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Seasonal Allergic ConjunctivitisPhase 3NCT05591755

Evaluation of Brimonidine Tartrate/Ketotifen Fumarate Combination in Adults With Seasonal Allergic Conjunctivitis

A Phase 3 study testing Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution, Ketotifen fumarate ophthalmic solution 0.035% and Brimonidine tartrate ophthalmic solution 0.025% in people with Seasonal Allergic Conjunctivitis, run by Bausch & Lomb Incorporated at 6 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 compared to its individual components and compared to vehicle in a population of subjects with seasonal allergic conjunctivitis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Seasonal Allergic Conjunctivitis
What is being tested?
Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution, Ketotifen fumarate ophthalmic solution 0.035% and Brimonidine tartrate ophthalmic solution 0.025%
Could I receive a placebo?
No, everyone receives an active treatment
How many people
229 participants
Where
6 sitesUnited States
Study dates
18 Nov 2022to 9 Aug 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must:
  • be at least 18 years of age of either sex and any race;
  • provide written informed consent and sign the Health Information Portability and Accountability Act (HIPAA) form;
  • be willing and able to follow all instructions and attend all study visits;
  • provide proof of COVID-19 vaccination
  • be able and willing to discontinue wearing contact lenses for at least 72 hours prior to Visit 2 and for the duration of the visit;
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  • have seasonal allergic conjunctivitis to ragweed or timothy grass documented by a self-reported history of ocular allergic symptoms for the last 2 consecutive years during the ragweed or timothy grass seasons and a positive skin test reaction to ragweed or timothy grass pollen as confirmed by the allergic skin test given at or within 24 months of the subject's Visit 1;
  • (If female and of childbearing potential) agree to have urine pregnancy testing performed at visit 2, (must be negative); 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 and 1 month after receiving investigational drug. 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 receiving investigational drug (Visit 2). 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· 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 receiving investigational drug (Visit 2). Without a vasectomy, must use condoms with spermicidal foam/gel/film/cream/suppository throughout the study duration, for at least 14 days prior to and 1 month after investigational drug (Visit 2).
  • have a calculated visual acuity (VA) of 0.7 logMAR or better in each eye as measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart at Visit 1;
  • have a positive Allergen BioCube challenge response to pollen exposure at the 90 minute time point of ABC exposure at Visit 2, defined as bilateral score of >2 in ocular itching and ocular redness.

Who cannot join

  • Subjects may not:
  • have known contraindications or sensitivities to the use of any of the investigational product medication or components;
  • have a history of mild persistent, moderate or severe asthma within the preceding 5 years according to the National Heart, Blood, and Lung Institute classification (with the exception of exercise induced asthma).
  • Note: Subjects with fall induced asthma that is either mild persistent (defined as >1 per week, but <1 per day), moderate persistent, or severe persistent will be excluded.
  • have an upper respiratory tract or sinus infection within the previous 2 weeks of Visit 1;
  • have a history of anaphylaxis or poor tolerability of previously administered allergen;
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  • have a compromised lung function at Visit 1 (defined as a peak expiratory flow rate [PEFR] that is below 80% of the predicted average PEFR, as calculated by gender, age, and measured height from the Mini-Wright instruction's table: Normal Adult Predicted Average Peak Expiratory Flow).
  • have an abnormal blood pressure (defined as ≤ 90 or ≥ 160 (systolic) measured in mmHg or ≤ 60 or ≥ 100 (diastolic) measured in mmHg) at Visit 1;
  • 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 three months prior to Visit 1, or during the trial or a history of refractive surgery six months prior to Visit 1, or have systemic surgery planned during the clinical trial or within 30 days after;

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • 101 Andover Eye Associates

    Andover, Massachusetts, 01810

  • 108 Emerson Clinical Research Institute Inc.

    Falls Church, Virginia, 22046

  • 105 - Advancing Vision Research

    Goodlettsville, Tennessee, 37072

  • 104 Butchertown Clinical Trials

    Louisville, Kentucky, 40206

  • 102 Total Eye Care, PA

    Memphis, Tennessee, 38119

  • 107 Virginia Eye Institute

    Richmond, Virginia, 23230

Other trials in United States

About this study

Official title: Evaluation of the Combination Drug Product Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Ophthalmic Solution Compared to Its Components and Vehicle in an Allergen BioCube® in Subjects With Seasonal Allergic Conjunctivitis

To evaluate the efficacy of Combo compared to its individual components and compared to vehicle in a population of subjects with seasonal allergic conjunctivitis.

