Oasys vs. Extreme H20 Xtra 59

• Sponsor: Innovative Medical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00477763
• Collaborator: (none)
• Enrollment: 52
• Location: 1
• Arms: 2
• Duration (Months): 9.1
• Patients Per Site Per Month: 5.7

Study Details

Study Description

Brief Summary

To compare the performance of Oasys to Extreme H20 xtra 59 in dry eye contact lens pts who receive Restasis in 1 eye and vehicle (Endura) in the other eye.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye	Drug: Restasis, Refresh Endura	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Official Title: Oasys vs. Extreme H20 Xtra 59
• Study Start Date: May 1, 2007
• Actual Primary Completion Date: Feb 1, 2008
• Actual Study Completion Date: Feb 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1	Drug: Restasis, Refresh Endura; Restasis 0.4ml- (in the eye) instill twice daily in the randomized eye morning and evening Refresh Endura 0.4ml- (in the eye) instill twice daily in the randomized eye morning and evening
Placebo Comparator: 2	Drug: Restasis, Refresh Endura; Restasis 0.4ml- (in the eye) instill twice daily in the randomized eye morning and evening Refresh Endura 0.4ml- (in the eye) instill twice daily in the randomized eye morning and evening

Outcome Measures

Primary Outcome Measures

1. comparing performance of contact lens [10 months]

Secondary Outcome Measures

1. Dry eye [10 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or Female at least 19 years of age

• Contact Lens Wearers

• Patients with mild to moderate symptoms of dry eye

Exclusion Criteria:

• male or female younger than 19 years of age

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hazleton Eye Specialists	Hazleton	Pennsylvania	United States	18202

Sponsors and Collaborators

• Innovative Medical

Investigators

• Principal Investigator: Thomas Kislan, OD, Hazleton Eye Specialists

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00477763
• Other Study ID Numbers: 5300
• First Posted: May 24, 2007
• Last Update Posted: Feb 18, 2008
• Last Verified: Feb 1, 2008

• Additional relevant MeSH terms: Dry Eye Syndromes; Cyclosporine; Cyclosporins

Study Results

No Results Posted as of Feb 18, 2008