Trial Outcomes & Findings for Safety and Efficacy Study of a Eye Drop for Eye Allergy (NCT NCT00889330)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

60 participants

Primary outcome timeframe

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

Results posted on

2015-03-06

Participant Flow

Participant milestones

Participant milestones
Measure	Alcaftadine Ophthalmic Solution active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.	Inactive Vehicle Ophthalmic Solution inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy Study of a Eye Drop for Eye Allergy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Alcaftadine Ophthalmic Solution n=30 Participants active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.	Inactive Vehicle Ophthalmic Solution n=30 Participants inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.	Total n=60 Participants Total of all reporting groups
Age, Continuous	37.8 years STANDARD_DEVIATION 13.52 • n=5 Participants	34.3 years STANDARD_DEVIATION 15.64 • n=7 Participants	36.1 years STANDARD_DEVIATION 40 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	15 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	15 Participants n=7 Participants	24 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Alcaftadine Ophthalmic Solution n=30 Participants active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.	Inactive Vehicle Ophthalmic Solution n=30 Participants inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
Ocular Itching at Visit 3 (Day 0) at 7 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation.	0.69 units on a scale Standard Deviation 0.691	2.27 units on a scale Standard Deviation 0.970

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Alcaftadine Ophthalmic Solution n=30 Participants active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.	Inactive Vehicle Ophthalmic Solution n=30 Participants inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
Conjunctival Redness at Visit 3 (Day 0) at 20 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation	1.96 units on a scale Standard Deviation 0.846	2.50 units on a scale Standard Deviation 0.579

PRIMARY outcome

Timeframe: 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"

Outcome measures

Outcome measures
Measure	Alcaftadine Ophthalmic Solution n=30 Participants active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.	Inactive Vehicle Ophthalmic Solution n=30 Participants inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
Ocular Itching at Visit 4 (Day 14) at 7 Minutes Following Allergen Challenge, 15 Minutes Post- Treatment Instillation	0.42 units on a scale Standard Deviation 0.509	1.90 units on a scale Standard Deviation 1.058

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Alcaftadine Ophthalmic Solution n=30 Participants active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.	Inactive Vehicle Ophthalmic Solution n=30 Participants inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
Conjunctival Redness at Visit 4 (Day 14) at 20 Minutes Following Allergen Challenge, 15 Minutes Post Treatment Instillation	1.57 units on a scale Standard Deviation 0.863	2.15 units on a scale Standard Deviation 0.822

OTHER_PRE_SPECIFIED outcome

Timeframe: Visit 2 (Day -14) pre-allergen challenge

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

Outcome measures

Outcome measures
Measure	Alcaftadine Ophthalmic Solution n=30 Participants active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.	Inactive Vehicle Ophthalmic Solution n=60 eyes inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day -14	0 eyes	1 eyes

OTHER_PRE_SPECIFIED outcome

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

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

Outcome measures

Outcome measures
Measure	Alcaftadine Ophthalmic Solution n=60 eyes active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.	Inactive Vehicle Ophthalmic Solution n=60 eyes inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge	1 eyes	0 eyes

OTHER_PRE_SPECIFIED outcome

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

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

Outcome measures

Outcome measures
Measure	Alcaftadine Ophthalmic Solution n=60 eyes active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.	Inactive Vehicle Ophthalmic Solution n=60 eyes inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge	0 eyes	1 eyes

OTHER_PRE_SPECIFIED outcome

Timeframe: 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