Allergic ConjunctivitisPhase 3NCT05579730

Evaluation of Brimonidine Tartrate/Ketotifen Fumarate Combination for the Treatment of Allergic Conjunctivitis

A Phase 3 study testing Brimonidine tartrate 0.025%/ketotifen fumarate 0.035%, Brimonidine Tartrate 0.025% and Ketotifen Fumarate 0.035% in people with Allergic Conjunctivitis, run by Bausch & Lomb Incorporated at 4 sites 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

To evaluate the efficacy of Combo (Drug Product Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Ophthalmic Solution) compared to its individual components and vehicle in a population of subjects with allergic conjunctivitis: Read more about this study

Who is it for?: Ages 10 years and older
Conditions the study is for: Allergic Conjunctivitis
What is being tested?: Brimonidine tartrate 0.025%/ketotifen fumarate 0.035%, Brimonidine Tartrate 0.025% and Ketotifen Fumarate 0.035%
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 188 participants
Where: 4 sitesUnited States
Study dates: 12 Oct 2022to 22 Jul 2023
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 10 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Subjects must:
be at least 10 years of age of either sex and any race;
provide written informed consent and sign a HIPAA form. Subjects who are under the age of 18 will need to sign an assent form as well as having a parent or legal guardian sign an informed consent;
be willing and able to follow all instructions and attend all study visits;
(If female and of childbearing potential) agree to have urine pregnancy testing performed at visits 2, 4a (must be negative) and at exit visit (Visit 5); must not be lactating; and must agree to use at least 1 medically acceptable form of birth control throughout the study duration, for at least 14 days prior to the first dose of investigational drug (Visit 4a) and for 1 month after the last dose of investigational drug (Visit 5). Acceptable forms of birth control are true abstinence (when this is in line with the preferred and usual lifestyle of the subject), spermicide with barrier, oral contraceptive, injectable or implantable method of contraception, transdermal contraceptive, intrauterine device, or surgical sterilization of male partner at least 3 months prior to the first dose of investigational drug (Visit 4a). Note: Women considered capable of becoming pregnant include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy);
(If male and with female partner of childbearing potential) must use at least 1 medically acceptable form of birth control. throughout the study duration, for at least 14 days prior to the first dose of investigational drug (Visit 4a) and for 1 month after the last dose of the study drug (Visit 5) Note: Acceptable forms of birth control are true abstinence (when this is in line with the preferred and usual lifestyle of the subject) or vasectomy at least 3 months prior to the first dose of investigational drug (Visit 4a). Without a vasectomy, must use condoms with spermicidal foam/gel/film/cream/suppository.

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have a history of ocular allergies and a positive skin test reaction to a seasonal (grass, ragweed, tree pollen) or perennial (cat dander, dog dander, dust mites, cockroach) allergen as confirmed by an allergic skin test conducted at Visit 1 or within the past 24 months;
have a calculated best-corrected visual acuity of 0.7 LogMar or better in each eye as measured using an ETDRS chart at Visit 2;
have a positive bilateral CAC reaction (defined as having scores of ≥ 2 for ocular itching and ≥ 2 for conjunctival redness) within 10 minutes of instillation of the last titration of allergen at Visit 2;
have a positive bilateral CAC reaction (defined as having scores of ≥ 2 for ocular itching and ≥ 2 for conjunctival redness) in at least 2 out of 3 timepoints at following the challenge at Visit 3;
be able and willing to discontinue wearing contact lenses for at least 72 hours prior to Visit 2 and during the study trial period.

