A Study of Hydroxypropyl Guar Galactomannan 0.25% (HPGG) Versus Vehicle in Dry Eye Patients

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00840268
First received: February 6, 2009
Last updated: September 8, 2009
Last verified: September 2009
  Purpose

The purpose of this study is to demonstrate efficacy of Hydroxypropyl Guar Galactomannan 0.25% (HPGG) Ophthalmic Gel compared to Vehicle for the treatment of dry eye.


Condition Intervention Phase
Dry Eye
Drug: HPGG 0.25% or HPGG Vehicle
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Study of Hydroxypropyl Guar Galactomannan 0.25% (HPGG) Versus Vehicle in Dry Eye Patients

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean change from baseline in sodium fluorescein corneal staining score [ Time Frame: The end of treatment period (Day 28) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change from baseline in Dry Eye Symptom Questionnaire score [ Time Frame: The end of treatment period (Day 28) ] [ Designated as safety issue: No ]

Enrollment: 427
Study Start Date: February 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
HPGG 0.25%
Drug: HPGG 0.25% or HPGG Vehicle
HPGG 0.25% versus HPGG Vehicle
Placebo Comparator: 2
HPGG Vehicle
Drug: HPGG 0.25% or HPGG Vehicle
HPGG 0.25% versus HPGG Vehicle

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The informed consent document and HIPAA privacy document must be read, signed and dated by the patient before conducting any procedures. Additionally, the informed consent document must be signed and dated by the individual obtaining consent of the patient, as well as signed and dated by a witness, if applicable.
  • Patients (minimum age 18) with dry eye. Criteria for the diagnosis must include the following two criteria at Visit 1 (Day 0).

    1. Patients' response to the self-assessment of dry eye status is at least "Some of the time" to the question, "How often have your eyes felt dry enough to want to use eye drops?".
    2. Sodium fluorescein (NaFL) corneal staining sum score of >4 in either (worse) eye using a 0-15 point grading system.
  • Able and willing to follow study instructions.
  • Patients must have best corrected visual acuity of 0.6 logMAR or better in each eye as assessed using an ETDRS chart at Visit 1.

Exclusion Criteria:

  • Diagnosis of Sjogren's syndrome (or suspected to have Sjogren's syndrome).
  • History or evidence of ocular or intraocular surgery in either eye within the last one year.
  • History or evidence of serious ocular trauma in either eye within the past six months.
  • History or evidence of corneal transplant or transplant variant procedures.
  • History of intolerance or hypersensitivity to any component of the study medications.
  • History of glaucoma or current ocular hypertension in either eye, or treatment for either condition within 6 months prior to Visit 1.
  • History or evidence of corneal conditions, other than dry eye, that may affect the corneal structure.
  • Use of any concomitant topical ocular medications including artificial tears during the study period.
  • Females of childbearing potential (those who are not surgically sterilized or postmenopausal) may not participate in the study if any of the following conditions exist:

    1. They are breastfeeding,
    2. They are unwilling to undergo urine pregnancy test at screening and upon exiting the study,
    3. They have a positive urine pregnancy test at screening,
    4. They intend to become pregnant during the study, or
    5. They do not agree to use adequate birth control methods for the duration of the study.
  • Use of RESTASIS(R) 0.05% or an ocular steroid (e.g. Lotemax(R) 0.5%) within 30 days of Visit 1.
  • Use of systemic medications that have not been stable for 30 days prior to Visit 1.
  • 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.
  • Contact lens wear during the study period. Contact lens wear must have been discontinued at least four weeks prior to Visit 1.
  • Use of punctal plugs or punctal cautery.
  • Use of lid scrubs/warm compresses within 14 days of Visit 1.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00840268

Locations
United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Jay H. Mashburn/Clinical Trial Manager, Dry Eye, Alcon Research, Ltd
ClinicalTrials.gov Identifier: NCT00840268     History of Changes
Other Study ID Numbers: C-08-34
Study First Received: February 6, 2009
Last Updated: September 8, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
OSDI
corneal staining
Dry Eye
Dry Eye Signs and Symptoms in Dry Eye Patients

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases

ClinicalTrials.gov processed this record on April 22, 2014