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)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01105624

Enrollment

Registered

2010-04-16

Start date

2010-03-31

Completion date

2010-11-30

Last updated

2011-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contact Lens Dry Eye

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

Interventions

DRUGazithromycin 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)

DRUGVisine® for Contacts®

1-2 drops QID for the treatment period (29 ± 1 day)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026