Efficacy and Safety of a New Multi-dose Lubricant Eye Drop 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: Restasis, Optive Tears

Study type: Interventional

Funder types: Industry

Identifiers

NCT00405457

5261

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

A

Other group

Treatment:

Drug: Restasis, Optive Tears