaditor | Active comparator | Drug: Olopatadine hydrochloride ophthalmic solution, 0.7%, Drug: Olopatadine hydrochloride ophthalmic solution vehicle, Drug: Ketotifen fumarate ophthalmic solution, 0.025%Ketotifen fumarate ophthalmic solution, 0.025%, 1 drop instilled in each eye, 1 dose, in Period 1, followed by olopatadine hydrochloride ophthalmic solution, 0.7% and olopatadine hydrochloride ophthalmic solution vehicle, Periods 2 and 3, as randomized |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able to be dosed in both eyes, to follow instructions, and willing and able to attend required study visits.
- Negative urine pregnancy test if female of childbearing potential and use adequate birth control throughout the study period.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (4 listed)
- History or clinical evidence of ocular herpes simplex or ocular herpes zoster infectious disease.
- History of any clinically significant external ocular disease within 30 days of the start of the study.
- Presence of active blepharitis, active meibomian gland dysfunction, active rosacea affecting the ocular surface/lid margin, active or chronic follicular conjunctivitis, preauricular adenopathy, or any other ocular or periocular abnormality that may affect the study outcomes.
- 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 |
|---|---|---|
| Olopatadine hydrochloride ophthalmic solution, 0.7%Also: AL-4943ATreatment A | Drug | Olopatadine, 0.7%, Vehicle, Zaditor |
| Olopatadine hydrochloride ophthalmic solution vehicleTreatment B, inactive ingredients used as placebo | Drug | Olopatadine, 0.7%, Vehicle, Zaditor |
| Ketotifen fumarate ophthalmic solution, 0.025%Also: Zaditor®Treatment C | Drug | Olopatadine, 0.7%, Vehicle, Zaditor |
Primary outcome
Peak discomfort score over a 3-minute period after drop instillation
Time frame: Up to Day 3
Ocular discomfort as measured by Visual Analog Scale (VAS) with 0=none to 50=severe, was assessed by subjects every 30 seconds between 0 to 180 seconds after drop instillation (at 0, 30, 60, 90, 120, 150, and 180 seconds). Peak discomfort (maximum observed VAS discomfort score over the 3-minute period) for each subject in each period was analyzed.
2 secondary outcomes
Ocular Symptoms
Time frame: Up to Day 3
Product Acceptability
Time frame: Up to Day 3
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 3 Mar 2015.
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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.
Abhijit Narvekar, MS, MBBS study director
Alcon Research
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Olopatadine hydrochloride ophthalmic solution, 0.7% and Ketotifen fumarate ophthalmic solution, 0.025% 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 3 inclusion and 4 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 3 Mar 2015. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Peak discomfort score over a 3-minute period after drop instillation (time frame: Up to Day 3). 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 3 Mar 2015.