Safety and Efficacy Study of a Eye Drop for Eye Allergy

• Sponsor: Vistakon Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00889330
• Collaborator: (none)
• Enrollment: 60
• Locations: 2
• Arms: 2
• Patients Per Site: 30

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of an anti-allergy eyedrop.

Condition or Disease	Intervention/Treatment	Phase
Allergic Conjunctivitis	Drug: alcaftadine; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: Apr 1, 2009
• Actual Primary Completion Date: May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: alcaftadine ophthalmic solution active treatment: administered as a single one-drop dose in each eye at each visit (Day 0 and Day 14).	Drug: alcaftadine; 0.25% Ophthalmic Solution, one drop in each eye at each of two visits.
Placebo Comparator: inactive ophthalmic solution vehicle Placebo, vehicle: administered as a single one-drop dose in each eye at each visit (Day 0 and Day 14).	Drug: Placebo; Vehicle without active, one drop in each eye at each of two visits.

Outcome Measures

Primary Outcome Measures

1. Ocular Itching at Visit 3 (Day 0) at 7 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation. [Visit 3 (Day 0) 16 hours post-dose, at up to 7 minutes following Allergen Challenge]

   A 0 to 4 scale used, allowing for half increment scores, where 0 indicates "none" and 4 indicates "incapacitating itch with an irresistible urge to rub"; measurement taken at up to 7 minutes following allergen challenge, 16 hours post treatment instillation.

2. Conjunctival Redness at Visit 3 (Day 0) at 20 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation [Visit 3 (Day 0) At 20 minutes following Allergen Challenge, 16 hours post-treatment]

   A 0 to 4 scale used, allowing for half increment scores to measure redness, where 0 indicates "none" and 4 indicates "extremely red"; measurement taken at 20 minutes following allergen challenge, 16 hours post treatment instillation.

3. Ocular Itching at Visit 4 (Day 14) at 7 Minutes Following Allergen Challenge, 15 Minutes Post- Treatment Instillation [Visit 4 (Day 14) up to 7 minutes following Allergen Challenge]

   0 to 4 scale, allowing for half increment scores, where 0 indicates "none" and 4 indicates "incapacitating itch with an irresistible urge to rub"

4. Conjunctival Redness at Visit 4 (Day 14) at 20 Minutes Following Allergen Challenge, 15 Minutes Post Treatment Instillation [Visit 4 (Day 14) At 20 minutes following Allergen Challenge]

   A 0 to 4 scale used, allowing for half increment scores to measure redness, where 0 indicates "none" and 4 indicates "extremely red"; measurement taken at 20 minutes following allergen challenge, 16 hours post treatment instillation.

Other Outcome Measures

1. Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day -14 [Visit 2 (Day -14) pre-allergen challenge]

   The number of eyes with any change in visual acuity measurements compared to Day -21.

2. Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge [Visit 3 (Day 0) pre-dose, pre-allergen challenge]

   The number of eyes with any change in visual acuity measurements compared to Day -21

3. Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge [Visit 4 (Day 14) pre-dose, pre-allergen challenge]

   The number of eyes with any change in visual acuity measurements compared to Day -21

4. Number of Eyes With a Undilated Fundoscopy Changes From Visit 1 (Day -21) at Day 14 [Visit 4 (Day 14) pre-dose, pre-allergen challenge]

   The number of eyes with any change to the following: Vitreous, Retina, Macula, Choroid, Optic Nerve

5. Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day -14 [Visit 2 (Day -14) pre-allergen challenge]

   The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus

6. Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge [Visit 3 (Day 0) pre-dose, pre-allergen challenge]

   The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus

7. Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Post-dose, Pre-allergen Challenge [Visit 3 (Day 0) post-dose, pre-allergen challenge]

   The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus

8. Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge [Visit 4 (Day 14) pre-dose, pre-allergen challenge]

   The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus

9. Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Post-dose, Pre-allergen Challenge [Visit 4 (Day 14) post-dose, pre-allergen challenge]

   The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• At least 10 years of age

• positive history of ocular allergies

• positive skin test reaction to allergens.

