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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) logo

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

azithromycin ophthalmic solution, 1%
Experimental group
Treatment:
Drug: azithromycin ophthalmic solution, 1%
rewetting drops
Experimental group
Treatment:
Drug: Visine® for Contacts®

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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