Allergic Conjunctivitis
Conditions
Brief 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.
Interventions
One drop of ketotifen/naphazoline in study eye at visit 3 and visit 4.
DRUGKetotifen
One drop of Ketotifen in study eye at visit 3 and visit 4.
DRUGNaphazoline
One drop of naphazoline in study eye at vist 3 and visit 4.
DRUGVehicle
One drop of vehicle in study eye at visit 3 and visit 4.
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Itching | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chemosis | 7, 15, and 20 minutes post challenge at 14 days | 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. |
| Eyelid Swelling | 7, 15, and 20 minutes post challenge at 14 days | 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. |
| Ciliary Redness | 7, 15, and 20 minutes post challenge at 14 days | 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. |
| Percentage of Eyes With Ocular Mucus Drainage | 7, 15, and 20 minutes post challenge at 14 days | 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. |
| Percentage of Eyes With Tearing | 7, 15, and 20 minutes post challenge at 14 days | 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. |
| Episcleral Redness | 7, 15, and 20 minutes post challenge at 14 days | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| KetoNaph KetoNaph (ketotifen fumarate 0.025%, naphazoline HCl 0.05%) ophthalmic solution Ketotifen/naphazoline: One drop of ketotifen/naphazoline in study eye at visit 3 and visit 4. | 36 |
| Ketotifen Ketotifen fumarate 0.025% ophthalmic solution Ketotifen: One drop of Ketotifen in study eye at visit 3 and visit 4. | 36 |
| Naphazoline Naphazoline HCl 0.05% ophthalmic solution Naphazoline: One drop of naphazoline in study eye at vist 3 and visit 4. | 35 |
| Vehicle Vehicle of KetoNaph ophthalmic solution Vehicle: One drop of vehicle in study eye at visit 3 and visit 4. | 37 |
| Total | 144 |
Baseline characteristics
| Characteristic | KetoNaph | Ketotifen | Naphazoline | Vehicle | Total |
|---|---|---|---|---|---|
| Age, Continuous | 33.63 years | 34.15 years | 35.56 years | 33.09 years | 34.10 years |
| Sex: Female, Male Female | 20 Participants | 18 Participants | 18 Participants | 21 Participants | 77 Participants |
| Sex: Female, Male Male | 16 Participants | 18 Participants | 17 Participants | 16 Participants | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 36 | 0 / 36 | 0 / 35 | 0 / 37 |
| serious Total, serious adverse events | 0 / 36 | 0 / 36 | 0 / 35 | 0 / 37 |
Outcome results
Primary
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.
Time frame: 7, 15, and 20 minutes post challenge at 14 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KetoNaph | Conjunctival Hyperemia | 15 minutes post-challenge | 1.39 units on a scale | Standard Deviation 0.865 |
| KetoNaph | Conjunctival Hyperemia | 20 minutes post-challenge | 1.26 units on a scale | Standard Deviation 0.818 |
| KetoNaph | Conjunctival Hyperemia | 7 minutes post-challenge | 1.13 units on a scale | Standard Deviation 0.872 |
| Ketotifen | Conjunctival Hyperemia | 15 minutes post-challenge | 1.89 units on a scale | Standard Deviation 0.712 |
| Ketotifen | Conjunctival Hyperemia | 20 minutes post-challenge | 1.77 units on a scale | Standard Deviation 0.805 |
| Ketotifen | Conjunctival Hyperemia | 7 minutes post-challenge | 1.49 units on a scale | Standard Deviation 0.761 |
| Naphazoline | Conjunctival Hyperemia | 7 minutes post-challenge | 1.62 units on a scale | Standard Deviation 0.86 |
| Naphazoline | Conjunctival Hyperemia | 15 minutes post-challenge | 1.68 units on a scale | Standard Deviation 0.957 |
| Naphazoline | Conjunctival Hyperemia | 20 minutes post-challenge | 1.53 units on a scale | Standard Deviation 0.959 |
| Vehicle | Conjunctival Hyperemia | 15 minutes post-challenge | 2.33 units on a scale | Standard Deviation 0.551 |
| Vehicle | Conjunctival Hyperemia | 20 minutes post-challenge | 2.24 units on a scale | Standard Deviation 0.587 |
| Vehicle | Conjunctival Hyperemia | 7 minutes post-challenge | 2.24 units on a scale | Standard Deviation 0.581 |
Primary
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.
