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)

Phase 4

Completed

• Conditions: Contact Lens Dry Eye
• Interventions: Drug: azithromycin ophthalmic solution, 1%; Drug: Visine® for Contacts®

• Registration Number: NCT01105624
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-04-15
• Study First Submitted QC: 2010-04-15
• Study First Posted: 2010-04-16
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Disposition First Submitted: 2011-03-24
• Disposition First Submitted QC: 2011-03-30
• Disposition First Posted: 2011-04-01
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-20
• Last Update Posted: 2011-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
azithromycin ophthalmic solution, 1%	azithromycin ophthalmic solution, 1%	-
rewetting drops	Visine® for Contacts®	-

Primary Outcome Measures

Name	Time	Method
Subject-reported comfortable contact lens daily wear time (hours/day) at Week 4 Endpoint	4 weeks

Secondary Outcome Measures

Name	Time	Method
Subject-reported comfortable contact lens daily wear time, excluding Week 4 Endpoint	2 weeks
Subject-reported duration of total contact lens daily wear	4 weeks
Subject-reported rating of overall eye dryness	4 weeks
Contact Lens-Related Dry Eye Questionnaire	4 weeks
Tear hyperosmolarity (mOsm)	4 weeks
Habitual low-contrast visual acuity (LCVA)	4 weeks

Trial Locations

Locations (1)

The Ohio State University, College of Optometry; 🇺🇸 Columbus, Ohio, United States