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OpenTrials
Completed

NCT Number: NCT00761202

Performance and Acceptance of Optive Versus Hylocomod Eyedrops in Patients With Dry Eye Symptoms

This study evaluates the performance and acceptance of Optive versus Hylocomod eyedrops, when administered for one month to patients with mild to moderate dry eye symptoms, with and without contact lenses.

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Key information

Conditions

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

London, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years or over
  • Contact lens wearer, spectacle wearer or non-spectacle wearer
  • Mild to severe dry eye symptoms, defined as OSDI score 13 to 100
  • Mild to moderate conjunctival staining in each eye and/or mild to moderate corneal staining in each eye
  • Best corrected visual acuity of 6/9 in each eye

Exclusion criteria

  • Previously used Hylocomod or Optive eyedrops
  • Systemic allergy or eye allergy
  • Systemic disease which might have an ocular component and/or interfere with contact lens wear
  • Autoimmune disease which might have an ocular component and/or interfere with contact lens wear
  • Systemic medication which might have eye side effects and or interfere with contact lens wear
  • Eye infection or use of eye medication

Treatment and study plan

A sterile solution containing sodium carboxymethylcellulose and glycerin, preserved with PURITE®

Drug

Eyedrops as required, but at least 3 times per day

Other names: Optive™ Eyedrops

Sodium Hyaluronate

Drug

Eyedrops as required, but at least 3 times per day

Other names: Hylocomod

Primary outcomes

  1. Conjunctival Staining by Lissamine Green

    Time frame: week 1, month 1

    Percentage of cases of limbal staining by lissamine green at each point on a five point scale (0 = None, 1 = Trace, 2 = Mild, 3 = Moderate, 4 = Severe)

Secondary outcomes

  1. Corneal Staining by Fluorescein

    Time frame: week 1, month 1

    Percentage of cases of limbal staining by sodium fluorescein at each point on a five point scale (0 = None, 1 = Trace, 2 = Mild, 3 = Moderate, 4 = Severe)

  2. Conjunctival Hyperaemia

    Time frame: week 1, month 1

    Percentage of conjunctival response reported in terms of limbal hyperaemia for the worst responses over the area at each point on a five point scale (0=clear/white conjunctiva, 1=slight redness, 2=Mild redness, 3=Moderate redness, 4=Severe redness)

  3. Ocular Comfort and Ocular Symptoms on Visual Analogue Scale

    Time frame: week 1, month 1

    Mean comfort judged on a 100 point visual analogue scale (0=Very Poor, 100=Excellent)

  4. Daily Eyedrop Usage

    Time frame: Month 1

    Average daily eyedrop use

  5. Lipid Layer Pattern Assessment

    Time frame: Week 1, month 1

    Lipid layer thickness as determined by lipid layer mixing pattern. A high mixing pattern = thick lipid layer.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 29, 2008
Registry last updated
Nov 19, 2013

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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