Allergic ConjunctivitisPhase 3NCT00769886
Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Allergic Conjunctivitis.
A Phase 3 study testing Ketotifen/naphazoline, Ketotifen and Naphazoline in people with Allergic Conjunctivitis, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
The purpose of this study is to establish the safety and efficacy of ketotifen/naphazoline ophthalmic solution compared to vehicle and its individual components in alleviating the signs and symptoms of conjunctival allergen challenge (CAC)-induced allergic conjunctivitis. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Allergic Conjunctivitis
- What is being tested?
- Ketotifen/naphazoline, Ketotifen and Naphazoline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Jun 2009
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Positive history of ocular allergies and positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within the past 24 months.
- Calculated best-corrected visual acuity of 0.7 logMAR or better in each eye as measured using the ETDRS chart.
- Positive bilateral conjunctival allergen challenge(CAC)reaction within 10 minutes of instillation of the last titration of allergen at visit 1.
- Positive bilateral CAC reaction in at least 2 out of 3 time points at visit 2.
Who cannot join
- Known contraindications or sensitivities to the study medication or its components.
- Any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters.
- Use of disallowed medications during the period indicated prior to study enrollment or during the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ophthalmic Research Consultants, Inc.
North Andover, Massachusetts, 01845
About this study
Official title: A Multi-Center, Double-Masked, Randomized, Vehicle and Active Controlled Evaluation of the Onset and Duration of Action of KetoNaph Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Acute Allergic Conjunctivitis
The purpose of this study is to establish the safety and efficacy of ketotifen/naphazoline ophthalmic solution compared to vehicle and its individual components in alleviating the signs and symptoms of conjunctival allergen challenge (CAC)-induced allergic conjunctivitis.
- Conditions
- Allergic Conjunctivitis
- Being tested
- Ketotifen/naphazoline, Ketotifen, Naphazoline, 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.
Ketotifen/naphazolineDrug
One drop of ketotifen/naphazoline in study eye at visit 3 and visit 4.
KetotifenDrug
One drop of Ketotifen in study eye at visit 3 and visit 4.
NaphazolineDrug
One drop of naphazoline in study eye at vist 3 and visit 4.
VehicleDrug
One drop of vehicle in study eye at visit 3 and visit 4.
| Study group | Role | What they receive |
|---|---|---|
| KetoNaph | Experimental | KetoNaph (ketotifen fumarate 0.025%, naphazoline HCl 0.05%) ophthalmic solution Receives: Drug: Ketotifen/naphazoline |
| Naphazoline | Active comparator | Naphazoline HCl 0.05% ophthalmic solution Receives: Drug: Naphazoline |
| Ketotifen | Active comparator | Ketotifen fumarate 0.025% ophthalmic solution Receives: Drug: Ketotifen |
| 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.
Ocular Itching
Ocular itching was evaluated by the participant at 3, 5, and 7 minutes post challenge. Assessments were made using a 0-4 numerical analog scale, allowing 0.5-unit increments (but disallowing 0.25-unit increments), where: 0.0 = None and 4.0 = Incapacitating itch with an irresistible urge to rub.
Measured: 3, 5, and 7 minutes post challenge at 14 days
Conjunctival Hyperemia
Conjunctival hyperemia was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Assessments were completed using a 0-4 numerical analog scale, allowing 0.5-unit increments, where: 0.0 = None and 4.0 = Extremely severe.
Measured: 7, 15, and 20 minutes post challenge at 14 days
Secondary outcomes (6)
Ciliary Redness
Ciliary hyperemia (redness) was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Assessments were made using a 0-4 scale, allowing 0.5- unit increments, with 0.0 = None and 4.0 = Extremely severe.
Measured: 7, 15, and 20 minutes post challenge at 14 days
Episcleral Redness
Episcleral hyperemia (redness) was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Assessments were made using a 0-4 scale, allowing 0.5- unit increments, with 0.0 = None and 4.0 = Extremely severe.
Measured: 7, 15, and 20 minutes post challenge at 14 days
Chemosis
Chemosis was evaluated by the Investigator at 7, 15, and 20 minutes post challenge on a 0-4 numerical analog scale, allowing 0.5-unit increments, where: 0.0 = None and 4.0 = Extremely severe.
Measured: 7, 15, and 20 minutes post challenge at 14 days
Eyelid Swelling
Lid swelling was evaluated by the subject at 7, 15, and 20 minutes post challenge on a 0- 3 numerical analog scale, with 0.5-unit increments disallowed, where: 0.0 = None and 3.0 = Severe.
