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OpenTrials
Completed

NCT Number: NCT03208673

Optive Brand For Day And Night Dry Eye Management

This is an open label study of Optive eyedrops and gel combination for day and night dry eye management

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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

Not applicable

Primary location

Ocular Technology Group - international

London, SW1E 6AU, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • OSDI score of ≥ 23
  • Ocular comfort at waking <65 on 100-point scale
  • Conjunctival staining Grade ≥ 2 (scale 0 to 4) in at least one eye
  • Use of eyedrops for the relief of dry eye symptoms for at least one month
  • Best corrected visual acuity in each eye of at least 20/25
  • Have normal eyes with the exception of the need for visual correction; subjects must be willing to cease contact lens wear for the duration of the study
  • Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule

Exclusion criteria

  • Use of Benzalkonium Chloride (BAK) preserved eyedrops in the last month
  • Use of Optive brand eyedrops in the last month
  • Monocular participants (only one eye with functional vision).
  • Contact lens wear during the study
  • History of herpetic keratitis, ocular surgery or irregular cornea;
  • Known pregnancy or lactation during the study period
  • Participation in any clinical trial within 30 days of the enrollment visit

Treatment and study plan

Optive® Fusion + Optive® Gel Drop

Device

Optive® Fusion eyedrop will be used as needed up to four times a day but at least twice a day. The eyedrop will be used once in the evening; the gel drop being instilled any time during the last hour prior to sleep.

Primary outcomes

  1. Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score

    Time frame: Change from baseline to (day 30 +/- 3 days)

    A 12-question survey used to measure the symptoms of dry eye disease. Each of the 12 individual questions rate one symptom on a 0-4 scale, with 4 meaning that the symptom is present all of the time and 0 meaning the symptom is present none of the time. The overall ODSI score is calculated by adding all of the values from the 12 questions, multiplying that value by 25, and dividing the resulting value by the number of questions answered. This results in an overall scale that ranges from 0-100, with 100 being severe dry eye symptoms and 0 being no dry eye symptoms.

  2. Measured Lissamine Green Bulbar Conjunctival Staining (mm2)

    Time frame: Change from baseline to (day 30 +/- 3 days)

    The Lissamine Green (LG) bulbar conjunctival staining was analysed post-hoc for both eyes. The photos were masked and for each image the Staining Area was measured (mm2).

Secondary outcomes

  1. Change From Baseline in Visual Analogue Scale (VAS): Symptomatology Upon Waking

    Time frame: Baseline (day 0) to (day 30 +/- 3 days)

    The participant rated the severity of their symptomatology upon waking using a VAS scale. Participants put a mark on a 100 millimeter line where 0 (far left on the line) = no symptoms to 100 (far right on the line) = most severe symptoms.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 5, 2017
Registry last updated
Jun 20, 2019

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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