Trial Outcomes & Findings for Safety and Efficacy Study of Cyclosporine Ophthalmic Emulsion in Post-LASIK Patients (NCT NCT00611403)

Results Overview

Percentage of patients with clinical success at month 6. Clinical success is defined as the percentage of patients with corneal sensitivity (the capability of the cornea to respond to stimulation) \>= 50 millimeters in all regions of the study eye at month 6 of the Treatment Phase.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

137 participants

Primary outcome timeframe

Month 6

Results posted on

2011-12-20

Participant Flow

Participant milestones

Participant milestones
Measure	RESTASIS® Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)	REFRESH ENDURA® Artificial Tears (REFRESH ENDURA®)
Treatment Phase STARTED	68	69
Treatment Phase COMPLETED	62	58
Treatment Phase NOT COMPLETED	6	11
Post Treatment Extension Phase STARTED	26	25
Post Treatment Extension Phase COMPLETED	22	24
Post Treatment Extension Phase NOT COMPLETED	4	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy Study of Cyclosporine Ophthalmic Emulsion in Post-LASIK Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RESTASIS® n=68 Participants Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)	REFRESH ENDURA® n=69 Participants Artificial Tears (REFRESH ENDURA®)	Total n=137 Participants Total of all reporting groups
Age, Customized < 30 years	19 participants n=5 Participants	21 participants n=7 Participants	40 participants n=5 Participants
Age, Customized Between 30 and 40 years	25 participants n=5 Participants	24 participants n=7 Participants	49 participants n=5 Participants
Age, Customized > 40 years	24 participants n=5 Participants	24 participants n=7 Participants	48 participants n=5 Participants
Sex: Female, Male Female	43 Participants n=5 Participants	36 Participants n=7 Participants	79 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	33 Participants n=7 Participants	58 Participants n=5 Participants

PRIMARY outcome

Timeframe: Month 6

Population: Modified Intent-to-Treat (mITT). The mITT population included all randomized and treated patients with a study eye having a corneal sensitivity measurement of \< 25 mm in the 3 central regions of the eye on Day 2.

Percentage of patients with clinical success at month 6. Clinical success is defined as the percentage of patients with corneal sensitivity (the capability of the cornea to respond to stimulation) \>= 50 millimeters in all regions of the study eye at month 6 of the Treatment Phase.

Outcome measures

Outcome measures
Measure	RESTASIS® n=42 Participants Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)	REFRESH ENDURA® n=43 Participants Artificial Tears (REFRESH ENDURA®)
Percentage of Patients With Clinical Success at Month 6	64.3 Percentage of Patients	58.1 Percentage of Patients

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: Intent-to-Treat (ITT). The ITT population includes all patients who started the study (randomized).

Change from baseline in keratocyte (specialized cells in the cornea activated after injury or inflammation) density (thickness) in the anterior flap of the eyes (better eye and worse eye) at month 6 of the Treatment Phase. A positive number change from baseline represents an increase in density (improvement). A negative number change from baseline represents a decrease in density (worsening).

Outcome measures

Outcome measures
Measure	RESTASIS® n=68 Participants Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)	REFRESH ENDURA® n=69 Participants Artificial Tears (REFRESH ENDURA®)
Change From Baseline in Keratocyte Density in the Anterior Flap of the Eyes at Month 6 Better Eye: Baseline	28095.7 Cells per cubic millimeter (cells/mm^3) Standard Deviation 5303.28	26069.5 Cells per cubic millimeter (cells/mm^3) Standard Deviation 4648.48
Change From Baseline in Keratocyte Density in the Anterior Flap of the Eyes at Month 6 Better Eye: Change from Baseline at Month 6	901.6 Cells per cubic millimeter (cells/mm^3) Standard Deviation 6117.69	1346.6 Cells per cubic millimeter (cells/mm^3) Standard Deviation 5550.24
Change From Baseline in Keratocyte Density in the Anterior Flap of the Eyes at Month 6 Worse Eye: Baseline	26489.9 Cells per cubic millimeter (cells/mm^3) Standard Deviation 5161.53	27480.6 Cells per cubic millimeter (cells/mm^3) Standard Deviation 4854.00
Change From Baseline in Keratocyte Density in the Anterior Flap of the Eyes at Month 6 Worse Eye: Change from Baseline at Month 6	3011.7 Cells per cubic millimeter (cells/mm^3) Standard Deviation 7931.29	-218.4 Cells per cubic millimeter (cells/mm^3) Standard Deviation 5799.30

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: Intent-to-Treat (ITT). The ITT population includes all patients who started the study (randomized).

Change from baseline in goblet cell density of the eyes (better eye and worse eye) at month 6 of the Treatment Phase. Goblet cells are special cells in the eye that support a healthy tear film. A positive number change from baseline represents an increase in goblet cells (improvement).

Outcome measures

Outcome measures
Measure	RESTASIS® n=68 Participants Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)	REFRESH ENDURA® n=69 Participants Artificial Tears (REFRESH ENDURA®)
Change From Baseline in Goblet Cell Density of the Eyes at Month 6 Better Eye: Baseline	60.9 Cells per square millimeter (cells/mm^2) Interval 0.0 to 291.0	59.7 Cells per square millimeter (cells/mm^2) Interval 0.0 to 193.0
Change From Baseline in Goblet Cell Density of the Eyes at Month 6 Better Eye: Change from Baseline at Month 6	30.9 Cells per square millimeter (cells/mm^2) Interval -284.0 to 115.0	-3.1 Cells per square millimeter (cells/mm^2) Interval -145.0 to 222.0
Change From Baseline in Goblet Cell Density of the Eyes at Month 6 Worse Eye: Change from Baseline at Month 6	15.4 Cells per square millimeter (cells/mm^2) Interval -96.0 to 222.0	9.9 Cells per square millimeter (cells/mm^2) Interval -175.0 to 208.0
Change From Baseline in Goblet Cell Density of the Eyes at Month 6 Worse Eye: Baseline	68.4 Cells per square millimeter (cells/mm^2) Interval 0.0 to 276.0	79.2 Cells per square millimeter (cells/mm^2) Interval 2.0 to 237.0

Adverse Events

RESTASIS®

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

REFRESH ENDURA®

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	RESTASIS® n=68 participants at risk Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)	REFRESH ENDURA® n=69 participants at risk Artificial Tears (REFRESH ENDURA®)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer stage IV	1.5% 1/68	0.00% 0/69
Infections and infestations Infected bites	0.00% 0/68	1.4% 1/69

Other adverse events

Other adverse events
Measure	RESTASIS® n=68 participants at risk Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)	REFRESH ENDURA® n=69 participants at risk Artificial Tears (REFRESH ENDURA®)
Immune system disorders Seasonal allergy	14.7% 10/68	5.8% 4/69
Infections and infestations Upper respiratory tract infection	8.8% 6/68	5.8% 4/69

Additional Information

Therapeutic Area Head

Allergan, Inc.

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo
Publication restrictions are in place

Restriction type: OTHER