Allergic ConjunctivitisPhase 3NCT01159015
Study Evaluating the Safety of KetoNaph Ophthalmic Solution in Healthy Volunteers
A Phase 3 study testing KetoNaph in people with Allergic Conjunctivitis, run by Bausch & Lomb Incorporated.
Trial summary
This study is being conducted to evaluate the safety of KetoNaph ophthalmic solution in healthy adult subjects and in pediatric subjects with a history or family history of ocular allergy. 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?
- KetoNaph
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 534 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to Oct 2010
- 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
- Subjects less than 18 years of age, have either a history or family history of ocular allergy.
- ocular health within normal limits, including a calculated best-corrected visual acuity of 0.3 logMar or better, in each eye. For subjects under 10 years old who are developmentally unable to use the ETDRS chart, visual acuity will be made using the LEA symbols. For these subjects, 20-foot Snellen equivalent units of 20/63 or better in both eyes will be required.
Who cannot join
- Contraindications or sensitivities to the use of any of the investigational product(s) or their components.
- Subjects less than 18 years of age that have had symptoms and/or signs of allergic conjunctivitis/rhinitis and/or treatment with topical or systemic anti-allergy therapy, or have had a history of ragweed hypersensitivity during the 21-day period prior to visit 1.
- Surgical intervention within three months prior to Visit 1 or during the refractive surgery within the past 6 months.
- A known history of retinal detachment, diabetic retinopathy, or active retinal disease;
- An active ocular infection (bacterial, viral or fungal
- Use of any topical ophthalmic agents other than investigational products during study participation or within 5 days of beginning study treatment.
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- Current or anticipated use of contact lenses during study participation or within 5 days of beginning study treatment.
- Current, prior (within 14 days of beginning study treatment) or anticipated use of systemic corticosteroids, and/or any other systemic medications which the Investigator feels may confound study data or interfere with the subject's study participation. Prior (within 21 days of beginning study treatment), current or anticipated use of any topical (including nasal) or systemic anti-allergy medications.
- Intraocular pressure (IOP) that is less than 5 mmHg or greater than 22 mmHg or have a normal IOP with a diagnosis of glaucoma.
About this study
Official title: A Multi-center, Double-masked, Randomized, Placebo-controlled, Parallel-group Study Evaluating the Safety of KetoNaph Ophthalmic Solution in Healthy, Normal Volunteers
This study is being conducted to evaluate the safety of KetoNaph ophthalmic solution in healthy adult subjects and in pediatric subjects with a history or family history of ocular allergy.
- Conditions
- Allergic Conjunctivitis
- Being tested
- KetoNaph, Vehicle
- Medical subject headings
- Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetoNaphDrug
Ophthalmic Solution administered BID for 6 weeks
VehicleDrug
Vehicle of KetoNaph ophthalmic solution administered bid for six weeks
| Study group | Role | What they receive |
|---|---|---|
| KetoNaph | Experimental | KetoNaph Ophthalmic Solution Receives: Drug: KetoNaph |
| Vehicle | Placebo comparator | Vehicle of KetoNaph Ophthalmic Solution Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With at Least One Adverse Event.
An adverse event was defined as unfavorable and unintended sign, symptom, or disease temporally associated with the use of a test article, whether or not considered related to test article.
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionSep 2010
- Study completionOct 2010
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.
- 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
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 534 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tuyen Ong, MD, Principal investigator, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01159015
- Sponsor's protocol ID
- 586
- Status last verified
- Oct 2020
- First submitted
- 6 Jul 2010
- Last updated
- 5 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Double-masked, Randomized, Placebo-controlled, Parallel-group Study Evaluating the Safety of KetoNaph Ophthalmic Solution in Healthy, Normal Volunteers
- ClinicalTrials.gov ID
- NCT01159015
- Acronym / sponsor ID
- 586
- Conditions
- Allergic Conjunctivitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 534 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 9 Jul 2010 (estimated)
- Results
- Posted 14 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to evaluate the safety of KetoNaph ophthalmic solution in healthy adult subjects and in pediatric subjects with a history or family history of ocular allergy.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KetoNaph | Experimental | Drug: KetoNaphKetoNaph Ophthalmic Solution |
| Vehicle | Placebo comparator | Drug: VehicleVehicle of KetoNaph Ophthalmic Solution |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects less than 18 years of age, have either a history or family history of ocular allergy.
- ocular health within normal limits, including a calculated best-corrected visual acuity of 0.3 logMar or better, in each eye. For subjects under 10 years old who are developmentally unable to use the ETDRS chart, visual acuity will be made using the LEA symbols. For these subjects, 20-foot Snellen equivalent units of 20/63 or better in both eyes will be required.
Key exclusion criteria (9 listed)
- Contraindications or sensitivities to the use of any of the investigational product(s) or their components.
- Subjects less than 18 years of age that have had symptoms and/or signs of allergic conjunctivitis/rhinitis and/or treatment with topical or systemic anti-allergy therapy, or have had a history of ragweed hypersensitivity during the 21-day period prior to visit 1.
- Surgical intervention within three months prior to Visit 1 or during the refractive surgery within the past 6 months.
- A known history of retinal detachment, diabetic retinopathy, or active retinal disease;
- An active ocular infection (bacterial, viral or fungal
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 |
|---|---|---|
| KetoNaphOphthalmic Solution administered BID for 6 weeks | Drug | KetoNaph |
| VehicleVehicle of KetoNaph ophthalmic solution administered bid for six weeks | Drug | Vehicle |
Primary outcome
Percentage of Participants With at Least One Adverse Event.
Time frame: 42 days
An adverse event was defined as unfavorable and unintended sign, symptom, or disease temporally associated with the use of a test article, whether or not considered related to test article.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- 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.
Tuyen Ong, MD principal investigator
Bausch & Lomb Incorporated
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing KetoNaph in people with Allergic Conjunctivitis, run by Bausch & Lomb Incorporated.
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 2 inclusion and 9 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 5 Oct 2020. 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 14 Sep 2020). 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?
Percentage of Participants With at Least One Adverse Event. (time frame: 42 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 5 Oct 2020.