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CompletedNCT00889330Updated Mar 6, 2015Results posted

Safety and Efficacy Study of a Eye Drop for Eye Allergy

A Phase 3 interventional study of alcaftadine and Placebo in Allergic Conjunctivitis, sponsored by Vistakon Pharmaceuticals. Completed at 2 sites in United States. Open to participants aged 10 Years and older. Per ClinicalTrials.gov, last updated 2015-03-06.

Sponsored by Vistakon Pharmaceuticals · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
10 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Allergic Conjunctivitis
03

In context

Conjunctivitis

361 studies on the registry are indexed under Conjunctivitis; 17 are open to participants now.

This study's enrollment of 60 is below the median of 100 across 299 interventional studies indexed under Conjunctivitis.

Browse Conjunctivitis studies →

Lead sponsor

Vistakon Pharmaceuticals is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Drugalcaftadine

    0.25% Ophthalmic Solution, one drop in each eye at each of two visits.

  • DrugPlacebo

    Vehicle without active, one drop in each eye at each of two visits.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Visit 3 (Day 0) 16 hours post-dose, at up to 7 minutes following Allergen Challenge

  2. 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.

    Time frame: Visit 3 (Day 0) At 20 minutes following Allergen Challenge, 16 hours post-treatment

  3. 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"

    Time frame: Visit 4 (Day 14) up to 7 minutes following Allergen Challenge

  4. 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.

    Time frame: Visit 4 (Day 14) At 20 minutes following Allergen Challenge

Other outcomes

  1. 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.

    Time frame: Visit 2 (Day -14) pre-allergen challenge

  2. 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

    Time frame: Visit 3 (Day 0) pre-dose, pre-allergen challenge

  3. 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

    Time frame: Visit 4 (Day 14) pre-dose, pre-allergen challenge

  4. 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

    Time frame: Visit 4 (Day 14) pre-dose, pre-allergen challenge

  5. 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

    Time frame: Visit 2 (Day -14) pre-allergen challenge

  6. 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

    Time frame: Visit 3 (Day 0) pre-dose, pre-allergen challenge

  7. 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

    Time frame: Visit 3 (Day 0) post-dose, pre-allergen challenge

  8. 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

    Time frame: Visit 4 (Day 14) pre-dose, pre-allergen challenge

  9. 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

    Time frame: Visit 4 (Day 14) post-dose, pre-allergen challenge

07

Results

Posted Dec 8, 2011

Participant flow

Participant flow — Overall Study
MilestoneAlcaftadine Ophthalmic SolutionInactive Vehicle Ophthalmic Solution
Started3030
Completed3030
Not completed00

Outcome measures

PrimaryOcular 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.

Time frame:
Visit 3 (Day 0) 16 hours post-dose, at up to 7 minutes following Allergen Challenge
Reported as:
Mean · units on a scale
Ocular Itching at Visit 3 (Day 0) at 7 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation.
units on a scaleAlcaftadine Ophthalmic SolutionInactive Vehicle Ophthalmic Solution
Ocular Itching at Visit 3 (Day 0) at 7 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation.0.69 ± 0.6912.27 ± 0.970
PrimaryConjunctival 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.

Time frame:
Visit 3 (Day 0) At 20 minutes following Allergen Challenge, 16 hours post-treatment
Reported as:
Mean · units on a scale
Conjunctival Redness at Visit 3 (Day 0) at 20 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation
units on a scaleAlcaftadine Ophthalmic SolutionInactive Vehicle Ophthalmic Solution
Conjunctival Redness at Visit 3 (Day 0) at 20 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation1.96 ± 0.8462.50 ± 0.579
PrimaryOcular 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"

Time frame:
Visit 4 (Day 14) up to 7 minutes following Allergen Challenge
Reported as:
Mean · units on a scale
Ocular Itching at Visit 4 (Day 14) at 7 Minutes Following Allergen Challenge, 15 Minutes Post- Treatment Instillation
units on a scaleAlcaftadine Ophthalmic SolutionInactive Vehicle Ophthalmic Solution
Ocular Itching at Visit 4 (Day 14) at 7 Minutes Following Allergen Challenge, 15 Minutes Post- Treatment Instillation0.42 ± 0.5091.90 ± 1.058
PrimaryConjunctival 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.

Time frame:
Visit 4 (Day 14) At 20 minutes following Allergen Challenge
Reported as:
Mean · units on a scale
Conjunctival Redness at Visit 4 (Day 14) at 20 Minutes Following Allergen Challenge, 15 Minutes Post Treatment Instillation
units on a scaleAlcaftadine Ophthalmic SolutionInactive Vehicle Ophthalmic Solution
Conjunctival Redness at Visit 4 (Day 14) at 20 Minutes Following Allergen Challenge, 15 Minutes Post Treatment Instillation1.57 ± 0.8632.15 ± 0.822
Other pre-specifiedNumber 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.