Who cannot join

Subjects may not:
have known contraindications or sensitivities to the use of any of the investigational product(s) or their components;
have any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters (including but not limited to narrow angle glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis, pterygium, or a diagnosis of dry eye);
have had ocular surgical intervention within 3 months prior to enrollment (Visit 4a) and/or a history of refractive surgery within 6 months prior to enrollment (Visit 4a);
have a known history of retinal detachment, diabetic retinopathy, or progressive retinal disease;
have the presence of an active ocular infection (bacterial, viral or fungal), positive history of an ocular herpetic infection, or preauricular lymphadenopathy at any visit;

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manifest signs or symptoms of clinically active allergic conjunctivitis in either eye at the start of Visits 2, 3, or 4a (defined as a score of >0 for itching and/or >1 for conjunctival redness);
use any of the following disallowed medications during the period indicated prior to Visit 2 and agree not to use disallowed medications throughout the study:
7 Days
systemic or ocular H1 antihistamines, H1 antihistamine/mast-cell stabilizer drug combinations, H1 antihistamine-vasoconstrictor drug combinations,
decongestants,
immunotherapeutic agents,
monoamine oxidase inhibitors,
artificial tears,
eye whiteners (eg, vasoconstrictors),
lid scrubs,
mast cell stabilizers,
prostaglandins or prostaglandin derivatives,
ocular, topical, or systemic nonsteroidal anti-inflammatory drugs (NSAIDs);
Baby aspirin (81 mg) is allowed as long as a stable dose has been maintained for at least 30 days prior to Visit 1 and will continue to be maintained for the duration of the study.
14 Days
inhaled, ocular, topical, or systemic corticosteroids or mast cellstabilizers;
45 Days
depo-corticosteroids
2 Months
immunosuppressive or cancer chemotherapeutic agents
Note: Currently marketed over-the counter anti-allergy eyedrops (i.e., antihistamine/vasoconstrictor combination products like Visine-A®or Naphcon-A®) may be administered to subjects at the end of each visit, after all evaluations are completed;
8. have any significant illness (for example, any autoimmune disease requiring therapy, or severe cardiovascular disease [including arrhythmias]) the Investigator feels could be expected to interfere with the subject's safety or study parameters and/or put the subject at any unnecessary risk (includes but is not limited to poorly controlled hypertension or poorly controlled diabetes, a history of status asthmaticus, organ transplants, a known history of persistent moderate or severe asthma, or a known history of moderate to severe allergic asthmatic reactions to any of the study allergens);

Trial locations and contacts

4 sites in 1 country.

United States4 sites

101
Andover, Massachusetts, 01810
114
Lynchburg, Virginia, 24502
102
Memphis, Tennessee, 38119
103
Phoenix, Arizona, 85032

Other trials in United States

About this study

Official title: Evaluation of Combination Drug Product Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Ophthalmic Solution Compared to Its Components and Vehicle for the Treatment of Allergic Conjunctivitis in the Conjunctival Allergen Challenge Model

Conditions: Allergic Conjunctivitis
Being tested: Brimonidine tartrate 0.025%/ketotifen fumarate 0.035%, Brimonidine Tartrate 0.025%, Ketotifen Fumarate 0.035%, 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.

Brimonidine tartrate 0.025%/ketotifen fumarate 0.035%Drug
combination ophthalmic solution
Brimonidine Tartrate 0.025%Drug
ophthalmic Solution
Ketotifen Fumarate 0.035%Drug
ophthalmic Solution
VehicleDrug
ophthalmic Solution

