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)

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 4

Conditions

Contact Lens Dry Eye

Treatments

Drug: azithromycin ophthalmic solution, 1%

Drug: Visine® for Contacts®

Study type

Interventional

Funder types

Industry

Identifiers

NCT01105624

041-117

P08644

Details and patient eligibility

About

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

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.