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

NCT00840268 | Completed Phase 2

• 1 other identifier: C-08-34
• Study Type: interventional
• Target: 427
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Dry Eye

Keywords

OSDI; corneal staining; Dry Eye; Dry Eye Signs and Symptoms in Dry Eye Patients

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline in sodium fluorescein corneal staining score

  Baseline (Day 7), Up to Day 28

Secondary Outcomes (1)

• Mean change from baseline in Dry Eye Symptom Questionnaire (OSDI) score

  Baseline (Day 7), Up to Day 28

Study Arms (2)

HPGG 0.25%

EXPERIMENTAL

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

HPGG Vehicle

PLACEBO COMPARATOR

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

Interventions

Hydroxypropyl Guar Galactomannan (HPGG) 0.25% ophthalmic gel DRUG

Also known as: HPGG

HPGG 0.25%

Hydroxypropyl Guar Galactomannan Vehicle DRUG

Inactive ingredients used as a placebo comparator

Also known as: HPGG Vehicle

HPGG Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Jay H. Mashburn

  Alcon Research

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2009
• First Posted: February 10, 2009
• Study Start: February 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: July 17, 2014

Record last verified: 2014-07