Allergic ConjunctivitisPhase 3NCT00770133

Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Acute Allergic Conjunctivitis.

A Phase 3 study testing Ketotifen/naphazoline, Naphazoline and Ketotifen in people with Allergic Conjunctivitis, run by Bausch & Lomb Incorporated at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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, Naphazoline and Ketotifen
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 141 participants
Where: 1 siteUnited States
Study dates: Feb 2010to Jun 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 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 for 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

Other trials in United States

About this study

Official title: A Multi-center, Double-masked, Randomized, Placebo-controlled Evaluation of the Onset and Duration of Action of KetoNaph Ophthalmic Solution in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis.

Conditions: Allergic Conjunctivitis
Being tested: Ketotifen/naphazoline, Naphazoline, Ketotifen, 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 fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.
NaphazolineDrug
One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.
KetotifenDrug
One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.
VehicleDrug
One drop of vehicle ophthalmic solution at visit 3 and visit 4.

Study groups in NCT00770133
Study group	Role	What they receive
Ketotifen/naphazoline	Experimental	Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Receives: Drug: Ketotifen/naphazoline
Vehicle	Placebo comparator	Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Receives: Drug: Vehicle
Naphazoline	Active comparator	Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Receives: Drug: Naphazoline
Ketotifen	Active comparator	Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Receives: Drug: Ketotifen

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 Redness
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 the same 0-4 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
Episcleral Redness
Episcleral hyperemia (redness) was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Assessments were made using the same 0-4 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
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 participant 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 hTearing
Tearing was evaluated by the participant at 7, 15, and 20 minutes post challenge. 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 Discharge
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.

Feb 2010Jun 2010

First posted9 Oct 2008 (estimated)
Study startFeb 2010
Primary completionApr 2010
Study completionJun 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 141 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00770133
Sponsor's protocol ID: 572
Status last verified: Oct 2020
First submitted: 8 Oct 2008
Last updated: 27 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED
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RecruitingObservational study
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All Allergic Conjunctivitis trials

Study at a glance

From the registry record, last updated by the sponsor on 27 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 Evaluation of the Onset and Duration of Action of KetoNaph Ophthalmic Solution in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis.
ClinicalTrials.gov ID: NCT00770133
Acronym / sponsor ID: 572
Conditions: Allergic Conjunctivitis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 141 participants (actual)
Lead sponsor: Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
Study start: Feb 2010
Primary completion: Apr 2010 (actual)
Study completion: Jun 2010 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Ketotifen/naphazoline	Experimental	Drug: Ketotifen/naphazolineKetotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
Vehicle	Placebo comparator	Drug: VehicleVehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
Naphazoline	Active comparator	Drug: NaphazolineNaphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
Ketotifen	Active comparator	Drug: KetotifenKetotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.

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 for 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 fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.	Drug	Ketotifen/naphazoline
NaphazolineOne drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.	Drug	Naphazoline
KetotifenOne drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.	Drug	Ketotifen
VehicleOne drop of vehicle ophthalmic solution 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 Redness
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 hTearing
Time frame: 7, 15, and 20 minutes post challenge at 14 days
Percentage of Eyes With Ocular Mucus Discharge
Time frame: 7, 15, and 20 minutes post challenge at 14 days

Results and safety

Results posted to the registry on 27 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ketotifen/Naphazoline	35	32
Ketotifen	36	35
Naphazoline	35	32
Vehicle	35	32

Primary outcome: Ocular Itching

Time frame: 3, 5, and 7 minutes post challenge at 14 days. Mean (Standard Deviation). Unit: score on a scale

Measure	Ketotifen/Naphazoline n = 34	Ketotifen n = 36	Naphazoline n = 34	Vehicle n = 35
3 minutes post-challenge	0.43 (0.62)	0.40 (0.65)	1.60 (0.92)	1.81 (0.88)
5 minutes post-challenge	0.65 (0.76)	0.59 (0.79)	1.67 (1.01)	1.96 (0.94)
7 minutes post-challenge	0.60 (0.83)	0.56 (0.87)	1.54 (0.96)	1.84 (1.01)

Population analysed: The intent to treat population consisted of participants who were randomized, received investigational treatment, and had at least 1 post-challeng assessment.

Primary outcome: Conjunctival Redness

Time frame: 7, 15, and 20 minutes post challenge at 14 days. Mean (Standard Deviation). Unit: score on a scale

Measure	Ketotifen/Naphazoline n = 34	Ketotifen n = 36	Naphazoline n = 34	Vehicle n = 35
7 minutes post-challeng	0.89 (0.87)	1.49 (0.83)	1.63 (0.84)	2.06 (0.77)
15 minutes post-challenge	1.13 (1.00)	1.80 (0.87)	1.69 (0.89)	2.26 (0.78)
20 minutes post-challenge	1.13 (1.02)	1.88 (0.89)	1.57 (0.92)	2.18 (0.85)

Population analysed: The intent to treat population consisted of participants who were randomized, received investigational treatment, and had at least 1 post-challeng assessment.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 14 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ketotifen/Naphazoline	0 of 35 (0%)	0 of 35 (0%)	Not reported
Ketotifen	0 of 36 (0%)	0 of 36 (0%)	Not reported
Naphazoline	0 of 35 (0%)	0 of 35 (0%)	Not reported
Vehicle	0 of 35 (0%)	0 of 35 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Allergic Conjunctivitis

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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.

Laura Trusso study director

Bausch & Lomb Incorporated

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, Naphazoline and Ketotifen 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 27 Oct 2020. 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?

On the ClinicalTrials.gov record for NCT00770133.

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 Oct 2020.