Efficacy of Optive Versus Systane Concomitant With Restasis (Cyclosporine A) for the Treatment of Dry Eye Symptoms

Dry Eye Clinical Trial

Official title:

Efficacy of Optive Versus Systane Concomitant With Restasis (Cyclosporine A) for the Treatment of Dry Eye Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00399061
• Other study ID #: 5278
• Status: Completed
• Phase: Phase 4
• First received: November 9, 2006
• Last updated: September 23, 2008
• Start date: November 2006
• Est. completion date: September 2008

Study information

• Verified date: September 2008
• Source: Innovative Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of Optive versus Systane used concomitantly with topical cyclosporine for the treatment of dry eye.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• · Males or females > 18 years old

• Score of at least 2 and no more than 4 on the SESOD at the initial screening visit (mild to severe patients)

• At least Grade 2 conjunctival staining

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

Exclusion Criteria:

• · Prior unsuccessful use of topical cyclosporine (defined as patients taking it at least 3 months and saw no improvements)

• Current use of topical cyclosporine

• 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.

• Planned use of contact lenses (unless discontinued use ³ 30 days prior to randomization)

• Active ocular diseases or uncontrolled systemic disease (blepharitis patients that are actively being treated or disease that is uncontrollable)

• Ocular surgery within the past 3 months,

• Active ocular allergies

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Systane, Optive, Restasis
Systane 30ml (in the eye) instill one drop twice a day in morning and evening Optive 15ml (in the eye) instill one drop twice a day in morning and evening Restasis 0.4ml (in the eye) instill one drop twice a day in morning and evening more frequently if needed

Locations

Country	Name	City	State
United States	Dr. Schultze	Slingerlands	New York

Sponsors (1)

Lead Sponsor	Collaborator
Innovative Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy		1 yr 3 months	No
Secondary	Dry eye symptoms		1yr 3 months	No