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

I

Innovative Medical

Status and phase

Completed
Phase 4

Conditions

Dry Eye

Treatments

Drug: Systane, Optive, Restasis

Study type

Interventional

Funder types

Industry

Identifiers

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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