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OpenTrials
Completed

NCT Number: NCT00469573

Safety and Efficacy of Optive in Contact Lens Wearers With Dry Eyes

The purpose of this study is to determine if Optive®eye drops are safe for people who wear contact lenses and have dry eyes. The second goal of the study is to determine if using Optive®eye drops can improve my dry eye scores on a standard dry eye test (called the OSDI).

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

South Shore Eye Care

Wantagh, New York, 11793, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women 18 and over
  • Self-reported use of daily-wear soft contact lenses that have been a proper fit for at least one month prior to the screening visit.
  • Complaint of dry eyes
  • OSDI score > 23

Exclusion criteria

  • Use of RGP or PMMA contact lenses
  • Poorly fitting contact lenses
  • Concurrent ocular conditions or pathology that could affect contact lens fit or patient's ability to complete study
  • Concurrent use of topical medications other than study medications
  • Use of systemic medications with ocular drying sequelae:
  • Antihistamines
  • Decongestants
  • Antispasmotics Antidepressants Change in contact lens care solutions within the prior 30 days

Treatment and study plan

1. Optive

Drug

Optive 15ml- (in the eye) Instill one drop twice daily in each eye

Primary outcomes

  1. Safety

    Time frame: 8 months

Secondary outcomes

  1. Efficacy

    Time frame: 8 months

Sponsors and collaborators

Lead sponsor

Innovative Medical

Industry

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 4, 2007
Registry last updated
Apr 1, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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