Trial Outcomes & Findings for Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Acute Allergic Conjunctivitis. (NCT NCT00770133)
NCT ID: NCT00770133
Last Updated: 2020-10-27
Results Overview
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
COMPLETED
PHASE3
141 participants
3, 5, and 7 minutes post challenge at 14 days
2020-10-27
Participant Flow
There were 70 eyes in the KetoNaph group, 72 in the ketotifen group, 70 in the naphazoline group, and 70 in the vehicle group, for a total of 282 eyes (141 subjects).
Participant milestones
| Measure |
Ketotifen/Naphazoline
Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
Ketotifen/naphazoline: One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.
|
Ketotifen
Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
Ketotifen: One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.
|
Naphazoline
Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
Naphazoline: One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.
|
Vehicle
Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
Vehicle: One drop of vehicle ophthalmic solution at visit 3 and visit 4.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
35
|
36
|
35
|
35
|
|
Overall Study
COMPLETED
|
32
|
35
|
32
|
32
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Acute Allergic Conjunctivitis.
Baseline characteristics by cohort
| Measure |
Ketotifen/Naphazoline
n=35 Participants
Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
Ketotifen/naphazoline: One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.
|
Ketotifen
n=36 Participants
Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
Ketotifen: One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.
|
Naphazoline
n=35 Participants
Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
Naphazoline: One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.
|
Vehicle
n=35 Participants
Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
Vehicle: One drop of vehicle ophthalmic solution at visit 3 and visit 4.
|
Total
n=141 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
36.1 years
n=5 Participants
|
40.7 years
n=7 Participants
|
38.2 years
n=5 Participants
|
38.4 years
n=4 Participants
|
38.4 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
73 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
68 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 3, 5, and 7 minutes post challenge at 14 daysPopulation: The intent to treat population consisted of participants who were randomized, received investigational treatment, and had at least 1 post-challeng assessment.
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
Outcome measures
| Measure |
Ketotifen/Naphazoline
n=68 eyes
Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
Ketotifen/naphazoline: One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.
|
Ketotifen
n=72 eyes
Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
Ketotifen: One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.
|
Naphazoline
n=68 eyes
Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
Naphazoline: One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.
|
Vehicle
n=70 eyes
Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
Vehicle: One drop of vehicle ophthalmic solution at visit 3 and visit 4.
|
|---|---|---|---|---|
|
Ocular Itching
3 minutes post-challenge
|
0.43 score on a scale
Standard Deviation 0.62
|
0.40 score on a scale
Standard Deviation 0.65
|
1.60 score on a scale
Standard Deviation 0.92
|
1.81 score on a scale
Standard Deviation 0.88
|
|
Ocular Itching
5 minutes post-challenge
|
0.65 score on a scale
Standard Deviation 0.76
|
0.59 score on a scale
Standard Deviation 0.79
|
1.67 score on a scale
Standard Deviation 1.01
|
1.96 score on a scale
Standard Deviation 0.94
|
|
Ocular Itching
7 minutes post-challenge
|
0.60 score on a scale
Standard Deviation 0.83
|
0.56 score on a scale
Standard Deviation 0.87
|
1.54 score on a scale
Standard Deviation 0.96
|
1.84 score on a scale
Standard Deviation 1.01
|
PRIMARY outcome
Timeframe: 7, 15, and 20 minutes post challenge at 14 daysPopulation: The intent to treat population consisted of participants who were randomized, received investigational treatment, and had at least 1 post-challeng assessment.
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.
Outcome measures
| Measure |
Ketotifen/Naphazoline
n=68 eyes
Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
Ketotifen/naphazoline: One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.
|
Ketotifen
n=72 eyes
Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
Ketotifen: One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.
|
Naphazoline
n=68 eyes
Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
Naphazoline: One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.
|
Vehicle
n=70 eyes
Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
Vehicle: One drop of vehicle ophthalmic solution at visit 3 and visit 4.
|
|---|---|---|---|---|
|
Conjunctival Redness
20 minutes post-challenge
|
1.13 score on a scale
Standard Deviation 1.02
|
1.88 score on a scale
Standard Deviation 0.89
|
1.57 score on a scale
Standard Deviation 0.92
|
2.18 score on a scale
Standard Deviation 0.85
|
|
Conjunctival Redness
7 minutes post-challeng
|
0.89 score on a scale
Standard Deviation 0.87
|
1.49 score on a scale
Standard Deviation 0.83
|
1.63 score on a scale
Standard Deviation 0.84
|
2.06 score on a scale
Standard Deviation 0.77
|
|
Conjunctival Redness
15 minutes post-challenge
|
1.13 score on a scale
Standard Deviation 1.00
|
1.80 score on a scale
Standard Deviation 0.87
|
1.69 score on a scale
Standard Deviation 0.89
|
2.26 score on a scale
Standard Deviation 0.78
|
SECONDARY outcome
Timeframe: 7, 15, and 20 minutes post challenge at 14 daysPopulation: This outcome measure was not assessed for the Vehicle group. The intent to treat population consisted of participants who were randomized, received investigational treatment, and had at least 1 post-challenge assessment.
