Trial Outcomes & Findings for Efficacy Study of Cyclosporine Ophthalmic Emulsion in Patients With Dry Eye Disease (NCT NCT00717418)

Results Overview

The OSDI consists of 12 questions to assess visual function, ocular symptoms and environmental triggers related to dry eye. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4 = all of the time) which is converted to a total score between 0-100. OSDI total scores of 0-12=normal (best), 13-22= mild ocular surface disease, 23-32 =moderate ocular surface disease, and 33-100=severe ocular surface disease (worst).

Recruitment status

COMPLETED

Target enrollment

781 participants

Primary outcome timeframe

Baseline

Results posted on

2012-01-12

Participant Flow

Treatment for this study was per normal clinical practice and not assigned.

Participant milestones

Participant milestones
Measure	Restasis® Alone cyclosporine ophthalmic emulsion 0.05%	Artificial Tears Alone	Combination Treatments	Missing Treatment Information
Baseline STARTED	180	74	508	19
Baseline COMPLETED	180	74	508	4
Baseline NOT COMPLETED	0	0	0	15
1-Year Follow-Up STARTED	180	74	508	4
1-Year Follow-Up COMPLETED	33	23	74	0
1-Year Follow-Up NOT COMPLETED	147	51	434	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy Study of Cyclosporine Ophthalmic Emulsion in Patients With Dry Eye Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Restasis® Alone n=180 Participants cyclosporine ophthalmic emulsion 0.05%	Artificial Tears Alone n=74 Participants	Combination Treatments n=508 Participants	Missing Treatment Information n=19 Participants	Total n=781 Participants Total of all reporting groups
Age Continuous	55.0 years n=93 Participants	64.5 years n=4 Participants	60.0 years n=27 Participants	61.0 years n=483 Participants	60.0 years n=36 Participants
Sex: Female, Male Female	125 Participants n=93 Participants	62 Participants n=4 Participants	425 Participants n=27 Participants	15 Participants n=483 Participants	627 Participants n=36 Participants
Sex: Female, Male Male	55 Participants n=93 Participants	12 Participants n=4 Participants	83 Participants n=27 Participants	4 Participants n=483 Participants	154 Participants n=36 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Intent-to-treat, which included all patients who started the study (completed baseline visit) and were assessed for this outcome measure. 16 subjects did not complete this outcome measure assessment and were not included in the analysis.

The OSDI consists of 12 questions to assess visual function, ocular symptoms and environmental triggers related to dry eye. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4 = all of the time) which is converted to a total score between 0-100. OSDI total scores of 0-12=normal (best), 13-22= mild ocular surface disease, 23-32 =moderate ocular surface disease, and 33-100=severe ocular surface disease (worst).

Outcome measures

Outcome measures
Measure	All Patients n=750 Participants
Ocular Surface Disease Index (OSDI) Total Score at Baseline	40.3 Scores on a Scale Standard Deviation 22.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: Intent-to-treat, which included all patients who started the study (completed baseline visit).

Schirmer's Test with and without anesthesia at baseline. The Schirmer's test is performed on each eye with and without anesthesia (numbing eye drop). The amount of wetting produced by the eye was measured in millimeters using a graduated paper scale. The results indicate the presence of dry eye (Normal = greater than or equal to 15 millimeters (mm), Dry eye = less than 15 mm). A larger number correlates to better tear production, a smaller number correlates to reduced tear production.

Outcome measures

Outcome measures
Measure	All Patients n=766 Participants
Schirmer's Test With and Without Anesthesia at Baseline Schirmer's Test with Anesthesia	8.1 millimeters (mm) Standard Deviation 6.3
Schirmer's Test With and Without Anesthesia at Baseline Schirmer's Test without Anesthesia	9.6 millimeters (mm) Standard Deviation 7.9

Adverse Events

All Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Vice President, GHOSR

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