Trial Outcomes & Findings for Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Allergic Conjunctivitis. (NCT NCT00769886)
NCT ID: NCT00769886
Last Updated: 2024-04-03
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
144 participants
Primary outcome timeframe
3, 5, and 7 minutes post challenge at 14 days
Results posted on
2024-04-03
Participant Flow
Unit of analysis: Eyes
Participant milestones
| Measure |
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.
|
Ketotifen
Ketotifen fumarate 0.025% ophthalmic solution
Ketotifen: One drop of Ketotifen in study eye at visit 3 and visit 4.
|
Naphazoline
Naphazoline HCl 0.05% ophthalmic solution
Naphazoline: One drop of naphazoline in study eye at vist 3 and visit 4.
|
Vehicle
Vehicle of KetoNaph ophthalmic solution
Vehicle: One drop of vehicle in study eye at visit 3 and visit 4.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
36 72
|
36 72
|
35 70
|
37 74
|
|
Overall Study
COMPLETED
|
31 62
|
32 64
|
34 68
|
35 70
|
|
Overall Study
NOT COMPLETED
|
5 10
|
4 8
|
1 2
|
2 4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Allergic Conjunctivitis.
Baseline characteristics by cohort
| Measure |
KetoNaph
n=36 Participants
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.
|
Ketotifen
n=36 Participants
Ketotifen fumarate 0.025% ophthalmic solution Ketotifen: One drop of Ketotifen in study eye at visit 3 and visit 4.
|
Naphazoline
n=35 Participants
Naphazoline HCl 0.05% ophthalmic solution Naphazoline: One drop of naphazoline in study eye at vist 3 and visit 4.
|
Vehicle
n=37 Participants
Vehicle of KetoNaph ophthalmic solution Vehicle: One drop of vehicle in study eye at visit 3 and visit 4.
|
Total
n=144 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
33.63 years
n=99 Participants
|
34.15 years
n=107 Participants
|
35.56 years
n=206 Participants
|
33.09 years
n=7 Participants
|
34.10 years
n=31 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
21 Participants
n=7 Participants
|
77 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
67 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 3, 5, and 7 minutes post challenge at 14 daysOcular 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 |
KetoNaph
n=72 eyes
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.
|
Ketotifen
n=71 eyes
Ketotifen fumarate 0.025% ophthalmic solution
Ketotifen: One drop of Ketotifen in study eye at visit 3 and visit 4.
|
Naphazoline
n=70 eyes
Naphazoline HCl 0.05% ophthalmic solution
Naphazoline: One drop of naphazoline in study eye at vist 3 and visit 4.
|
Vehicle
n=74 eyes
Vehicle of KetoNaph ophthalmic solution
Vehicle: One drop of vehicle in study eye at visit 3 and visit 4.
|
|---|---|---|---|---|
|
Ocular Itching
7 minutes post-challenge
|
0.56 score on a scale
Standard Deviation 0.856
|
0.72 score on a scale
Standard Deviation 0.885
|
1.75 score on a scale
Standard Deviation 0.971
|
1.97 score on a scale
Standard Deviation 0.984
|
|
Ocular Itching
3 minutes post-challenge
|
0.50 score on a scale
Standard Deviation 0.835
|
0.49 score on a scale
Standard Deviation 0.860
|
1.87 score on a scale
Standard Deviation 0.932
|
1.93 score on a scale
Standard Deviation 0.998
|
|
Ocular Itching
5 minutes post-challenge
|
0.56 score on a scale
Standard Deviation 0.785
|
0.69 score on a scale
Standard Deviation 0.923
|
1.90 score on a scale
Standard Deviation 0.936
|
2.17 score on a scale
Standard Deviation 0.885
|
PRIMARY outcome
Timeframe: 7, 15, and 20 minutes post challenge at 14 daysConjunctival 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 |
KetoNaph
n=72 eyes
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.
|
Ketotifen
n=71 eyes
Ketotifen fumarate 0.025% ophthalmic solution
Ketotifen: One drop of Ketotifen in study eye at visit 3 and visit 4.
|
Naphazoline
n=70 eyes
Naphazoline HCl 0.05% ophthalmic solution
Naphazoline: One drop of naphazoline in study eye at vist 3 and visit 4.
|
Vehicle
n=74 eyes
Vehicle of KetoNaph ophthalmic solution
Vehicle: One drop of vehicle in study eye at visit 3 and visit 4.
