Trial Outcomes & Findings for A Single-Center Evaluation of the Anti-Inflammatory Effects of Lastacaft as Measured by In-Vivo Confocal Microscopy (NCT NCT02308501)

Last Updated: 2021-03-18

Results Overview

Conjunctival Inflammation was assessed by a trained technician post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0 = best \[least inflammation\] and 4 = worst \[most inflammation\]). The Conjunctival Inflammation was averaged across all Lastacaft-treated eyes to create the average Lastacaft eye Conjunctival Inflammation score, and the Conjunctival Inflammation score was averaged across all Tears Naturale-treated eyes to create the average Tears Naturale eye Conjunctival Inflammation score.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

25 participants

Primary outcome timeframe

1 hour (+30 minutes) post CAC on Day 1

Results posted on

2021-03-18

Participant Flow

Subjects were recruited from one site in the US.

Twenty-five participants enrolled and completed the study. Participant flow and baseline characteristics are presented for the 25 subjects (50 participant eyes) that met all inclusion criteria, none of the exclusion criteria and were randomized to receive Lastacaft ® in one eye (25 participant eyes) and Tears Naturale ® (25 participant eyes) in the other based on the randomization list.

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	Lastacaft ® One drop Lastacaft ® in right eye or left eye based on randomization list once on Day 1 and once on Day 2. If the right eye was selected for Lastacaft ® at Day 1, the right eye also received Lastacaft ® at Day 2 as dosing did not change between days.	Tears Naturale ® (Placebo) One drop Tears Naturale® (Placebo) in right eye or left eye based on randomization list once on Day 1 and once on Day 2. If the right eye was selected for Tears Naturale® (Placebo) at Day 1, the right eye also received Tears Naturale® (Placebo) at Day 2 as dosing did not change between days.
Overall Study STARTED	25 25	25 25
Overall Study Randomized Participant Eyes	25 25	25 25
Overall Study COMPLETED	25 25	25 25
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Single-Center Evaluation of the Anti-Inflammatory Effects of Lastacaft as Measured by In-Vivo Confocal Microscopy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lastacaft ® Eyes n=25 Eyes One drop Lastacaft ® in right eye or left eye based on randomization list once on Day 1 and once on Day 2. If the right eye was selected for Lastacaft ® at Day 1, the right eye also received Lastacaft ® at Day 2 as dosing did not change between days.	Tears Naturale® Eyes n=25 Eyes One drop Tears Naturale® (Placebo) in right eye or left eye based on randomization list once on Day 1 and once on Day 2. If the right eye was selected for Tears Naturale® (Placebo) at Day 1, the right eye also received Tears Naturale® (Placebo) at Day 2 as dosing did not change between days	Total n=50 Eyes Total of all reporting groups
Age, Categorical <=18 years	0 Eyes n=14 Eyes	0 Eyes n=23 Eyes	0 Eyes n=50 Eyes
Age, Categorical Between 18 and 65 years	22 Eyes n=14 Eyes	22 Eyes n=23 Eyes	44 Eyes n=50 Eyes
Age, Categorical >=65 years	3 Eyes n=14 Eyes	3 Eyes n=23 Eyes	6 Eyes n=50 Eyes
Sex: Female, Male Female	9 Eyes n=14 Eyes	9 Eyes n=23 Eyes	18 Eyes n=50 Eyes
Sex: Female, Male Male	16 Eyes n=14 Eyes	16 Eyes n=23 Eyes	32 Eyes n=50 Eyes
Race (NIH/OMB) American Indian or Alaska Native	0 Eyes n=14 Eyes	0 Eyes n=23 Eyes	0 Eyes n=50 Eyes
Race (NIH/OMB) Asian	0 Eyes n=14 Eyes	0 Eyes n=23 Eyes	0 Eyes n=50 Eyes
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Eyes n=14 Eyes	1 Eyes n=23 Eyes	2 Eyes n=50 Eyes
Race (NIH/OMB) Black or African American	0 Eyes n=14 Eyes	0 Eyes n=23 Eyes	0 Eyes n=50 Eyes
Race (NIH/OMB) White	21 Eyes n=14 Eyes	21 Eyes n=23 Eyes	42 Eyes n=50 Eyes
Race (NIH/OMB) More than one race	0 Eyes n=14 Eyes	0 Eyes n=23 Eyes	0 Eyes n=50 Eyes
Race (NIH/OMB) Unknown or Not Reported	3 Eyes n=14 Eyes	3 Eyes n=23 Eyes	6 Eyes n=50 Eyes
Region of Enrollment United States	25 Eyes n=14 Eyes	25 Eyes n=23 Eyes	50 Eyes n=50 Eyes

