Efficacy and Safety of a New Multi-dose Lubricant Eye Drop Concomitant With Restasis® (Cyclosporine A) for the Treatment of Dry Eye Symptoms

• Sponsor: Innovative Medical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00405457
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arm: 1
• Duration (Months): 14
• Patients Per Site Per Month: 3.6

Study Details

Study Description

Brief Summary

To evaluate the efficacy, safety and tolerability of a combination of Optive® Artificial Tears with Restasis®.The primary hypothesis is that the Ocular Surface Disease Index (OSDI) score and symptoms will be the same or lower than baseline after treatment in these patients. The patients will tolerate the combination of Restasis® and Optive® with a low incidence of clinical adverse events.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye	Drug: Restasis, Optive Tears	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of a New Multi-dose Lubricant Eye Drop Concomitant With Restasis® (Cyclosporine A) for the Treatment of Dry Eye Symptoms
• Study Start Date: Nov 1, 2006
• Actual Primary Completion Date: Jan 1, 2008
• Actual Study Completion Date: Jan 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Other: A	Drug: Restasis, Optive Tears; Restasis and Optive Tears use twice daily more frequently if needed

Outcome Measures

Primary Outcome Measures

1. efficacy [1 yr 3 months]

Secondary Outcome Measures

1. dry eye symptoms [1 yr 3 months]

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• · Males or females > 18 years old

• Patients currently taking Restasis® for at least 3 months in duration and using artificial tears as needed for dry eye.

• Likely to complete all study visits and able to provide informed consent

Exclusion Criteria:

• · Patients using Restasis® for less than 3 months.

• Known contraindications to any study medication or ingredients

• Female of child bearing potential not using reliable methods of birth control, or pregnant or lactating females.

• Other active uncontrolled ocular diseases or uncontrolled systemic disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Minnesota Eye Consultants	Minneapolis	Minnesota	United States	55404

Sponsors and Collaborators

• Innovative Medical

Investigators

• Principal Investigator: David Hardten, MD, Minnesota Eye Consultants

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00405457
• Other Study ID Numbers: 5261
• First Posted: Nov 30, 2006
• Last Update Posted: Feb 22, 2010
• Last Verified: Feb 1, 2010

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

Study Results

No Results Posted as of Feb 22, 2010