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

NCT00399061 | Completed Phase 4

• 1 other identifier: 5278
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• Efficacy

  1 yr 3 months

Secondary Outcomes (1)

• Dry eye symptoms

  1yr 3 months

Study Arms (3)

1

ACTIVE COMPARATOR

Systane

Drug: Systane, Optive, Restasis

2

ACTIVE COMPARATOR

Optive

Drug: Systane, Optive, Restasis

3

PLACEBO COMPARATOR

Restasis

Drug: Systane, Optive, Restasis

Interventions

Systane, Optive, Restasis DRUG

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

1; 2; 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• · 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

You may not qualify if:

• · 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

Sponsors & Collaborators

• Innovative Medical: lead

Study Sites (1)

Dr. Schultze

Slingerlands, New York, 12159, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Cyclosporins

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Robert Schultze, MD

  Slingerlands Medical Building

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 9, 2006
• First Posted: November 14, 2006
• Study Start: November 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: September 25, 2008

Record last verified: 2008-09

Locations

US (1)