Safety and Acceptability of Using a Rewetting Drop With Contact Lens Wear

Ametropia Clinical Trial

Official title:

Safety and Acceptability of Using a Rewetting Drop With Contact Lens Wear

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00691197
• Other study ID #: AG9689-002
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 4, 2008
• Last updated: June 26, 2015
• Start date: March 2008
• Est. completion date: October 2008

Study information

• Verified date: June 2015
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Testing the Safety and Acceptability of Using a Rewetting Drop with Contact Lenses

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adapted contact lens wearer

Exclusion Criteria:

• Monovision lens wearer, ocular or systemic disease, pregnant or planning to become pregnant

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ametropia

Intervention

Device:
• Carboxymethylcellulose sodium and Glycerin
Eye drops used at least 4 times per day, 1-2 drops in each eye while wearing contact lenses.
• Carboxymethylcellulose sodium
Eye drops used at least 4 times per day, 1-2 drops in each eye while wearing contact lenses.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best Corrected Visual Acuity	Percentage of Subjects Tabulated by Changes in Line Number at Day 90 from Baseline; Visual Acuity measured by LogMar reported as Snellen equivalents. Better: an increase of 2 lines or more in at least one eye; No Change: a change less than +/- 2 lines in both eyes; Worse: a decrease of 2 lines or more in at least one eye.	Change from Baseline at Day 90	No
Secondary	Corneal Staining	Corneal staining of greater or equal to grade 2 at day 90. Grading scale: 0 = None Present; 1 = Trace Finding; 2 = Mild Finding; 3 = Moderate Finding; 4 = Severe Finding	Day 90	No