PRIMARY outcome

Timeframe: 1 hour (+30 minutes) post CAC on Day 1

Population: All Randomized Participants Population - All participants who received study treatment

Outcome measures

Outcome measures
Measure	Lastacaft® n=25 Eyes Participants received one drop of Lastacaft® or Tears Naturale ® (Placebo) in right eye and one drop of the other treatment in the left eye once on Day 1 based on the randomization list. (participants that received Lastacaft ® in one eye received Tears Naturale® in the other eye at the same time). If the right eye was selected for Lastacaft ® at Day 1, the right eye also received Lastacaft ® at Day 2 as dosing did not change between days.	Tears Naturale ® (Placebo) n=25 Eyes Participants received one drop of Lastacaft® or Tears Naturale ® (Placebo) in right eye and one drop of the other treatment in the left eye once on Day 1 based on the randomization list. (participants that received Tears Naturale ® in one eye received Lastacaft® in the other eye at the same time). If the right eye was selected for Lastacaft ® at Day 1, the right eye also received Lastacaft ® at Day 2 as dosing did not change between days.
Conjunctival Inflammation at 1 Hour (+30 Minutes) Post CAC on Day 1	3.12 units on a scale Standard Deviation 0.79	3.02 units on a scale Standard Deviation 0.80

PRIMARY outcome

Timeframe: 1 hour (+30 minutes) post CAC on Day 2

Population: All Randomized Participants Population - All participants who received study treatment

Outcome measures

Outcome measures
Measure	Lastacaft® n=25 Eyes Participants received one drop of Lastacaft® or Tears Naturale ® (Placebo) in right eye and one drop of the other treatment in the left eye once on Day 1 based on the randomization list. (participants that received Lastacaft ® in one eye received Tears Naturale® in the other eye at the same time). If the right eye was selected for Lastacaft ® at Day 1, the right eye also received Lastacaft ® at Day 2 as dosing did not change between days.	Tears Naturale ® (Placebo) n=25 Eyes Participants received one drop of Lastacaft® or Tears Naturale ® (Placebo) in right eye and one drop of the other treatment in the left eye once on Day 1 based on the randomization list. (participants that received Tears Naturale ® in one eye received Lastacaft® in the other eye at the same time). If the right eye was selected for Lastacaft ® at Day 1, the right eye also received Lastacaft ® at Day 2 as dosing did not change between days.
Conjunctival Inflammation 1 Hour (+30 Minutes) Post CAC on Day 2	2.44 units on a scale Standard Deviation 0.97	2.90 units on a scale Standard Deviation 0.96

SECONDARY outcome

Timeframe: 15 minutes post-study medication instillation

Population: All Randomized Participants Population - All participants who received study treatment

CAC was performed 15 minutes after study medication instillation. Ocular Itching was assessed by the patient on a 0-4 scale (0 = best \[no itching\] to 4 = worst \[severe itching\]). The ocular itching score was averaged across all Lastacaft-treated eyes to create the average Lastacaft eye ocular itching score, and the ocular itching score was averaged across all Tears Naturale-treated eyes to create the average Tears Naturale eye ocular itching score.

