A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Rewetting Drops in Subjects With History and Current Complaint of Contact Lens-Related Dry Eye (CLDE)

Contact Lens Dry Eye Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01105624
• Other study ID #: 041-117
• Secondary ID: P08644
• Status: Completed
• Phase: Phase 4
• First received: April 15, 2010
• Last updated: September 20, 2011
• Start date: March 2010
• Est. completion date: November 2010

Study information

• Verified date: September 2011
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to compare the duration of subject reported comfortable contact lens daily wear time in subjects with a history and current complaint of CLDE during a 29-day treatment period of azithromycin ophthalmic solution, 1%, compared to rewetting drops

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have a history of and current complaint of CLDE.

• Use properly fitted daily-wear soft contact lenses.

• Able to wear contact lenses for at least 8 hours a day.

• If female, are non-pregnant or non-lactating.

Exclusion Criteria:

• Have changed brand of contact lens or care solutions within one month prior to Visit 1.

• Use extended (overnight) wear contact lenses.

• Have a clinically significant ophthalmic abnormality.

• Have had cauterization of the punctum or have had punctal plugs (silicone or collagen) inserted or removed within the 90 days prior to the screening.

• Have any active ongoing ocular infection or ocular disease.

• Have a serious medical condition which could confound study assessments.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Contact Lens Dry Eye

Intervention

Drug:
• azithromycin ophthalmic solution, 1%
1 drop BID for the first 2 days and then 1 drop QD for the remainder of treatment period (29 ± 1 day)
• Visine® for Contacts®
1-2 drops QID for the treatment period (29 ± 1 day)

Locations

Country	Name	City	State
United States	The Ohio State University, College of Optometry	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject-reported comfortable contact lens daily wear time (hours/day) at Week 4 Endpoint		4 weeks	No
Secondary	Subject-reported comfortable contact lens daily wear time, excluding Week 4 Endpoint		2 weeks	No
Secondary	Subject-reported duration of total contact lens daily wear		4 weeks	No
Secondary	Subject-reported rating of overall eye dryness		4 weeks	No
Secondary	Contact Lens-Related Dry Eye Questionnaire		4 weeks	No
Secondary	Tear hyperosmolarity (mOsm)		4 weeks	No
Secondary	Habitual low-contrast visual acuity (LCVA)		4 weeks	No