|
|---|---|---|---|---|
|
Conjunctival Hyperemia
15 minutes post-challenge
|
1.39 units on a scale
Standard Deviation 0.865
|
1.89 units on a scale
Standard Deviation 0.712
|
1.68 units on a scale
Standard Deviation 0.957
|
2.33 units on a scale
Standard Deviation 0.551
|
|
Conjunctival Hyperemia
20 minutes post-challenge
|
1.26 units on a scale
Standard Deviation 0.818
|
1.77 units on a scale
Standard Deviation 0.805
|
1.53 units on a scale
Standard Deviation 0.959
|
2.24 units on a scale
Standard Deviation 0.587
|
|
Conjunctival Hyperemia
7 minutes post-challenge
|
1.13 units on a scale
Standard Deviation 0.872
|
1.49 units on a scale
Standard Deviation 0.761
|
1.62 units on a scale
Standard Deviation 0.860
|
2.24 units on a scale
Standard Deviation 0.581
|
SECONDARY outcome
Timeframe: 7, 15, and 20 minutes post challenge at 14 daysPopulation: This outcome measure was not assessed for the Vehicle group.
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.
Outcome measures
| Measure |
KetoNaph
n=72 eyes
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.
|
Ketotifen
n=71 eyes
Ketotifen fumarate 0.025% ophthalmic solution
Ketotifen: One drop of Ketotifen in study eye at visit 3 and visit 4.
|
Naphazoline
n=70 eyes
Naphazoline HCl 0.05% ophthalmic solution
Naphazoline: One drop of naphazoline in study eye at vist 3 and visit 4.
|
Vehicle
Vehicle of KetoNaph ophthalmic solution
Vehicle: One drop of vehicle in study eye at visit 3 and visit 4.
|
|---|---|---|---|---|
|
Ciliary Redness
7 minutes post-challenge
|
1.05 units on a scale
Standard Deviation 0.873
|
1.39 units on a scale
Standard Deviation 0.774
|
1.66 units on a scale
Standard Deviation 0.917
|
—
|
|
Ciliary Redness
15 minutes post-challenge
|
1.28 units on a scale
Standard Deviation 0.907
|
1.79 units on a scale
Standard Deviation 0.791
|
1.71 units on a scale
Standard Deviation 0.995
|
—
|
|
Ciliary Redness
20 minutes post-challenge
|
1.15 units on a scale
Standard Deviation 0.854
|
1.77 units on a scale
Standard Deviation 0.810
|
1.58 units on a scale
Standard Deviation 1.032
|
—
|
SECONDARY outcome
Timeframe: 7, 15, and 20 minutes post challenge at 14 daysPopulation: This outcome measure was not assessed for the Vehicle group.
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.
Outcome measures
| Measure |
KetoNaph
n=72 eyes
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.
|
Ketotifen
n=71 eyes
Ketotifen fumarate 0.025% ophthalmic solution
Ketotifen: One drop of Ketotifen in study eye at visit 3 and visit 4.
|
Naphazoline
n=70 eyes
Naphazoline HCl 0.05% ophthalmic solution
Naphazoline: One drop of naphazoline in study eye at vist 3 and visit 4.
|
Vehicle
Vehicle of KetoNaph ophthalmic solution
Vehicle: One drop of vehicle in study eye at visit 3 and visit 4.
|
|---|---|---|---|---|
|
Episcleral Redness
15 minutes post-challenge
|
1.41 score on a scale
Standard Deviation 0.865
|
1.87 score on a scale
Standard Deviation 0.732
|
1.77 score on a scale
Standard Deviation 0.988
|
—
|
|
Episcleral Redness
7 minutes post-challenge
|
1.21 score on a scale
Standard Deviation 0.891
|
1.52 score on a scale
Standard Deviation 0.749
|
1.71 score on a scale
Standard Deviation 0.951
|
—
|
|
Episcleral Redness
20 minutes post-challenge
|
1.35 score on a scale
Standard Deviation 0.895
|
1.88 score on a scale
Standard Deviation 0.777
|
1.68 score on a scale
Standard Deviation 1.026
|
—
|
SECONDARY outcome
Timeframe: 7, 15, and 20 minutes post challenge at 14 daysPopulation: This outcome measure was not assessed for the Vehicle group.
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 |
KetoNaph
n=72 eyes
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.
|
Ketotifen
n=71 eyes
Ketotifen fumarate 0.025% ophthalmic solution
Ketotifen: One drop of Ketotifen in study eye at visit 3 and visit 4.
|
Naphazoline
n=70 eyes
Naphazoline HCl 0.05% ophthalmic solution
Naphazoline: One drop of naphazoline in study eye at vist 3 and visit 4.
|
Vehicle
Vehicle of KetoNaph ophthalmic solution
Vehicle: One drop of vehicle in study eye at visit 3 and visit 4.
