Safety and Efficacy of Optive in Contact Lens Wearers With Dry Eyes

Dry Eye Clinical Trial

Official title:

Safety and Efficacy of Optive in Contact Lens Wearers With Dry Eyes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00469573
• Other study ID #: 5302
• Status: Completed
• Phase: Phase 4
• First received: May 2, 2007
• Last updated: March 31, 2008
• Start date: May 2007
• Est. completion date: March 2008

Study information

• Verified date: March 2008
• Source: Innovative Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if Optive®eye drops are safe for people who wear contact lenses and have dry eyes. The second goal of the study is to determine if using Optive®eye drops can improve my dry eye scores on a standard dry eye test (called the OSDI).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men and women 18 and over

• Self-reported use of daily-wear soft contact lenses that have been a proper fit for at least one month prior to the screening visit.

• Complaint of dry eyes

• OSDI score > 23

Exclusion Criteria:

• Use of RGP or PMMA contact lenses

• Poorly fitting contact lenses

• Concurrent ocular conditions or pathology that could affect contact lens fit or patient's ability to complete study

• Concurrent use of topical medications other than study medications

• Use of systemic medications with ocular drying sequelae:

• Antihistamines

• Decongestants

• Antispasmotics Antidepressants Change in contact lens care solutions within the prior 30 days

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• 1. Optive
Optive 15ml- (in the eye) Instill one drop twice daily in each eye

Locations

Country	Name	City	State
United States	South Shore Eye Care	Wantagh	New York

Sponsors (1)

Lead Sponsor	Collaborator
Innovative Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety		8 months	Yes
Secondary	Efficacy		8 months	Yes