Exclusion Criteria:

• known allergy, contraindication, or sensitivities to the use of any of the study medication(s) or their components

• ocular surgical intervention within three (3) months prior to visit 1 or during the study

• known history of retinal detachment, diabetic retinopathy, or progressive retinal disease, or glaucoma

• any other significant illness

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Fairfield	Ohio	United States
2		Mason	Ohio	United States

Sponsors and Collaborators

• Vistakon Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vistakon Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00889330
• Other Study ID Numbers: 09-003-05
• First Posted: Apr 28, 2009
• Last Update Posted: Mar 6, 2015
• Last Verified: Feb 1, 2015

• Additional relevant MeSH terms: Conjunctivitis; Conjunctivitis, Allergic; Alcaftadine

Study Results

Participant Flow

Arm/Group Title	Alcaftadine Ophthalmic Solution	Inactive Vehicle Ophthalmic Solution
Arm/Group Description	active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.	inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
Period Title: Overall Study
STARTED	30	30
COMPLETED	30	30
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Alcaftadine Ophthalmic Solution	Inactive Vehicle Ophthalmic Solution	Total
Arm/Group Description	active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.	inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.	Total of all reporting groups
Overall Participants	30	30	60
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	37.8 (13.52)	34.3 (15.64)	36.1 (40)
Sex: Female, Male (Count of Participants)
Female	21 70%	15 50%	36 60%
Male	9 30%	15 50%	24 40%
Region of Enrollment (participants) [Number]
United States	30 100%	30 100%	60 100%

Outcome Measures

1. Primary Outcome

Title	Ocular Itching at Visit 3 (Day 0) at 7 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation.
Description	A 0 to 4 scale used, allowing for half increment scores, where 0 indicates "none" and 4 indicates "incapacitating itch with an irresistible urge to rub"; measurement taken at up to 7 minutes following allergen challenge, 16 hours post treatment instillation.
Time Frame	Visit 3 (Day 0) 16 hours post-dose, at up to 7 minutes following Allergen Challenge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Alcaftadine Ophthalmic Solution	Inactive Vehicle Ophthalmic Solution
Arm/Group Description	active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.	inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
Measure Participants	30	30
Mean (Standard Deviation) [units on a scale]	0.69 (0.691)	2.27 (0.970)

2. Primary Outcome

Title	Conjunctival Redness at Visit 3 (Day 0) at 20 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation
Description	A 0 to 4 scale used, allowing for half increment scores to measure redness, where 0 indicates "none" and 4 indicates "extremely red"; measurement taken at 20 minutes following allergen challenge, 16 hours post treatment instillation.
Time Frame	Visit 3 (Day 0) At 20 minutes following Allergen Challenge, 16 hours post-treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Alcaftadine Ophthalmic Solution	Inactive Vehicle Ophthalmic Solution
Arm/Group Description	active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.	inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
Measure Participants	30	30
Mean (Standard Deviation) [units on a scale]	1.96 (0.846)	2.50 (0.579)

3. Primary Outcome

Title	Ocular Itching at Visit 4 (Day 14) at 7 Minutes Following Allergen Challenge, 15 Minutes Post- Treatment Instillation
Description	0 to 4 scale, allowing for half increment scores, where 0 indicates "none" and 4 indicates "incapacitating itch with an irresistible urge to rub"
Time Frame	Visit 4 (Day 14) up to 7 minutes following Allergen Challenge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Alcaftadine Ophthalmic Solution	Inactive Vehicle Ophthalmic Solution
Arm/Group Description	active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.	inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
Measure Participants	30	30
Mean (Standard Deviation) [units on a scale]	0.42 (0.509)	1.90 (1.058)

4. Primary Outcome

Title	Conjunctival Redness at Visit 4 (Day 14) at 20 Minutes Following Allergen Challenge, 15 Minutes Post Treatment Instillation
Description	A 0 to 4 scale used, allowing for half increment scores to measure redness, where 0 indicates "none" and 4 indicates "extremely red"; measurement taken at 20 minutes following allergen challenge, 16 hours post treatment instillation.
Time Frame	Visit 4 (Day 14) At 20 minutes following Allergen Challenge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Alcaftadine Ophthalmic Solution	Inactive Vehicle Ophthalmic Solution
Arm/Group Description	active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.	inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
Measure Participants	30	30
Mean (Standard Deviation) [units on a scale]	1.57 (0.863)	2.15 (0.822)

5. Other Pre-specified Outcome

Title	Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day -14
Description	The number of eyes with any change in visual acuity measurements compared to Day -21.
Time Frame	Visit 2 (Day -14) pre-allergen challenge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Alcaftadine Ophthalmic Solution	Inactive Vehicle Ophthalmic Solution
Arm/Group Description	active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.	inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
Measure Participants	30	30
Measure eyes	60	60
Number [eyes]	0	1

