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

This study has been completed.

First Received: May 2, 2007 Last Updated: March 31, 2008 History of Changes

Sponsored by:	Innovative Medical
Information provided by:	Innovative Medical
ClinicalTrials.gov Identifier:	NCT00469573

Purpose

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	Intervention	Phase
Dry Eye	Drug: 1. Optive	Phase IV

MedlinePlus related topics: Eye Wear

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Single Group Assignment
Official Title:	Safety and Efficacy of Optive in Contact Lens Wearers With Dry Eyes

Further study details as provided by Innovative Medical:

Primary Outcome Measures:

Safety [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Efficacy [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]

Enrollment:	36
Study Start Date:	May 2007
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00469573

Locations

United States, New York
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

More Information

No publications provided

Responsible Party:	South Shore Eye Care ( Jodi Luchs, MD )
Study ID Numbers:	5302
Study First Received:	May 2, 2007
Last Updated:	March 31, 2008
ClinicalTrials.gov Identifier:	NCT00469573 History of Changes
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 06, 2009