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

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00717418
• Collaborator: (none)
• Enrollment: 781
• Location: 1
• Duration (Months): 47
• Patients Per Site Per Month: 16.6

Study Details

Study Description

Brief Summary

This study will evaluate the efficacy of cyclosporine ophthalmic solution vs. other non-prescription treatments in patients with dry eye disease. Patient and physician assessments completed at baseline, at each follow-up visit (follow-up visits are variable as per physician discretion) and at final follow-up visit.

Condition or Disease	Intervention/Treatment	Phase
Keratoconjunctivitis Sicca	Drug: cyclosporine ophthalmic emulsion 0.05%, artificial tears

Study Design

• Study Type: Observational
• Actual Enrollment: 781 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Study Start Date: Sep 1, 2004
• Actual Primary Completion Date: Aug 1, 2006
• Actual Study Completion Date: Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
1 cyclosporine ophthalmic emulsion 0.05% artificial tears	Drug: cyclosporine ophthalmic emulsion 0.05%, artificial tears; one drop, twice a day in each eye; Other Names: Restasis®

Outcome Measures

Primary Outcome Measures

1. Ocular Surface Disease Index (OSDI) Total Score at Baseline [Baseline]

   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).

Other Outcome Measures

1. Schirmer's Test With and Without Anesthesia at Baseline [Baseline]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of dry eye disease

• Currently using artificial tears daily

• Male or female of legal age of consent

• Normal lid position and closure

Exclusion Criteria

• Patients currently using cyclosporine ophthalmic emulsion 0.05%

• Participation in other investigational drug or device study

• Any current or previous topical ophthalmic or oral cyclosporine use within the last three years

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Wilson	North Carolina	United States

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Director, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT00717418
• Other Study ID Numbers: R.E.S.T.O.R.E.
• First Posted: Jul 17, 2008
• Last Update Posted: Jan 12, 2012
• Last Verified: Dec 1, 2011

• Additional relevant MeSH terms: Keratoconjunctivitis; Keratoconjunctivitis Sicca; Dry Eye Syndromes; Cyclosporine; Lubricant Eye Drops; Cyclosporins

Study Results

Participant Flow

Pre-assignment Detail	Treatment for this study was per normal clinical practice and not assigned.

Arm/Group Title	Restasis® Alone	Artificial Tears Alone	Combination Treatments	Missing Treatment Information
Arm/Group Description	cyclosporine ophthalmic emulsion 0.05%
Period Title: Baseline
STARTED	180	74	508	19
COMPLETED	180	74	508	4
NOT COMPLETED	0	0	0	15
Period Title: Baseline
STARTED	180	74	508	4
COMPLETED	33	23	74	0
NOT COMPLETED	147	51	434	4

Baseline Characteristics

Arm/Group Title	Restasis® Alone	Artificial Tears Alone	Combination Treatments	Missing Treatment Information	Total
Arm/Group Description	cyclosporine ophthalmic emulsion 0.05%	Total of all reporting groups
Overall Participants	180	74	508	19	781
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	55.0	64.5	60.0	61.0	60.0
Sex: Female, Male (Count of Participants)
Female	125 69.4%	62 83.8%	425 83.7%	15 78.9%	627 80.3%
Male	55 30.6%	12 16.2%	83 16.3%	4 21.1%	154 19.7%

Outcome Measures

1. Primary Outcome

Title	Ocular Surface Disease Index (OSDI) Total Score at Baseline
Description	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).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	All Patients
Arm/Group Description
Measure Participants	750
Mean (Standard Deviation) [Scores on a Scale]	40.3 (22.0)

2. Other Pre-specified Outcome

Title	Schirmer's Test With and Without Anesthesia at Baseline
Description	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.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	All Patients
Arm/Group Description
Measure Participants	766
Schirmer's Test with Anesthesia	8.1 (6.3)
Schirmer's Test without Anesthesia	9.6 (7.9)

Adverse Events

Adverse Event Reporting Description	Serious adverse events and adverse events were not collected/assessed.
Arm/Group Title	All Patients
Arm/Group Description
All Cause Mortality
	All Patients
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	All Patients
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	All Patients
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

Due to actual dry eye treatment used, data were not interpretable by separate treatment arms. Hence, Outcomes are only reported as a single group.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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