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

Innovative Medical

Status and phase: Completed; Phase 4

Conditions: Dry Eye

Treatments: Drug: Systane, Optive, Restasis

Study type: Interventional

Funder types: Industry

Identifiers

NCT00399061

5278

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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55 participants in 3 patient groups, including a placebo group

1

Active Comparator group

Description:

Systane

Treatment:

Drug: Systane, Optive, Restasis

2

Active Comparator group

Description:

Optive

Treatment:

Drug: Systane, Optive, Restasis

3

Placebo Comparator group

Description:

Restasis

Treatment:

Drug: Systane, Optive, Restasis