Safety and Efficacy of Cyclosporine Ophthalmic Emulsion in Patients With Primary Pterygium

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01109056
• Collaborator: (none)
• Enrollment: 115
• Locations: 3
• Arms: 2
• Duration (Months): 12
• Patients Per Site: 38.3
• Patients Per Site Per Month: 3.2

Study Details

Study Description

Brief Summary

This study will evaluate the safety and efficacy of Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®) in patients with primary pterygium (abnormal growth on surface of eye).

Condition or Disease	Intervention/Treatment	Phase
Pterygium	Drug: cyclosporine ophthalmic emulsion 0.05%; Drug: Vehicle	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 115 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: Jun 1, 2010
• Actual Primary Completion Date: May 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: cyclosporine ophthalmic emulsion 0.05% One drop in the study eye (or eyes) administered four times daily (QID)	Drug: cyclosporine ophthalmic emulsion 0.05%; One drop in the study eye (or eyes) administered four times daily (QID); Other Names: RESTASIS®
Placebo Comparator: Vehicle One drop in the study eye (or eyes) administered four times daily (QID)	Drug: Vehicle; One drop in the study eye (or eyes) administered four times daily (QID)

Outcome Measures

Primary Outcome Measures

1. Number of Pterygium Hyperemia Responders at Week 16 [Week 16]

   Number of pterygium hyperemia responders at Week 16 as measured by the Pterygium Hyperemia Grading Scale. The Pterygium Hyperemia Grading Scale is a 6-point scale (0=absent, 1=trace, 2=mild, 3=moderate, 4=moderately severe, 5=severe). A responder is defined as a patient demonstrating at least a 2-grade decrease from baseline in pterygium hyperemia.

2. Change From Baseline in Severity Grade of Pterygium Hyperemia at Week 16 [Baseline, Week 16]

   Change from Baseline in Severity Grade of Pterygium Hyperemia at Week 16. The Pterygium Hyperemia Grading Scale is a 6-point scale (0=absent, 1=trace, 2=mild, 3=moderate, 4=moderately severe, 5=severe). A negative number change from baseline is an improvement and a positive number change from baseline is a worsening.

Secondary Outcome Measures

1. Change From Baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire Score at Week 16 [Baseline, Week 16]

   Change from baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire score at Week 16. The OSDI© is a 12-question survey for patients to document their dry eye disease symptoms. Each question is rated on a 5-point scale (0=none of the time and 4 = all of the time). The scores are totaled over the 12 questions and normalized/converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Have a pterygium in at least one eye that has not been previously removed with surgery

Exclusion Criteria:

• Uncontrolled systemic disease

• Active eye disease

• Current or anticipated use of topical eye medications other than artificial tears.

• Anticipated wearing of contact lenses

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Glendale	California	United States
2		Randwick	New South Wales	Australia
3		Singapore		Singapore

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: NCT01109056
• Other Study ID Numbers: 192371-019
• First Posted: Apr 22, 2010
• Last Update Posted: Jun 25, 2012
• Last Verified: May 1, 2012

• Additional relevant MeSH terms: Pterygium; Cyclosporine; Cyclosporins

Study Results

Participant Flow

Arm/Group Title	Cyclosporine Ophthalmic Emulsion 0.05%	Vehicle
Arm/Group Description	One drop in the study eye (or eyes) administered four times daily (QID)	One drop in the study eye (or eyes) administered four times daily (QID)
Period Title: Overall Study
STARTED	57	58
COMPLETED	50	53
NOT COMPLETED	7	5

Baseline Characteristics

Arm/Group Title	Cyclosporine Ophthalmic Emulsion 0.05%	Vehicle	Total
Arm/Group Description	One drop in the study eye (or eyes) administered four times daily (QID)	One drop in the study eye (or eyes) administered four times daily (QID)	Total of all reporting groups
Overall Participants	57	58	115
Age, Customized (Number) [Number]
<45 years	13 22.8%	15 25.9%	28 24.3%
Between 45 and 65 years	36 63.2%	36 62.1%	72 62.6%
>65 years	8 14%	7 12.1%	15 13%
Sex: Female, Male (Count of Participants)
Female	16 28.1%	23 39.7%	39 33.9%
Male	41 71.9%	35 60.3%	76 66.1%

