Safety and Efficacy Study of a Eye Drop for Eye Allergy

Allergic Conjunctivitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00889330
• Other study ID #: 09-003-05
• Status: Completed
• Phase: Phase 3
• First received: April 24, 2009
• Last updated: February 18, 2015
• Start date: April 2009

Study information

• Verified date: February 2015
• Source: Vistakon Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• alcaftadine
0.25% Ophthalmic Solution, one drop in each eye at each of two visits.
• Placebo
Vehicle without active, one drop in each eye at each of two visits.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vistakon Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day -14	The number of eyes with any change in visual acuity measurements compared to Day -21.	Visit 2 (Day -14) pre-allergen challenge	Yes
Other	Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge	The number of eyes with any change in visual acuity measurements compared to Day -21	Visit 3 (Day 0) pre-dose, pre-allergen challenge	Yes
Other	Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge	The number of eyes with any change in visual acuity measurements compared to Day -21	Visit 4 (Day 14) pre-dose, pre-allergen challenge	Yes
Other	Number of Eyes With a Undilated Fundoscopy Changes From Visit 1 (Day -21) at Day 14	The number of eyes with any change to the following: Vitreous, Retina, Macula, Choroid, Optic Nerve	Visit 4 (Day 14) pre-dose, pre-allergen challenge	Yes
Other	Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day -14	The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus	Visit 2 (Day -14) pre-allergen challenge	Yes
Other	Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at 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	Visit 3 (Day 0) pre-dose, pre-allergen challenge	Yes
Other	Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at 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	Visit 3 (Day 0) post-dose, pre-allergen challenge	Yes
Other	Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at 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	Visit 4 (Day 14) pre-dose, pre-allergen challenge	Yes
Other	Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at 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	Visit 4 (Day 14) post-dose, pre-allergen challenge	Yes
Primary	Ocular Itching at Visit 3 (Day 0) at 7 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation.	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.	Visit 3 (Day 0) 16 hours post-dose, at up to 7 minutes following Allergen Challenge	No
Primary	Conjunctival Redness at Visit 3 (Day 0) at 20 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation	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.	Visit 3 (Day 0) At 20 minutes following Allergen Challenge, 16 hours post-treatment	No
Primary	Ocular Itching at Visit 4 (Day 14) at 7 Minutes Following Allergen Challenge, 15 Minutes Post- Treatment Instillation	0 to 4 scale, allowing for half increment scores, where 0 indicates "none" and 4 indicates "incapacitating itch with an irresistible urge to rub"	Visit 4 (Day 14) up to 7 minutes following Allergen Challenge	No
Primary	Conjunctival Redness at Visit 4 (Day 14) at 20 Minutes Following Allergen Challenge, 15 Minutes Post Treatment Instillation	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.	Visit 4 (Day 14) At 20 minutes following Allergen Challenge	No