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CompletedNCT00809198Updated Feb 3, 2012

Kynex Versus Refresh Plus Study in Subject With Dry Eye

A Phase 4 interventional study of Sodium Hyaluronate and Carboxymethylcellulose sodium in Dry Eye, sponsored by Alcon Research. Completed. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2012-02-03.

Sponsored by Alcon Research (part of Alcon) · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
67
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study summary

The effect of Kynex versus Refresh Plus in subjects with mild to moderate dry eye.

02

Conditions studied

  • Dry Eye

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Keywords

  • Sodium Hyaluronate, Kynex, Carboxymethylcellulose sodium
  • Refresh Plus
  • Dry Eye
  • Cornea Staining
  • TBUT
03

In context

Dry Eye Syndromes

1,325 studies on the registry are indexed under Dry Eye Syndromes; 193 are open to participants now.

This study's enrollment of 67 is above the median of 60 across 1,103 interventional studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

Alcon Research is the lead sponsor of 624 studies on the registry; 9 are open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 100 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 20 years of age or older, of any race and either sex.
  • Able to understand and sign an informed consent that has been approved by an Institutional Review Board.
  • Criteria for the diagnosis must include the following two characteristics at Visit 1 (Day 1):
  • Subjects' assessment of dry eye status (answer of at least "Some of the time" to the question, "How often have your eyes felt dry enough to want to use eye drops?"
  • Sodium fluorescein (NaFl) corneal staining score sum of ≥3 in either eye (NEI scoring system).
  • Able and willing to follow study instructions.

Exclusion criteria

Exclusion Criteria:

  • Subjects who meet any of the following criteria will be excluded from this study:
  • History or evidence of ocular or intraocular surgery in either eye within the past three months.
  • History of intolerance or hypersensitivity to any component of the study medications.
  • History or evidence of epithelial herpes simplex keratitis (dendrictic keratitis); vaccine, active or recent varicella viral disease of the cornea and/or conjunctiva; ocular rosacea; chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye.
  • Use of topical ocular medications during the study period.
  • Subjects using systemic medications that may contribute to dry eye (e.g. cold and allergy medications, tricyclic antidepressants, hormone replacement therapies) may not be enrolled in the study unless they have been on a stable dosing regimen for a minimum of 30 days prior to Visit 1. In addition, the dosing regimen must remain stable throughout the study.
  • Presence of ocular conditions such as active acute blepharitis, conjunctival infections, iritis, or any other ocular condition that may preclude the safe administration of the test article.
  • Subjects unwilling to discontinue contact lens wear during the study period. Contact lens wear must have been discontinued at least one week prior to Visit 1.
  • Current punctal occlusion of any type (e.g. collagen plugs, silicone plugs).
  • Enrollment of the investigator or his or her staff, family members of the investigator, family members of the investigator's staff, or individuals living in the households of these individuals.
  • Participation in any investigational drug or device study within 30 days of entering this study.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
67 participants (actual)

Study arms

  • Experimental
    Sodium Hyaluronate

    Sodium Hyaluronate (Kynex)

    Other: Sodium Hyaluronate

  • Active comparator
    Carboxymethylcellulose sodium

    Carboxymethylcellulose sodium (Refresh Plus)

    Other: Carboxymethylcellulose sodium

Interventions

  • OtherSodium Hyaluronate

    Also known as: Kynex

  • OtherCarboxymethylcellulose sodium

    Also known as: Refresh Plus

06

What researchers measure

Primary outcomes

  1. Cornea Staining Score

    Time frame: 8 weeks

Secondary outcomes

  1. Dry Eye and symptoms

    Time frame: 8 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00809198
Lead sponsor
Alcon Research
Responsible party
Sponsor
First posted
Dec 17, 2008
Start date
Dec 2008
Primary completion
May 2009
Completion
May 2009
Last update
Feb 3, 2012

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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