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.
Outcome measures
| Measure |
Ketotifen/Naphazoline
n=68 eyes
Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
Ketotifen/naphazoline: One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.
|
Ketotifen
n=72 eyes
Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
Ketotifen: One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.
|
Naphazoline
n=68 eyes
Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
Naphazoline: One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.
|
Vehicle
Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
Vehicle: One drop of vehicle ophthalmic solution at visit 3 and visit 4.
|
|---|---|---|---|---|
|
Ciliary Redness
20 minutes post-challenge
|
1.04 score on a scale
Standard Deviation 1.03
|
1.76 score on a scale
Standard Deviation 0.94
|
1.54 score on a scale
Standard Deviation 0.92
|
—
|
|
Ciliary Redness
7 minutes post-challenge
|
0.81 score on a scale
Standard Deviation 0.86
|
1.33 score on a scale
Standard Deviation 0.88
|
1.49 score on a scale
Standard Deviation 0.89
|
—
|
|
Ciliary Redness
15 minutes post-challenge
|
1.05 score on a scale
Standard Deviation 1.05
|
1.76 score on a scale
Standard Deviation 0.91
|
1.59 score on a scale
Standard Deviation 0.91
|
—
|
SECONDARY outcome
Timeframe: 7, 15, and 20 minutes post challenge at 14 daysPopulation: This outcome measure was not assessed for the Vehicle group. The intent to treat population consisted of participants who were randomized, received investigational treatment, and had at least 1 post-challenge assessment.
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.
Outcome measures
| Measure |
Ketotifen/Naphazoline
n=68 eyes
Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
Ketotifen/naphazoline: One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.
|
Ketotifen
n=72 eyes
Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
Ketotifen: One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.
|
Naphazoline
n=68 eyes
Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
Naphazoline: One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.
|
Vehicle
Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
Vehicle: One drop of vehicle ophthalmic solution at visit 3 and visit 4.
|
|---|---|---|---|---|
|
Episcleral Redness
15 minutes post-challenge
|
1.17 score on a scale
Standard Deviation 1.01
|
1.76 score on a scale
Standard Deviation 0.88
|
1.68 score on a scale
Standard Deviation 0.94
|
—
|
|
Episcleral Redness
7 minutes post-challenge
|
0.91 score on a scale
Standard Deviation 0.89
|
1.51 score on a scale
Standard Deviation 0.85
|
1.65 score on a scale
Standard Deviation 0.86
|
—
|
|
Episcleral Redness
20 minutes post-challenge
|
1.15 score on a scale
Standard Deviation 1.03
|
1.88 score on a scale
Standard Deviation 0.90
|
1.60 score on a scale
Standard Deviation 0.94
|
—
|
SECONDARY outcome
Timeframe: 7, 15, and 20 minutes post challenge at 14 daysPopulation: This outcome measure was not assessed for the Vehicle group. The intent to treat population consisted of participants who were randomized, received investigational treatment, and had at least 1 post-challenge assessment.
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.
Outcome measures
| Measure |
Ketotifen/Naphazoline
n=68 eyes
Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
Ketotifen/naphazoline: One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.
|
Ketotifen
n=72 eyes
Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
Ketotifen: One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.
|
Naphazoline
n=68 eyes
Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
Naphazoline: One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.
|
Vehicle
Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
Vehicle: One drop of vehicle ophthalmic solution at visit 3 and visit 4.
|
|---|---|---|---|---|
|
Chemosis
7 minutes post-challenge
|
0.27 score on a scale
Standard Deviation 0.33
|
0.28 score on a scale
Standard Deviation 0.30
|
0.39 score on a scale
Standard Deviation 0.40
|
—
|
|
Chemosis
15 minutes post-challenge
|
0.34 score on a scale
Standard Deviation 0.38
|
0.46 score on a scale
Standard Deviation 0.47
|
0.54 score on a scale
Standard Deviation 0.55
|
—
|
|
Chemosis
20 minutes post-challenge
|
0.39 score on a scale
Standard Deviation 0.41
|
0.49 score on a scale
Standard Deviation 0.46
|
0.54 score on a scale
Standard Deviation 0.58
|
—
|
SECONDARY outcome
Timeframe: 7, 15, and 20 minutes post challenge at 14 daysPopulation: This outcome measure was not assessed for the Vehicle group. The intent to treat population consisted of participants who were randomized, received investigational treatment, and had at least 1 post-challenge assessment.
