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Clinical Trials/NCT00761202
NCT00761202CompletedPhase 4

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

Allergan0 sites50 target enrollmentStarted: August 2007Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Allergan
Enrollment
50
Primary Endpoint
Conjunctival Staining by Lissamine Green
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

1

Active Comparator

Optive Eyedrops

Intervention: A sterile solution containing sodium carboxymethylcellulose and glycerin, preserved with PURITE® (Drug)

2

Active Comparator

Hylocomod Eyedrops

Intervention: Sodium hyaluronate (Drug)

Outcomes

Primary Outcomes

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

  • Ocular Comfort and Ocular Symptoms on Visual Analogue Scale(week 1, month 1)
  • Corneal Staining by Fluorescein(week 1, month 1)
  • Conjunctival Hyperaemia(week 1, month 1)
  • Daily Eyedrop Usage(Month 1)
  • Lipid Layer Pattern Assessment(Week 1, month 1)

Investigators

Sponsor
Allergan
Sponsor Class
Industry
Responsible Party
Sponsor

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Performance and Acceptance of Optive... | Clinical Trial