Time frame: 3, 5, and 7 minutes post challenge at 14 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KetoNaph | Ocular Itching | 3 minutes post-challenge | 0.50 score on a scale | Standard Deviation 0.835 |
| KetoNaph | Ocular Itching | 7 minutes post-challenge | 0.56 score on a scale | Standard Deviation 0.856 |
| KetoNaph | Ocular Itching | 5 minutes post-challenge | 0.56 score on a scale | Standard Deviation 0.785 |
| Ketotifen | Ocular Itching | 3 minutes post-challenge | 0.49 score on a scale | Standard Deviation 0.86 |
| Ketotifen | Ocular Itching | 7 minutes post-challenge | 0.72 score on a scale | Standard Deviation 0.885 |
| Ketotifen | Ocular Itching | 5 minutes post-challenge | 0.69 score on a scale | Standard Deviation 0.923 |
| Naphazoline | Ocular Itching | 5 minutes post-challenge | 1.90 score on a scale | Standard Deviation 0.936 |
| Naphazoline | Ocular Itching | 3 minutes post-challenge | 1.87 score on a scale | Standard Deviation 0.932 |
| Naphazoline | Ocular Itching | 7 minutes post-challenge | 1.75 score on a scale | Standard Deviation 0.971 |
| Vehicle | Ocular Itching | 3 minutes post-challenge | 1.93 score on a scale | Standard Deviation 0.998 |
| Vehicle | Ocular Itching | 7 minutes post-challenge | 1.97 score on a scale | Standard Deviation 0.984 |
| Vehicle | Ocular Itching | 5 minutes post-challenge | 2.17 score on a scale | Standard Deviation 0.885 |
Secondary
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.
Time frame: 7, 15, and 20 minutes post challenge at 14 days
Population: This outcome measure was not assessed for the Vehicle group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KetoNaph | Chemosis | 7 minutes post-challenge | 0.22 score on a scale | Standard Deviation 0.41 |
| KetoNaph | Chemosis | 20 minutes post-challenge | 0.34 score on a scale | Standard Deviation 0.549 |
| KetoNaph | Chemosis | 15 minutes post-challenge | 0.29 score on a scale | Standard Deviation 0.488 |
| Ketotifen | Chemosis | 15 minutes post-challenge | 0.42 score on a scale | Standard Deviation 0.42 |
| Ketotifen | Chemosis | 7 minutes post-challenge | 0.22 score on a scale | Standard Deviation 0.313 |
| Ketotifen | Chemosis | 20 minutes post-challenge | 0.41 score on a scale | Standard Deviation 0.45 |
| Naphazoline | Chemosis | 7 minutes post-challenge | 0.51 score on a scale | Standard Deviation 0.705 |
| Naphazoline | Chemosis | 20 minutes post-challenge | 0.66 score on a scale | Standard Deviation 0.869 |
| Naphazoline | Chemosis | 15 minutes post-challenge | 0.66 score on a scale | Standard Deviation 0.787 |
Secondary
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.
Time frame: 7, 15, and 20 minutes post challenge at 14 days
Population: This outcome measure was not assessed for the Vehicle group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KetoNaph | Ciliary Redness | 15 minutes post-challenge | 1.28 units on a scale | Standard Deviation 0.907 |
| KetoNaph | Ciliary Redness | 7 minutes post-challenge | 1.05 units on a scale | Standard Deviation 0.873 |
| KetoNaph | Ciliary Redness | 20 minutes post-challenge | 1.15 units on a scale | Standard Deviation 0.854 |
| Ketotifen | Ciliary Redness | 15 minutes post-challenge | 1.79 units on a scale | Standard Deviation 0.791 |
| Ketotifen | Ciliary Redness | 7 minutes post-challenge | 1.39 units on a scale | Standard Deviation 0.774 |
| Ketotifen | Ciliary Redness | 20 minutes post-challenge | 1.77 units on a scale | Standard Deviation 0.81 |
| Naphazoline | Ciliary Redness | 7 minutes post-challenge | 1.66 units on a scale | Standard Deviation 0.917 |
| Naphazoline | Ciliary Redness | 20 minutes post-challenge | 1.58 units on a scale | Standard Deviation 1.032 |
| Naphazoline | Ciliary Redness | 15 minutes post-challenge | 1.71 units on a scale | Standard Deviation 0.995 |
Secondary
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.