Outcome Measures

1. Primary Outcome

Title	Number of Pterygium Hyperemia Responders at Week 16
Description	Number of pterygium hyperemia responders at Week 16 as measured by the Pterygium Hyperemia Grading Scale. The Pterygium Hyperemia Grading Scale is a 6-point scale (0=absent, 1=trace, 2=mild, 3=moderate, 4=moderately severe, 5=severe). A responder is defined as a patient demonstrating at least a 2-grade decrease from baseline in pterygium hyperemia.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

Modified Intent to Treat: All randomized patients who received study treatment and had a baseline and at least one post-baseline assessment of pterygium hyperemia

Arm/Group Title	Cyclosporine Ophthalmic Emulsion 0.05%	Vehicle
Arm/Group Description	One drop in the study eye (or eyes) administered four times daily (QID)	One drop in the study eye (or eyes) administered four times daily (QID)
Measure Participants	56	57
Number [Participants]	6 10.5%	8 13.8%

2. Primary Outcome

Title	Change From Baseline in Severity Grade of Pterygium Hyperemia at Week 16
Description	Change from Baseline in Severity Grade of Pterygium Hyperemia at Week 16. The Pterygium Hyperemia Grading Scale is a 6-point scale (0=absent, 1=trace, 2=mild, 3=moderate, 4=moderately severe, 5=severe). A negative number change from baseline is an improvement and a positive number change from baseline is a worsening.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

Modified Intent to Treat: All randomized patients who received study treatment and had a baseline and at least one post-baseline assessment of pterygium hyperemia

Arm/Group Title	Cyclosporine Ophthalmic Emulsion 0.05%	Vehicle
Arm/Group Description	One drop in the study eye (or eyes) administered four times daily (QID)	One drop in the study eye (or eyes) administered four times daily (QID)
Measure Participants	56	57
Baseline	3.1 (0.35)	3.2 (0.37)
Change from Baseline at Week 16	-0.7 (0.76)	-0.8 (0.75)

3. Secondary Outcome

Title	Change From Baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire Score at Week 16
Description	Change from baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire score at Week 16. The OSDI© is a 12-question survey for patients to document their dry eye disease symptoms. Each question is rated on a 5-point scale (0=none of the time and 4 = all of the time). The scores are totaled over the 12 questions and normalized/converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

Modified Intent to Treat: All randomized patients who received study treatment and had a baseline and at least one post-baseline assessment of pterygium hyperemia

Arm/Group Title	Cyclosporine Ophthalmic Emulsion 0.05%	Vehicle
Arm/Group Description	One drop in the study eye (or eyes) administered four times daily (QID)	One drop in the study eye (or eyes) administered four times daily (QID)
Measure Participants	56	57
Baseline	20.2 (16.97)	29.3 (26.89)
Change from Baseline at Week 16	-3.1 (14.95)	-10.5 (16.02)

Adverse Events

Adverse Event Reporting Description	The Safety Population was used to calculate the number of participants at risk for SAEs and AEs, and is defined as all randomized and treated patients.
Arm/Group Title	Cyclosporine Ophthalmic Emulsion 0.05%		Vehicle
Arm/Group Description	One drop in the study eye (or eyes) administered four times daily (QID)		One drop in the study eye (or eyes) administered four times daily (QID)
All Cause Mortality
	Cyclosporine Ophthalmic Emulsion 0.05%		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Cyclosporine Ophthalmic Emulsion 0.05%		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/56 (1.8%)		1/58 (1.7%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma	1/16 (6.3%)		0/23 (0%)
Meningioma benign	0/56 (0%)		1/58 (1.7%)
Other (Not Including Serious) Adverse Events
	Cyclosporine Ophthalmic Emulsion 0.05%		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	19/56 (33.9%)		16/58 (27.6%)
Eye disorders
Eye Irritation	4/56 (7.1%)		3/58 (5.2%)
Conjunctival hyperaemia	4/56 (7.1%)		2/58 (3.4%)
Eye Pain	3/56 (5.4%)		2/58 (3.4%)
Lacrimation Increased	3/56 (5.4%)		0/58 (0%)
General disorders
Instillation Site Pain	3/56 (5.4%)		2/58 (3.4%)
Infections and infestations
Upper Respiratory Tract Infection	1/56 (1.8%)		7/58 (12.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Adenoma	1/16 (6.3%)		0/23 (0%)

Limitations/Caveats

[Not Specified]

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.