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OpenTrials
Completed

NCT Number: NCT05888519

Evaluation of Safety and Tolerability of Investigational Ocular Lubricants

The purpose of this study is to evaluate investigational ocular lubricants for their safety and tolerability on subjects with mild to moderate dry eye disease.

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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

George Street Eye Centre, Sydney, New South Wales, Australia

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About this study

Subjects will be expected to attend a screening visit followed by 6 additional study visits. The expected duration of subject participation is approximately 3 weeks. This study will be conducted in Australia.

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • Sign an Informed Consent;
  • Have dry eye symptoms;
  • Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

  • Ocular abnormalities;
  • Active ocular infection or inflammation not associated with dry eye;
  • History of ocular or intraocular surgery;
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

FID123300 ocular lubricant

Other

Investigational ocular lubricant

FID123301 ocular lubricant

Other

Investigational ocular lubricant

FID122505 ocular lubricant

Other

Comparator ocular lubricant

Primary outcomes

  1. Best corrected visual acuity (BCVA) with manifest refraction, at distance

    Time frame: Day 1, each wear period. A wear period is 1 day.

    BCVA will be collected for each eye individually and recorded in logarithm Minimum Angle of Resolution (logMAR)

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 5, 2023
Registry last updated
Oct 11, 2023

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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