Study groups in NCT05579730
Study group	Role	What they receive
Combination	Experimental	Brimonidine tartrate 0.025%/ketotifen fumarate 0.035% combination ophthalmic solution Receives: Drug: Brimonidine tartrate 0.025%/ketotifen fumarate 0.035%
Ketotifen fumarate	Active comparator	ketotifen fumarate 0.035% ophthalmic solution Receives: Drug: Ketotifen Fumarate 0.035%
Brimonidine tartrate	Active comparator	brimonidine tartrate 0.025% ophthalmic solution Receives: Drug: Brimonidine Tartrate 0.025%
Vehicle	Placebo comparator	vehicle 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 score (measured on a 0-4 unit scale, allowing half-unit increments; average score of the subject's two eyes) assessed by the subjects at 3 (±1), 5 (±1), and 7 (±1) minutes post-CAC.
Measured: Assessed at Visit 4b on day 1 (duration of action CAC at 8 hours post-instillation of study medication) and Visit 5 on day 15 (onset of action CAC at 15 minutes post-instillation of study medication).
Conjunctival Redness
Conjunctival redness score (measured on a 0-4unit scale, allowing half-unit increments; average score of the subject's two eyes) assessed by investigator at 7 (±1), 15 (±1), and 20 (±1) minutes post-CAC.
Measured: Assessed at Visit 4b on day 1 (duration of action CAC at 8 hours post-instillation of study medication) and Visit 5 on day 15 (onset of action CAC at 15 minutes post-instillation of study medication).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Oct 202222 Jul 2023

First posted14 Oct 2022
Study start12 Oct 2022
Primary completion22 Jul 2023
Study completion22 Jul 2023

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: 188 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05579730
Sponsor's protocol ID: 909
Status last verified: Jan 2025
First submitted: 6 Oct 2022
Last updated: 14 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: 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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A Study to Evaluate the Efficacy and Safety of Fel d 1 Monoclonal Antibodies in Adult and Pediatric Participants With Allergic Conjunctivitis Due to Cat Allergy
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RecruitingPhase 3
An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED
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Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
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All Allergic Conjunctivitis trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Combination Drug Product Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Ophthalmic Solution Compared to Its Components and Vehicle for the Treatment of Allergic Conjunctivitis in the Conjunctival Allergen Challenge Model
ClinicalTrials.gov ID: NCT05579730
Acronym / sponsor ID: 909
Conditions: Allergic Conjunctivitis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 188 participants (actual)
Lead sponsor: Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
Study start: 12 Oct 2022 (actual)
Primary completion: 22 Jul 2023 (actual)
Study completion: 22 Jul 2023 (actual)
First posted: 14 Oct 2022 (actual)
Results: Posted 14 Feb 2025

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
Combination	Experimental	Drug: Brimonidine tartrate 0.025%/ketotifen fumarate 0.035%Brimonidine tartrate 0.025%/ketotifen fumarate 0.035% combination ophthalmic solution
Ketotifen fumarate	Active comparator	Drug: Ketotifen Fumarate 0.035%ketotifen fumarate 0.035% ophthalmic solution
Brimonidine tartrate	Active comparator	Drug: Brimonidine Tartrate 0.025%brimonidine tartrate 0.025% ophthalmic solution
Vehicle	Placebo comparator	Drug: Vehiclevehicle ophthalmic solution

Who may qualify

Ages: 10 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (11 listed)

Subjects must:

Key exclusion criteria (28 listed)

Subjects may not:
7 Days
Baby aspirin (81 mg) is allowed as long as a stable dose has been maintained for at least 30 days prior to Visit 1 and will continue to be maintained for the duration of the study.
14 Days
45 Days

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
Brimonidine tartrate 0.025%/ketotifen fumarate 0.035%combination ophthalmic solution	Drug	Combination
Brimonidine Tartrate 0.025%ophthalmic Solution	Drug	Brimonidine tartrate
Ketotifen Fumarate 0.035%ophthalmic Solution	Drug	Ketotifen fumarate
Vehicleophthalmic Solution	Drug	Vehicle

Primary outcome

Ocular Itching
Time frame: Assessed at Visit 4b on day 1 (duration of action CAC at 8 hours post-instillation of study medication) and Visit 5 on day 15 (onset of action CAC at 15 minutes post-instillation of study medication).
Ocular itching score (measured on a 0-4 unit scale, allowing half-unit increments; average score of the subject's two eyes) assessed by the subjects at 3 (±1), 5 (±1), and 7 (±1) minutes post-CAC.
Conjunctival Redness
Time frame: Assessed at Visit 4b on day 1 (duration of action CAC at 8 hours post-instillation of study medication) and Visit 5 on day 15 (onset of action CAC at 15 minutes post-instillation of study medication).
Conjunctival redness score (measured on a 0-4unit scale, allowing half-unit increments; average score of the subject's two eyes) assessed by investigator at 7 (±1), 15 (±1), and 20 (±1) minutes post-CAC.

