Tear Dynamics After Restasis Treatment in Dry Eye Patients

Dry Eye Clinical Trial

Official title:

Tear Dynamics After Restasis Treatment in Dry Eye Patients Phase II Clinical Trial and Phase IIb 6-month Follow-up After Discontinuation of Study Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00706940
• Other study ID #: 20080340
• Status: Completed
• Phase: N/A
• First received: June 26, 2008
• Last updated: April 24, 2017
• Start date: August 2011
• Est. completion date: December 31, 2016

Study information

• Verified date: April 2017
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Observe the changes of tear volume in dry eye patients after Restasis treatment of 3 months and during 6-month follow-up after discontinuation of study treatment.

Description:

Using an imaging device name optical coherence tomography to image the tear volume in dry eye patients before and after Restasis treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

The participant will be eligible for entry in the study if s/he:

1. Is at least 18 years old and has full legal capacity to volunteer;

2. Has read and signed the IRB Informed Consent Document;

3. Is willing and able to follow participant instructions;

4. Has clear corneas;

5. Has 20/100 uncorrected visual acuity or better;

6. Has dry eye according to the study definition of DES (study subjects);

7. Has not use Restasis within 3 months.

Exclusion Criteria:

The subjects will ineligible for entry into the study if s/he:

1. Has any systemic disease affecting ocular health except for Sjögren's syndrome;

2. Is using any systemic or topical medications that will affect ocular health except for artificial tears;

3. Has an active ocular disease other than DES, or Sjögren's syndrome

4. Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities;

5. Has limbal or bulbar injection or corneal staining that was clinically significant, which are not due to DES;

6. Has worn rigid gas permeable lenses within 1 year and during the study;

7. Has had surgery or an eye injury within 6 months;

8. Was a soft contact lens wearer within 2 weeks and during the study.

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Locations

Country	Name	City	State
United States	Bascom Palmer Eye Institute	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in tear volume after the 3-month treatment and returned to baseline during 6-month follow-up after discontinuation of study treatment.		3 months for treatment and follow-up of 6 months after discontinuation of study treatment.
Primary	Tear meniscus volume after treatment	Significant increase in tear meniscus volume was found in patients after 3 months of treatment.	3 months