Measured: 7, 15, and 20 minutes post challenge at 14 days
Percentage of Eyes With Tearing
Tearing was evaluated by the subject at 7, 15, and 20 minutes post challenge (absent or present). Tearing was recorded as either absent or present.
Measured: 7, 15, and 20 minutes post challenge at 14 days
Percentage of Eyes With Ocular Mucus Drainage
Ocular mucous discharge was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Mucous discharged was recorded as either absent or present.
Measured: 7, 15, and 20 minutes post challenge at 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2008
- Study completionJun 2009
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00769886
- Sponsor's protocol ID
- 571
- Status last verified
- Oct 2020
- First submitted
- 8 Oct 2008
- Last updated
- 3 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Double-Masked, Randomized, Vehicle and Active Controlled Evaluation of the Onset and Duration of Action of KetoNaph Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Acute Allergic Conjunctivitis
- ClinicalTrials.gov ID
- NCT00769886
- Acronym / sponsor ID
- 571
- Conditions
- Allergic Conjunctivitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 9 Oct 2008 (estimated)
- Results
- Posted 27 Oct 2020
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 establish the safety and efficacy of ketotifen/naphazoline ophthalmic solution compared to vehicle and its individual components in alleviating the signs and symptoms of conjunctival allergen challenge (CAC)-induced allergic conjunctivitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| KetoNaph | Experimental | Drug: Ketotifen/naphazolineKetoNaph (ketotifen fumarate 0.025%, naphazoline HCl 0.05%) ophthalmic solution |
| Naphazoline | Active comparator | Drug: NaphazolineNaphazoline HCl 0.05% ophthalmic solution |
| Ketotifen | Active comparator | Drug: KetotifenKetotifen fumarate 0.025% ophthalmic solution |
| Vehicle | Placebo comparator | Drug: VehicleVehicle of KetoNaph ophthalmic solution |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Positive history of ocular allergies and positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within the past 24 months.
- Calculated best-corrected visual acuity of 0.7 logMAR or better in each eye as measured using the ETDRS chart.
- Positive bilateral conjunctival allergen challenge(CAC)reaction within 10 minutes of instillation of the last titration of allergen at visit 1.
- Positive bilateral CAC reaction in at least 2 out of 3 time points at visit 2.
Key exclusion criteria (3 listed)
- Known contraindications or sensitivities to the study medication or its components.
- Any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters.
- Use of disallowed medications during the period indicated prior to study enrollment or during the study.
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 |
|---|---|---|
| Ketotifen/naphazolineOne drop of ketotifen/naphazoline in study eye at visit 3 and visit 4. | Drug | KetoNaph |
| KetotifenOne drop of Ketotifen in study eye at visit 3 and visit 4. | Drug | Ketotifen |
| NaphazolineOne drop of naphazoline in study eye at vist 3 and visit 4. | Drug | Naphazoline |
| VehicleOne drop of vehicle in study eye at visit 3 and visit 4. | Drug | Vehicle |
Primary outcome
Ocular Itching
Time frame: 3, 5, and 7 minutes post challenge at 14 days
Ocular itching was evaluated by the participant at 3, 5, and 7 minutes post challenge. Assessments were made using a 0-4 numerical analog scale, allowing 0.5-unit increments (but disallowing 0.25-unit increments), where: 0.0 = None and 4.0 = Incapacitating itch with an irresistible urge to rub.
Conjunctival Hyperemia
Time frame: 7, 15, and 20 minutes post challenge at 14 days
Conjunctival hyperemia was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Assessments were completed using a 0-4 numerical analog scale, allowing 0.5-unit increments, where: 0.0 = None and 4.0 = Extremely severe.
6 secondary outcomes
Ciliary Redness
Time frame: 7, 15, and 20 minutes post challenge at 14 days
Episcleral Redness
Time frame: 7, 15, and 20 minutes post challenge at 14 days
Chemosis
Time frame: 7, 15, and 20 minutes post challenge at 14 days
Eyelid Swelling
Time frame: 7, 15, and 20 minutes post challenge at 14 days
Percentage of Eyes With Tearing
Time frame: 7, 15, and 20 minutes post challenge at 14 days
Percentage of Eyes With Ocular Mucus Drainage
Time frame: 7, 15, and 20 minutes post challenge at 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ketotifen/naphazoline, Ketotifen and Naphazoline in people with Allergic Conjunctivitis, run by Bausch & Lomb Incorporated at 1 site in United States.
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 3 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 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 27 Oct 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?
Ocular Itching (time frame: 3, 5, and 7 minutes post challenge at 14 days). The study lists 2 primary outcomes in all. 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 Apr 2024.