Results and safety

Results posted to the registry on 14 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Combination	47	45
Ketotifen Fumarate	48	45
Brimonidine Tartrate	47	47
Vehicle	46	44

Primary outcome: Ocular Itching

Time frame: Assessed at Visit 4b on day 1 (duration of action CAC at 8 hours post-instillation of study medication) and Visit 5 on day 15 (onset of action CAC at 15 minutes post-instillation of study medication).. Mean (Standard Error). Unit: score on a scale

Measure	Combination n = 47	Ketotifen Fumarate n = 48	Brimonidine Tartrate n = 47	Vehicle n = 46
Visit 4b, 3 min Post-CAC	1.176 (0.1464)	1.708 (0.1487)	2.426 (0.1330)	2.362 (0.1512)
Visit 4b, 5 min Post-CAC	1.287 (0.1507)	1.688 (0.1519)	2.638 (0.1155)	2.712 (0.1427)
Visit 4b, 7 min Post-CAC	1.181 (0.1462)	1.656 (0.1532)	2.644 (0.1249)	2.755 (0.1390)
Visit 5, 3 min Post-CAC	0.495 (0.0918)	0.594 (0.1296)	1.915 (0.1307)	2.070 (0.1319)
Visit 5, 5 min Post-CAC	0.601 (0.0930)	0.791 (0.1350)	1.973 (0.1255)	2.345 (0.1378)
Visit 5, 7 min Post-CAC	0.618 (0.1083)	0.972 (0.1548)	1.920 (0.1394)	2.358 (0.1221)

Primary outcome: Conjunctival Redness

Measure	Combination n = 47	Ketotifen Fumarate n = 48	Brimonidine Tartrate n = 47	Vehicle n = 46
Visit 4b, 7 min Post-CAC	1.372 (0.1088)	1.844 (0.0895)	1.883 (0.1083)	2.155 (0.0850)
Visit 4b, 15 min Post-CAC	1.617 (0.1204)	2.130 (0.0939)	2.069 (0.1189)	2.321 (0.0934)
Visit 4b, 20 min Post-CAC	1.649 (0.1165)	2.146 (0.0953)	1.984 (0.1296)	2.315 (0.0961)
Visit 5, 7 min Post-CAC	0.591 (0.0846)	1.393 (0.0944)	1.005 (0.1300)	2.052 (0.1143)
Visit 5, 15 min Post-CAC	0.765 (0.1043)	1.662 (0.1036)	1.069 (0.1338)	2.268 (0.1111)
Visit 5, 20 min Post-CAC	0.735 (0.1012)	1.727 (0.1088)	1.021 (0.1343)	2.238 (0.1182)

Adverse events

Time frame: Assessed through the study, approximately 10 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Combination	0 of 47 (0%)	3 of 47 (6.4%)	0 of 47
Ketotifen Fumarate	0 of 48 (0%)	6 of 48 (12.5%)	0 of 48
Brimonidine Tartrate	0 of 47 (0%)	6 of 47 (12.8%)	0 of 47
Vehicle	0 of 46 (0%)	4 of 46 (8.7%)	0 of 46

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Allergic Conjunctivitis

RecruitingPhase 3
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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.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 11 inclusion and 28 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 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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 14 Feb 2025). 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: Assessed at Visit 4b on day 1 (duration of action CAC at 8 hours post-instillation of study medication) and Visit 5 on day 15 (onset of action CAC at 15 minutes post-instillation of study medication).). 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 NCT05579730.

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 14 Feb 2025.