Time frame:
Visit 2 (Day -14) pre-allergen challenge
Reported as:
Number · eyes
Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day -14
eyesAlcaftadine Ophthalmic SolutionInactive Vehicle Ophthalmic Solution
Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day -1401
Other pre-specifiedNumber 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

Time frame:
Visit 3 (Day 0) pre-dose, pre-allergen challenge
Reported as:
Number · eyes
Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge
eyesAlcaftadine Ophthalmic SolutionInactive Vehicle Ophthalmic Solution
Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge10
Other pre-specifiedNumber 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

Time frame:
Visit 4 (Day 14) pre-dose, pre-allergen challenge
Reported as:
Number · eyes
Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge
eyesAlcaftadine Ophthalmic SolutionInactive Vehicle Ophthalmic Solution
Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge01
Other pre-specifiedNumber 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

Time frame:
Visit 4 (Day 14) pre-dose, pre-allergen challenge
Reported as:
Number · eyes
Number of Eyes With a Undilated Fundoscopy Changes From Visit 1 (Day -21) at Day 14
eyesAlcaftadine Ophthalmic SolutionInactive Vehicle Ophthalmic Solution
Vitreous00
Retina00
Macula00
Choroid00
Optic Nerve00
Other pre-specifiedNumber 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

Time frame:
Visit 2 (Day -14) pre-allergen challenge
Reported as:
Number · eyes
Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day -14
eyesAlcaftadine Ophthalmic SolutionInactive Vehicle Ophthalmic Solution
anterior chamber00
conjunctiva00
cornea00
iris00
lens00
lids00
tear meniscus00
Other pre-specifiedNumber 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

Time frame:
Visit 3 (Day 0) pre-dose, pre-allergen challenge
Reported as:
Number · eyes
Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge
eyesAlcaftadine Ophthalmic SolutionInactive Vehicle Ophthalmic Solution
anterior chamber00
conjunctiva00
cornea00
iris00
lens00
lids10
tear meniscus00
Other pre-specifiedNumber 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

Time frame:
Visit 3 (Day 0) post-dose, pre-allergen challenge
Reported as:
Number · eyes
Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Post-dose, Pre-allergen Challenge
eyesAlcaftadine Ophthalmic SolutionInactive Vehicle Ophthalmic Solution
anterior chamber00
conjunctiva00
cornea00
iris00
lens00
lids10
tear meniscus00
Other pre-specifiedNumber 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

Time frame:
Visit 4 (Day 14) pre-dose, pre-allergen challenge
Reported as:
Number · eyes
Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge
eyesAlcaftadine Ophthalmic SolutionInactive Vehicle Ophthalmic Solution
anterior chamber00
conjunctiva00
cornea00
iris00
lens00
lids10
tear meniscus00
Other pre-specifiedNumber 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

Time frame:
Visit 4 (Day 14) post-dose, pre-allergen challenge
Reported as:
Number · eyes
Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Post-dose, Pre-allergen Challenge
eyesAlcaftadine Ophthalmic SolutionInactive Vehicle Ophthalmic Solution
anterior chamber00
conjunctiva00
cornea00
iris00
lens00
lids10
tear meniscus00

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Alcaftadine Ophthalmic Solution—0/30 (0%)0/30 (0%)
Inactive Vehicle Ophthalmic Solution—0/30 (0%)0/30 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Alcaftadine Ophthalmic SolutionInactive Vehicle Ophthalmic SolutionTotal
Mean37.8 ± 13.5234.3 ± 15.6436.1 ± 40
Sex: Female, Male
Sex: Female, Male(Participants)Alcaftadine Ophthalmic SolutionInactive Vehicle Ophthalmic SolutionTotal
Female211536
Male91524
Region of Enrollment
Region of Enrollment(participants)Alcaftadine Ophthalmic SolutionInactive Vehicle Ophthalmic SolutionTotal
United States303060
08

Study locations

2 sites
  • Fairfield, Ohio, United States
  • Mason, Ohio, United States
09

References and documents

Publications

  • Torkildsen G, Shedden A. The safety and efficacy of alcaftadine 0.25% ophthalmic solution for the prevention of itching associated with allergic conjunctivitis. Curr Med Res Opin. 2011 Mar;27(3):623-31. doi: 10.1185/03007995.2010.548797. Epub 2011 Jan 21. PubMed 21250860 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00889330
Lead sponsor
Vistakon Pharmaceuticals
Responsible party
Sponsor
First posted
Apr 28, 2009
Start date
Apr 2009
Primary completion
May 2009
Results posted
Dec 8, 2011
Last update
Mar 6, 2015
View the source record on ClinicalTrials.gov ↗

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