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

• Sponsor: Innovative Medical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00469573
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arm: 1
• Duration (Months): 10
• Patients Per Site Per Month: 3.6

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Dry Eye	Drug: 1. Optive	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Official Title: Safety and Efficacy of Optive in Contact Lens Wearers With Dry Eyes
• Study Start Date: May 1, 2007
• Actual Primary Completion Date: Mar 1, 2008
• Actual Study Completion Date: Mar 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Other: 1.	Drug: 1. Optive; Optive 15ml- (in the eye) Instill one drop twice daily in each eye

Outcome Measures

Primary Outcome Measures

1. Safety [8 months]

Secondary Outcome Measures

1. Efficacy [8 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	South Shore Eye Care	Wantagh	New York	United States	11793

Sponsors and Collaborators

• Innovative Medical

Investigators

• Principal Investigator: Jodi Luchs, MD, South Shore Eye Care

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00469573
• Other Study ID Numbers: 5302
• First Posted: May 4, 2007
• Last Update Posted: Apr 1, 2008
• Last Verified: Mar 1, 2008

• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca

Study Results

No Results Posted as of Apr 1, 2008