Trial Outcomes & Findings for Safety and Efficacy of Cyclosporine Ophthalmic Emulsion in Patients With Primary Pterygium (NCT NCT01109056)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

115 participants

Primary outcome timeframe

Week 16

Results posted on

2012-06-25

Participant Flow

Participant milestones

Participant milestones
Measure	Cyclosporine Ophthalmic Emulsion 0.05% One drop in the study eye (or eyes) administered four times daily (QID)	Vehicle One drop in the study eye (or eyes) administered four times daily (QID)
Overall Study STARTED	57	58
Overall Study COMPLETED	50	53
Overall Study NOT COMPLETED	7	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cyclosporine Ophthalmic Emulsion 0.05% n=57 Participants One drop in the study eye (or eyes) administered four times daily (QID)	Vehicle n=58 Participants One drop in the study eye (or eyes) administered four times daily (QID)	Total n=115 Participants Total of all reporting groups
Age, Customized <45 years	13 Participants n=5 Participants	15 Participants n=7 Participants	28 Participants n=5 Participants
Age, Customized Between 45 and 65 years	36 Participants n=5 Participants	36 Participants n=7 Participants	72 Participants n=5 Participants
Age, Customized >65 years	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	23 Participants n=7 Participants	39 Participants n=5 Participants
Sex: Female, Male Male	41 Participants n=5 Participants	35 Participants n=7 Participants	76 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 16

Population: 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

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.

Outcome measures

Outcome measures
Measure	Cyclosporine Ophthalmic Emulsion 0.05% n=56 Participants One drop in the study eye (or eyes) administered four times daily (QID)	Vehicle n=57 Participants One drop in the study eye (or eyes) administered four times daily (QID)
Number of Pterygium Hyperemia Responders at Week 16	6 Participants	8 Participants

PRIMARY outcome

Timeframe: Baseline, Week 16

Population: 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

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.

Outcome measures

Outcome measures
Measure	Cyclosporine Ophthalmic Emulsion 0.05% n=56 Participants One drop in the study eye (or eyes) administered four times daily (QID)	Vehicle n=57 Participants One drop in the study eye (or eyes) administered four times daily (QID)
Change From Baseline in Severity Grade of Pterygium Hyperemia at Week 16 Change from Baseline at Week 16	-0.7 Scores on a Scale Standard Deviation 0.76	-0.8 Scores on a Scale Standard Deviation 0.75
Change From Baseline in Severity Grade of Pterygium Hyperemia at Week 16 Baseline	3.1 Scores on a Scale Standard Deviation 0.35	3.2 Scores on a Scale Standard Deviation 0.37

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: 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

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.

Outcome measures

Outcome measures
Measure	Cyclosporine Ophthalmic Emulsion 0.05% n=56 Participants One drop in the study eye (or eyes) administered four times daily (QID)	Vehicle n=57 Participants One drop in the study eye (or eyes) administered four times daily (QID)
Change From Baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire Score at Week 16 Baseline	20.2 Scores on a Scale Standard Deviation 16.97	29.3 Scores on a Scale Standard Deviation 26.89
Change From Baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire Score at Week 16 Change from Baseline at Week 16	-3.1 Scores on a Scale Standard Deviation 14.95	-10.5 Scores on a Scale Standard Deviation 16.02

Adverse Events

Cyclosporine Ophthalmic Emulsion 0.05%

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

Vehicle

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cyclosporine Ophthalmic Emulsion 0.05% n=56 participants at risk One drop in the study eye (or eyes) administered four times daily (QID)	Vehicle n=58 participants at risk One drop in the study eye (or eyes) administered four times daily (QID)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian adenoma	6.2% 1/16 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.	0.00% 0/23 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma benign	0.00% 0/56 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.	1.7% 1/58 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.

Other adverse events

Other adverse events
Measure	Cyclosporine Ophthalmic Emulsion 0.05% n=56 participants at risk One drop in the study eye (or eyes) administered four times daily (QID)	Vehicle n=58 participants at risk One drop in the study eye (or eyes) administered four times daily (QID)
Eye disorders Eye Irritation	7.1% 4/56 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.	5.2% 3/58 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.
Eye disorders Conjunctival hyperaemia	7.1% 4/56 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.	3.4% 2/58 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.
Eye disorders Eye Pain	5.4% 3/56 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.	3.4% 2/58 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.
General disorders Instillation Site Pain	5.4% 3/56 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.	3.4% 2/58 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.
Eye disorders Lacrimation Increased	5.4% 3/56 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.	0.00% 0/58 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.
Infections and infestations Upper Respiratory Tract Infection	1.8% 1/56 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.	12.1% 7/58 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian Adenoma	6.2% 1/16 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.	0.00% 0/23 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.

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