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

NCT01109056 | Completed Phase 2 Results

• 1 other identifier: 192371-019
• Study Type: interventional
• Target: 115
• Locations: 3 countries
• Sites: 3

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).

Conditions

Pterygium

Outcome Measures

Primary Outcomes (2)

• Number of Pterygium Hyperemia Responders at 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.

  Week 16

• Change From Baseline in Severity Grade of Pterygium Hyperemia at 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.

  Baseline, Week 16

Secondary Outcomes (1)

• Change From Baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire Score at Week 16

  Baseline, Week 16

Study Arms (2)

cyclosporine ophthalmic emulsion 0.05%

EXPERIMENTAL

One drop in the study eye (or eyes) administered four times daily (QID)

Drug: cyclosporine ophthalmic emulsion 0.05%

Vehicle

PLACEBO COMPARATOR

One drop in the study eye (or eyes) administered four times daily (QID)

Drug: Vehicle

Interventions

cyclosporine ophthalmic emulsion 0.05% DRUG

One drop in the study eye (or eyes) administered four times daily (QID)

Also known as: RESTASIS®

cyclosporine ophthalmic emulsion 0.05%

Vehicle DRUG

One drop in the study eye (or eyes) administered four times daily (QID)

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Uncontrolled systemic disease
• Active eye disease
• Current or anticipated use of topical eye medications other than artificial tears.
• Anticipated wearing of contact lenses

Sponsors & Collaborators

• Allergan: lead

Study Sites (3)

Unknown Facility

Glendale, California, United States

Location

Unknown Facility

Randwick, New South Wales, Australia

Location

Unknown Facility

Singapore, Singapore

Location

MeSH Terms

Conditions

Pterygium

Interventions

Cyclosporins

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Therapeutic Area Head,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2010
• First Posted: April 22, 2010
• Study Start: June 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: June 1, 2011
• Last Updated: June 25, 2012
• Results First Posted: June 25, 2012

Record last verified: 2012-05

Locations

US (1); SG (1); AU (1)