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.
Outcome measures
| Measure |
Ketotifen/Naphazoline
n=68 eyes
Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
Ketotifen/naphazoline: One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.
|
Ketotifen
n=72 eyes
Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
Ketotifen: One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.
|
Naphazoline
n=68 eyes
Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
Naphazoline: One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.
|
Vehicle
Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
Vehicle: One drop of vehicle ophthalmic solution at visit 3 and visit 4.
|
|---|---|---|---|---|
|
Eyelid Swelling
15 minutes post-challenge
|
0.2 score on a scale
Standard Error 0.5
|
0.2 score on a scale
Standard Error 0.4
|
0.2 score on a scale
Standard Error 0.4
|
—
|
|
Eyelid Swelling
7 minutes post-challenge
|
0.2 score on a scale
Standard Error 0.4
|
0.2 score on a scale
Standard Error 0.4
|
0.2 score on a scale
Standard Error 0.4
|
—
|
|
Eyelid Swelling
20 minutes post-challenge
|
0.2 score on a scale
Standard Error 0.5
|
0.2 score on a scale
Standard Error 0.4
|
0.2 score on a scale
Standard Error 0.4
|
—
|
SECONDARY outcome
Timeframe: 7, 15, and 20 minutes post challenge at 14 daysPopulation: This outcome measure was not assessed for the Vehicle group. The intent to treat population consisted of participants who were randomized, received investigational treatment, and had at least 1 post-challenge assessment.
Tearing was evaluated by the participant at 7, 15, and 20 minutes post challenge. Tearing was recorded as either absent or present.
Outcome measures
| Measure |
Ketotifen/Naphazoline
n=68 eyes
Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
Ketotifen/naphazoline: One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.
|
Ketotifen
n=72 eyes
Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
Ketotifen: One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.
|
Naphazoline
n=68 eyes
Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
Naphazoline: One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.
|
Vehicle
Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
Vehicle: One drop of vehicle ophthalmic solution at visit 3 and visit 4.
|
|---|---|---|---|---|
|
Percentage of Eyes With hTearing
7 minutes post-challenge
|
7 eyes
|
11 eyes
|
13 eyes
|
—
|
|
Percentage of Eyes With hTearing
15 minutes post-challenge
|
4 eyes
|
9 eyes
|
12 eyes
|
—
|
|
Percentage of Eyes With hTearing
20 minutes post-challenge
|
5 eyes
|
6 eyes
|
11 eyes
|
—
|
SECONDARY outcome
Timeframe: 7, 15, and 20 minutes post challenge at 14 daysPopulation: This outcome measure was not assessed for the Vehicle group. The intent to treat population consisted of participants who were randomized, received investigational treatment, and had at least 1 post-challenge assessment.
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.
Outcome measures
| Measure |
Ketotifen/Naphazoline
n=68 eyes
Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
Ketotifen/naphazoline: One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.
|
Ketotifen
n=72 eyes
Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
Ketotifen: One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.
|
Naphazoline
n=68 eyes
Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
Naphazoline: One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.
|
Vehicle
Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
Vehicle: One drop of vehicle ophthalmic solution at visit 3 and visit 4.
|
|---|---|---|---|---|
|
Percentage of Eyes With Ocular Mucus Discharge
7 minutes post-challenge
|
0 eyes
|
0 eyes
|
0 eyes
|
—
|
|
Percentage of Eyes With Ocular Mucus Discharge
15 minutes post-challenge
|
0 eyes
|
0 eyes
|
0 eyes
|
—
|
|
Percentage of Eyes With Ocular Mucus Discharge
20 minutes post-challenge
|
0 eyes
|
0 eyes
|
0 eyes
|
—
|
Adverse Events
Ketotifen/Naphazoline
Ketotifen
Naphazoline
Vehicle
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Contact sponsor directly for details.
- Publication restrictions are in place
Restriction type: OTHER