|
|---|---|---|---|---|
|
Chemosis
7 minutes post-challenge
|
0.22 score on a scale
Standard Deviation 0.410
|
0.22 score on a scale
Standard Deviation 0.313
|
0.51 score on a scale
Standard Deviation 0.705
|
—
|
|
Chemosis
15 minutes post-challenge
|
0.29 score on a scale
Standard Deviation 0.488
|
0.42 score on a scale
Standard Deviation 0.420
|
0.66 score on a scale
Standard Deviation 0.787
|
—
|
|
Chemosis
20 minutes post-challenge
|
0.34 score on a scale
Standard Deviation 0.549
|
0.41 score on a scale
Standard Deviation 0.450
|
0.66 score on a scale
Standard Deviation 0.869
|
—
|
SECONDARY outcome
Timeframe: 7, 15, and 20 minutes post challenge at 14 daysPopulation: This outcome measure was not assessed for the Vehicle group.
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.
Outcome measures
| Measure |
KetoNaph
n=72 eyes
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.
|
Ketotifen
n=71 eyes
Ketotifen fumarate 0.025% ophthalmic solution
Ketotifen: One drop of Ketotifen in study eye at visit 3 and visit 4.
|
Naphazoline
n=70 eyes
Naphazoline HCl 0.05% ophthalmic solution
Naphazoline: One drop of naphazoline in study eye at vist 3 and visit 4.
|
Vehicle
Vehicle of KetoNaph ophthalmic solution
Vehicle: One drop of vehicle in study eye at visit 3 and visit 4.
|
|---|---|---|---|---|
|
Eyelid Swelling
20 minutes post-challenge
|
0.26 score on a scale
Standard Deviation 0.581
|
0.39 score on a scale
Standard Deviation 0.686
|
0.59 score on a scale
Standard Deviation 0.729
|
—
|
|
Eyelid Swelling
7 minutes post-challenge
|
0.13 score on a scale
Standard Deviation 0.373
|
0.32 score on a scale
Standard Deviation 0.604
|
0.61 score on a scale
Standard Deviation 0.783
|
—
|
|
Eyelid Swelling
15 minutes post-challenge
|
0.25 score on a scale
Standard Deviation 0.550
|
0.37 score on a scale
Standard Deviation 0.638
|
0.61 score on a scale
Standard Deviation 0.746
|
—
|
SECONDARY outcome
Timeframe: 7, 15, and 20 minutes post challenge at 14 daysPopulation: This outcome measure was not assessed for the Vehicle group.
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.
Outcome measures
| Measure |
KetoNaph
n=72 eyes
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.
|
Ketotifen
n=71 eyes
Ketotifen fumarate 0.025% ophthalmic solution
Ketotifen: One drop of Ketotifen in study eye at visit 3 and visit 4.
|
Naphazoline
n=70 eyes
Naphazoline HCl 0.05% ophthalmic solution
Naphazoline: One drop of naphazoline in study eye at vist 3 and visit 4.
|
Vehicle
Vehicle of KetoNaph ophthalmic solution
Vehicle: One drop of vehicle in study eye at visit 3 and visit 4.
|
|---|---|---|---|---|
|
Percentage of Eyes With Tearing
7 minutes post-challenge
|
3 eyes
|
11 eyes
|
23 eyes
|
—
|
|
Percentage of Eyes With Tearing
15 minutes post-challenge
|
6 eyes
|
7 eyes
|
16 eyes
|
—
|
|
Percentage of Eyes With Tearing
20 minutes post-challenge
|
5 eyes
|
7 eyes
|
13 eyes
|
—
|
SECONDARY outcome
Timeframe: 7, 15, and 20 minutes post challenge at 14 daysPopulation: This outcome measure was not assessed for the Vehicle group.
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 |
KetoNaph
n=72 eyes
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.
|
Ketotifen
n=71 eyes
Ketotifen fumarate 0.025% ophthalmic solution
Ketotifen: One drop of Ketotifen in study eye at visit 3 and visit 4.
|
Naphazoline
n=70 eyes
Naphazoline HCl 0.05% ophthalmic solution
Naphazoline: One drop of naphazoline in study eye at vist 3 and visit 4.
|
Vehicle
Vehicle of KetoNaph ophthalmic solution
Vehicle: One drop of vehicle in study eye at visit 3 and visit 4.
|
|---|---|---|---|---|
|
Percentage of Eyes With Ocular Mucus Drainage
15 minutes post-challenge
|
11 eyes
|
19 eyes
|
18 eyes
|
—
|
|
Percentage of Eyes With Ocular Mucus Drainage
20 minutes post-challenge
|
10 eyes
|
16 eyes
|
18 eyes
|
—
|
|
Percentage of Eyes With Ocular Mucus Drainage
7 minutes post-challenge
|
7 eyes
|
12 eyes
|
13 eyes
|
—
|
Adverse Events
KetoNaph
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ketotifen
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Naphazoline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vehicle
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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