6. Other Pre-specified Outcome

Title	Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge
Description	The number of eyes with any change in visual acuity measurements compared to Day -21
Time Frame	Visit 3 (Day 0) pre-dose, pre-allergen challenge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Alcaftadine Ophthalmic Solution	Inactive Vehicle Ophthalmic Solution
Arm/Group Description	active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.	inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
Measure Participants	30	30
Measure eyes	60	60
Number [eyes]	1	0

7. Other Pre-specified Outcome

Title	Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge
Description	The number of eyes with any change in visual acuity measurements compared to Day -21
Time Frame	Visit 4 (Day 14) pre-dose, pre-allergen challenge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Alcaftadine Ophthalmic Solution	Inactive Vehicle Ophthalmic Solution
Arm/Group Description	active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.	inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
Measure Participants	30	30
Measure eyes	60	60
Number [eyes]	0	1

8. Other Pre-specified Outcome

Title	Number of Eyes With a Undilated Fundoscopy Changes From Visit 1 (Day -21) at Day 14
Description	The number of eyes with any change to the following: Vitreous, Retina, Macula, Choroid, Optic Nerve
Time Frame	Visit 4 (Day 14) pre-dose, pre-allergen challenge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Alcaftadine Ophthalmic Solution	Inactive Vehicle Ophthalmic Solution
Arm/Group Description	active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.	inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
Measure Participants	30	30
Measure eyes	60	60
Vitreous	0	0
Retina	0	0
Macula	0	0
Choroid	0	0
Optic Nerve	0	0

9. Other Pre-specified Outcome

Title	Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day -14
Description	The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus
Time Frame	Visit 2 (Day -14) pre-allergen challenge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Alcaftadine Ophthalmic Solution	Inactive Vehicle Ophthalmic Solution
Arm/Group Description	active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.	inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
Measure Participants	30	30
Measure eyes	60	60
anterior chamber	0	0
conjunctiva	0	0
cornea	0	0
iris	0	0
lens	0	0
lids	0	0
tear meniscus	0	0

10. Other Pre-specified Outcome

Title	Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge
Description	The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus
Time Frame	Visit 3 (Day 0) pre-dose, pre-allergen challenge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Alcaftadine Ophthalmic Solution	Inactive Vehicle Ophthalmic Solution
Arm/Group Description	active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.	inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
Measure Participants	30	30
Measure eyes	60	60
anterior chamber	0	0
conjunctiva	0	0
cornea	0	0
iris	0	0
lens	0	0
lids	1	0
tear meniscus	0	0

11. Other Pre-specified Outcome

Title	Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Post-dose, Pre-allergen Challenge
Description	The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus
Time Frame	Visit 3 (Day 0) post-dose, pre-allergen challenge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Alcaftadine Ophthalmic Solution	Inactive Vehicle Ophthalmic Solution
Arm/Group Description	active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.	inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
Measure Participants	30	30
Measure eyes	60	60
anterior chamber	0	0
conjunctiva	0	0
cornea	0	0
iris	0	0
lens	0	0
lids	1	0
tear meniscus	0	0

12. Other Pre-specified Outcome

Title	Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge
Description	The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus
Time Frame	Visit 4 (Day 14) pre-dose, pre-allergen challenge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Alcaftadine Ophthalmic Solution	Inactive Vehicle Ophthalmic Solution
Arm/Group Description	active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.	inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
Measure Participants	30	30
Measure eyes	60	60
anterior chamber	0	0
conjunctiva	0	0
cornea	0	0
iris	0	0
lens	0	0
lids	1	0
tear meniscus	0	0

13. Other Pre-specified Outcome

Title	Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Post-dose, Pre-allergen Challenge
Description	The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus
Time Frame	Visit 4 (Day 14) post-dose, pre-allergen challenge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Alcaftadine Ophthalmic Solution	Inactive Vehicle Ophthalmic Solution
Arm/Group Description	active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.	inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
Measure Participants	30	30
Measure eyes	60	60
anterior chamber	0	0
conjunctiva	0	0
cornea	0	0
iris	0	0
lens	0	0
lids	1	0
tear meniscus	0	0

Adverse Events

Arm/Group Title	Alcaftadine Ophthalmic Solution		Inactive Vehicle Ophthalmic Solution
Arm/Group Description	active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.		inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
All Cause Mortality
	Alcaftadine Ophthalmic Solution		Inactive Vehicle Ophthalmic Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Alcaftadine Ophthalmic Solution		Inactive Vehicle Ophthalmic Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Alcaftadine Ophthalmic Solution		Inactive Vehicle Ophthalmic Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.