Time frame: 7, 15, and 20 minutes post challenge at 14 days
Population: This outcome measure was not assessed for the Vehicle group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KetoNaph | Episcleral Redness | 15 minutes post-challenge | 1.41 score on a scale | Standard Deviation 0.865 |
| KetoNaph | Episcleral Redness | 7 minutes post-challenge | 1.21 score on a scale | Standard Deviation 0.891 |
| KetoNaph | Episcleral Redness | 20 minutes post-challenge | 1.35 score on a scale | Standard Deviation 0.895 |
| Ketotifen | Episcleral Redness | 15 minutes post-challenge | 1.87 score on a scale | Standard Deviation 0.732 |
| Ketotifen | Episcleral Redness | 7 minutes post-challenge | 1.52 score on a scale | Standard Deviation 0.749 |
| Ketotifen | Episcleral Redness | 20 minutes post-challenge | 1.88 score on a scale | Standard Deviation 0.777 |
| Naphazoline | Episcleral Redness | 7 minutes post-challenge | 1.71 score on a scale | Standard Deviation 0.951 |
| Naphazoline | Episcleral Redness | 20 minutes post-challenge | 1.68 score on a scale | Standard Deviation 1.026 |
| Naphazoline | Episcleral Redness | 15 minutes post-challenge | 1.77 score on a scale | Standard Deviation 0.988 |
Secondary
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.
Time frame: 7, 15, and 20 minutes post challenge at 14 days
Population: This outcome measure was not assessed for the Vehicle group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KetoNaph | Eyelid Swelling | 7 minutes post-challenge | 0.13 score on a scale | Standard Deviation 0.373 |
| KetoNaph | Eyelid Swelling | 20 minutes post-challenge | 0.26 score on a scale | Standard Deviation 0.581 |
| KetoNaph | Eyelid Swelling | 15 minutes post-challenge | 0.25 score on a scale | Standard Deviation 0.55 |
| Ketotifen | Eyelid Swelling | 15 minutes post-challenge | 0.37 score on a scale | Standard Deviation 0.638 |
| Ketotifen | Eyelid Swelling | 20 minutes post-challenge | 0.39 score on a scale | Standard Deviation 0.686 |
| Ketotifen | Eyelid Swelling | 7 minutes post-challenge | 0.32 score on a scale | Standard Deviation 0.604 |
| Naphazoline | Eyelid Swelling | 20 minutes post-challenge | 0.59 score on a scale | Standard Deviation 0.729 |
| Naphazoline | Eyelid Swelling | 7 minutes post-challenge | 0.61 score on a scale | Standard Deviation 0.783 |
| Naphazoline | Eyelid Swelling | 15 minutes post-challenge | 0.61 score on a scale | Standard Deviation 0.746 |
Secondary
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.
Time frame: 7, 15, and 20 minutes post challenge at 14 days
Population: This outcome measure was not assessed for the Vehicle group.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| KetoNaph | Percentage of Eyes With Ocular Mucus Drainage | 15 minutes post-challenge | 11 eyes |
| KetoNaph | Percentage of Eyes With Ocular Mucus Drainage | 7 minutes post-challenge | 7 eyes |
| KetoNaph | Percentage of Eyes With Ocular Mucus Drainage | 20 minutes post-challenge | 10 eyes |
| Ketotifen | Percentage of Eyes With Ocular Mucus Drainage | 15 minutes post-challenge | 19 eyes |
| Ketotifen | Percentage of Eyes With Ocular Mucus Drainage | 7 minutes post-challenge | 12 eyes |
| Ketotifen | Percentage of Eyes With Ocular Mucus Drainage | 20 minutes post-challenge | 16 eyes |
| Naphazoline | Percentage of Eyes With Ocular Mucus Drainage | 7 minutes post-challenge | 13 eyes |
| Naphazoline | Percentage of Eyes With Ocular Mucus Drainage | 20 minutes post-challenge | 18 eyes |
| Naphazoline | Percentage of Eyes With Ocular Mucus Drainage | 15 minutes post-challenge | 18 eyes |
Secondary
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.
Time frame: 7, 15, and 20 minutes post challenge at 14 days
Population: This outcome measure was not assessed for the Vehicle group.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| KetoNaph | Percentage of Eyes With Tearing | 15 minutes post-challenge | 6 eyes |
| KetoNaph | Percentage of Eyes With Tearing | 7 minutes post-challenge | 3 eyes |
| KetoNaph | Percentage of Eyes With Tearing | 20 minutes post-challenge | 5 eyes |
| Ketotifen | Percentage of Eyes With Tearing | 15 minutes post-challenge | 7 eyes |
| Ketotifen | Percentage of Eyes With Tearing | 7 minutes post-challenge | 11 eyes |
| Ketotifen | Percentage of Eyes With Tearing | 20 minutes post-challenge | 7 eyes |
| Naphazoline | Percentage of Eyes With Tearing | 7 minutes post-challenge | 23 eyes |
| Naphazoline | Percentage of Eyes With Tearing | 20 minutes post-challenge | 13 eyes |
| Naphazoline | Percentage of Eyes With Tearing | 15 minutes post-challenge | 16 eyes |