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

Phase 4

Completed

• Conditions: Dry Eye
• Interventions: Drug: Systane, Optive, Restasis

• Registration Number: NCT00399061
• Lead Sponsor: Innovative Medical

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2006-11-09
• Study First Submitted QC: 2006-11-09
• Study First Posted: 2006-11-14
• Status Verified: 2008-09
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Last Update Submitted: 2008-09-23
• Last Update Posted: 2008-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Systane, Optive, Restasis	Systane
2	Systane, Optive, Restasis	Optive
3	Systane, Optive, Restasis	Restasis

Primary Outcome Measures

Name	Time	Method
Efficacy	1 yr 3 months

Secondary Outcome Measures

Name	Time	Method
Dry eye symptoms	1yr 3 months

Trial Locations

Locations (1)

Dr. Schultze; 🇺🇸 Slingerlands, New York, United States