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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00840268
First received: February 6, 2009
Last updated: July 15, 2014
Last verified: July 2014
  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: Hydroxypropyl Guar Galactomannan (HPGG) 0.25% ophthalmic gel
Drug: Hydroxypropyl Guar Galactomannan Vehicle
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

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: Baseline (Day 7), Up to Day 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change from baseline in Dry Eye Symptom Questionnaire (OSDI) score [ Time Frame: Baseline (Day 7), Up to Day 28 ] [ Designated as safety issue: No ]

Enrollment: 427
Study Start Date: February 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HPGG 0.25%
Hydroxypropyl Guar Galactomannan (HPGG) 0.25% ophthalmic gel, 1 drop per eye twice daily (BID) (in the morning upon awakening and in the evening prior to bedtime) for 21 days (Treatment phase).
Drug: Hydroxypropyl Guar Galactomannan (HPGG) 0.25% ophthalmic gel
Other Name: HPGG
Placebo Comparator: HPGG Vehicle
Hydroxypropyl Guar Galactomannan Vehicle, 1 drop per eye twice daily (BID) (in the morning upon awakening and in the evening prior to bedtime) for 21 days (Treatment phase).
Drug: Hydroxypropyl Guar Galactomannan Vehicle
Inactive ingredients used as a placebo comparator
Other Name: HPGG Vehicle

Detailed Description:

A 7-day Vehicle pre-randomization (run-in) phase during which all patients will receive 1 drop of Vehicle in each eye twice daily will precede the 21-day treatment phase, for an overall study duration of 28 days.

  Eligibility

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

Inclusion Criteria:

  • Must read, sign, and date an informed consent document and HIPAA privacy document.
  • Diagnosis of dry eye at Visit 1 (Day 0).
  • Able and willing to follow study instructions.
  • Best corrected visual acuity (BCVA) of 0.6 logMAR or better in each eye as assessed using an ETDRS chart at Visit 1.
  • Other protocol-defined inclusion criteria may apply.

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 previous year.
  • History or evidence of serious ocular trauma in either eye within the previous 6 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 if breastfeeding, unwilling to undergo urine pregnancy test at screening and upon exiting the study, have a positive urine pregnancy test at screening, intend to become pregnant during the study, or do not agree to use adequate birth control methods for the duration of the study.
  • Use of RESTASIS® 0.05% or an ocular steroid within 30 days of Visit 1.
  • Use of systemic medications that have not been stable for 30 days prior to Visit 1.
  • Any ocular condition that may preclude the safe administration of the test article.
  • Unwilling to discontinue contact lens wear at least 4 weeks prior to Visit 1, and during the study period.
  • Use of punctal plugs or punctal cautery.
  • Use of lid scrubs/warm compresses within 14 days of Visit 1.
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00840268

Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Jay H. Mashburn Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00840268     History of Changes
Other Study ID Numbers: C-08-34
Study First Received: February 6, 2009
Last Updated: July 15, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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
Ophthalmic Solutions
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014