Being tested
Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution, Ketotifen fumarate ophthalmic solution 0.035%, Brimonidine tartrate ophthalmic solution 0.025%, Experimental: Vehicle ophthalmic solution

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% Ophthalmic SolutionDrug

    Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution

  • Ketotifen fumarate ophthalmic solution 0.035%Drug

    Ketotifen fumarate ophthalmic solution 0.035%

  • Brimonidine tartrate ophthalmic solution 0.025%Drug

    Brimonidine tartrate ophthalmic solution 0.025%

  • Experimental: Vehicle ophthalmic solutionDrug

    Experimental: Vehicle ophthalmic solution

Study groups in NCT05591755
Study groupRoleWhat they receive
Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic SolutionExperimentalBrimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution
Receives: Drug: Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution
Ketotifen fumarate ophthalmic solution 0.035%ExperimentalKetotifen fumarate ophthalmic solution 0.035%
Receives: Drug: Ketotifen fumarate ophthalmic solution 0.035%
Brimonidine tartrate ophthalmic solution 0.025%ExperimentalBrimonidine tartrate ophthalmic solution 0.025%
Receives: Drug: Brimonidine tartrate ophthalmic solution 0.025%
Vehicle ophthalmic solutionExperimentalVehicle ophthalmic solution
Receives: Drug: Experimental: Vehicle ophthalmic solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ocular Itching Symptom Score

    Ocular itching score evaluated by the subject at 10(±1), 30(±1), 60(±5), 360(±5), 420(±5), and 480(±5) minutes post-instillation of assigned IP at Visit 2 (0-4 scale, allowing half unit increments), with 4 is the worse outcome.

    Measured: Assessed up to 480 minutes post-instillation of assigned IP

  2. Ocular Redness Measured by Ocular Itching Scale

    Ocular redness evaluated by the Investigator using slit lamp at 10(±1), 30(±1), 60(±5), 360(±5), 420(±5), and 480(±5) minutes post-instillation of assigned IP at Visit 2 (0-4 scale, allowing half unit increments), with 4 being the worse outcome.

    Measured: Assessed up to 480 minutes post-instillation of assigned IP

Secondary outcomes (3)

  1. Tearing Measured by Watery Eyes Scale

    Tearing evaluated by the subject at 10(±1), 30(±1), 60(±5), 360(±5), 420(±5), and 480(±5) minutes post-instillation of assigned IP at Visit 2 (0-4 scale, NOT allowing half unit increments), with 4 being the worse outcome.

    Measured: up to 480 minutes post-instillation of assigned IP

  2. Lid Swelling Measured by Eyelid Swelling Scale

    Lid swelling evaluated by the subject at 10(±1), 30(±1), 60(±5), 360(±5), 420(±5), and 480(±5) minutes post-instillation of assigned IP at Visit 2 (0-3 scale, NOT allowing half unit increments), with 3 being the worst outcome

    Measured: up to 480 minutes post-instillation of assigned IP

  3. Chemosis Evaluated

    Chemosis evaluated by the Investigator using slit lamp at 10(±1), 30(±1), 60(±5), 360(±5), 420(±5), and 480(±5) minutes post-instillation of assigned IP at Visit 2 (0-4 scale, allowing half unit increments), with 4 being the worse outcome.

    Measured: up to 480 minutes post-instillation of assigned IP

Timeline

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

  1. First posted24 Oct 2022
  2. Study start18 Nov 2022
  3. Primary completion9 Aug 2023
  4. Study completion9 Aug 2023

Resources

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
229 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05591755
Sponsor's protocol ID
910
Status last verified
Jun 2025
First submitted
6 Oct 2022
Last updated
1 Jul 2025
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution, Ketotifen fumarate ophthalmic solution 0.035% and Brimonidine tartrate ophthalmic solution 0.025% in people with Seasonal Allergic Conjunctivitis, run by Bausch & Lomb Incorporated at 6 sites 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 11 inclusion and 10 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 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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. 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 1 Jul 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 Symptom Score (time frame: Assessed up to 480 minutes post-instillation of assigned IP). 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 NCT05591755.

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 1 Jul 2025.

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Clinical Trial NCT05591755 | AzTrials