Outcome measures

Outcome measures
Measure	Lastacaft® n=25 Eyes Participants received one drop of Lastacaft® or Tears Naturale ® (Placebo) in right eye and one drop of the other treatment in the left eye once on Day 1 based on the randomization list. (participants that received Lastacaft ® in one eye received Tears Naturale® in the other eye at the same time). If the right eye was selected for Lastacaft ® at Day 1, the right eye also received Lastacaft ® at Day 2 as dosing did not change between days.	Tears Naturale ® (Placebo) n=25 Eyes Participants received one drop of Lastacaft® or Tears Naturale ® (Placebo) in right eye and one drop of the other treatment in the left eye once on Day 1 based on the randomization list. (participants that received Tears Naturale ® in one eye received Lastacaft® in the other eye at the same time). If the right eye was selected for Lastacaft ® at Day 1, the right eye also received Lastacaft ® at Day 2 as dosing did not change between days.
Ocular Itching on Day 1 (15 Minutes Post-study Medication Instillation) 3 minutes post-CAC	0.72 units on a scale Standard Deviation 0.91	2.19 units on a scale Standard Deviation 0.93
Ocular Itching on Day 1 (15 Minutes Post-study Medication Instillation) 5 minutes post-CAC	0.88 units on a scale Standard Deviation 0.92	2.41 units on a scale Standard Deviation 0.86
Ocular Itching on Day 1 (15 Minutes Post-study Medication Instillation) 7 minutes post-CAC	0.91 units on a scale Standard Deviation 0.93	2.38 units on a scale Standard Deviation 0.90

SECONDARY outcome

Timeframe: 15 minutes post-study medication instillation

Population: All Randomized Participants Population - All participants who received study treatment

Outcome measures

Outcome measures
Measure	Lastacaft® n=25 Eyes Participants received one drop of Lastacaft® or Tears Naturale ® (Placebo) in right eye and one drop of the other treatment in the left eye once on Day 1 based on the randomization list. (participants that received Lastacaft ® in one eye received Tears Naturale® in the other eye at the same time). If the right eye was selected for Lastacaft ® at Day 1, the right eye also received Lastacaft ® at Day 2 as dosing did not change between days.	Tears Naturale ® (Placebo) n=25 Eyes Participants received one drop of Lastacaft® or Tears Naturale ® (Placebo) in right eye and one drop of the other treatment in the left eye once on Day 1 based on the randomization list. (participants that received Tears Naturale ® in one eye received Lastacaft® in the other eye at the same time). If the right eye was selected for Lastacaft ® at Day 1, the right eye also received Lastacaft ® at Day 2 as dosing did not change between days.
Ocular Itching on Day 2 (15 Minutes Post-study Medication Instillation) 3 minutes post-CAC	0.84 units on a scale Standard Deviation 0.89	2.00 units on a scale Standard Deviation 1.02
Ocular Itching on Day 2 (15 Minutes Post-study Medication Instillation) 5 minutes post-CAC	1.16 units on a scale Standard Deviation 0.87	2.22 units on a scale Standard Deviation 0.71
Ocular Itching on Day 2 (15 Minutes Post-study Medication Instillation) 7 minutes post-CAC	1.19 units on a scale Standard Deviation 0.85	2.22 units on a scale Standard Deviation 0.71

Adverse Events

Lastacaft®

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Tears Naturale ® (Placebo)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Lastacaft® n=25 participants at risk Participants received one drop of Lastacaft® or Tears Naturale ® (Placebo) in right eye and one drop of Lastacaft® or Tears Naturale ® (Placebo) in left eye based on the randomization list. (participants that received Lastacaft ® in one eye received Tears Naturale® in the other eye at the same time)	Tears Naturale ® (Placebo) n=25 participants at risk Participants received one drop of Lastacaft® or Tears Naturale ® (Placebo) in right eye and one drop of Lastacaft® or Tears Naturale ® (Placebo) in left eye based on the randomization list. (participants that received Tears Naturale ® in one eye received Lastacaft ® in the other eye at the same time)
Eye disorders filmy sensation	4.0% 1/25 • Number of events 1 • Adverse events were collected through study completion, an average of 5 days. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	4.0% 1/25 • Number of events 1 • Adverse events were collected through study completion, an average of 5 days. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.
Eye disorders blurred vision	4.0% 1/25 • Number of events 1 • Adverse events were collected through study completion, an average of 5 days. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	4.0% 1/25 • Number of events 1 • Adverse events were collected through study completion, an average of 5 days. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.
Eye disorders decreased visual acuity	4.0% 1/25 • Number of events 1 • Adverse events were collected through study completion, an average of 5 days. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	4.0% 1/25 • Number of events 1 • Adverse events were collected through study completion, an average of 5 days. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.

Additional Information

Caitlin Pearson

Ora

Phone: 978-685-8900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place