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NCT01105624

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)

Completed Phase 4 Last updated 20 September 2011
What this trial tests

Phase 4 trial testing azithromycin ophthalmic solution, 1% in Contact Lens Dry Eye in 50 participants. Completed in 1 November 2010.

Timeline
1 March 2010
Primary endpoint
1 November 2010
1 November 2010

Quick facts

Lead sponsorMerck Sharp & Dohme LLC
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment50
Start date1 March 2010
Primary completion1 November 2010
Estimated completion1 November 2010
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

18 and older, any sex, with Contact Lens Dry Eye. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Safety and efficacy of topical azithromycin ophthalmic solution 1.0% in the treatment of contact lens-related dry eye.
    Nichols JJ, Bickle KM, Zink RC, Schiewe MD, et al · · 2012 · cited 24× · PMID 22157392 · DOI 10.1097/icl.0b013e31823ff229
  2. Delivering macrolide antibiotics to heal a broken heart - And other inflammatory conditions.
    Venditto VJ, Feola DJ. · · 2022 · cited 10× · PMID 35367307 · DOI 10.1016/j.addr.2022.114252
  3. Lubricating drops for contact lens discomfort in adults.
    Caffery B, Pucker AD, Chidi-Egboka NC, Obinwanne CJ, et al · · 2024 · cited 3× · PMID 39234924 · DOI 10.1002/14651858.cd015751.pub2

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Trials by the same sponsor.

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Data sources for this page

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