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

Primary Purpose

Dry Eye

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Hydroxypropyl Guar Galactomannan (HPGG) 0.25% ophthalmic gel

Hydroxypropyl Guar Galactomannan Vehicle

About this trial

This is an interventional treatment trial for Dry Eye focused on measuring OSDI, corneal staining, Dry Eye, Dry Eye Signs and Symptoms in Dry Eye Patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

HPGG 0.25%

HPGG Vehicle

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Mean change from baseline in sodium fluorescein corneal staining score

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00840268

First Posted

February 6, 2009

Last Updated

July 15, 2014

Sponsor

Alcon Research

1. Study Identification

Unique Protocol Identification Number

NCT00840268

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

February 2009 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alcon Research

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

427 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HPGG 0.25%

Arm Type

Experimental

Arm Description

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).

Arm Title

HPGG Vehicle

Arm Type

Placebo Comparator

Arm Description

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).

Intervention Type

Drug

Intervention Name(s)

Hydroxypropyl Guar Galactomannan (HPGG) 0.25% ophthalmic gel

Other Intervention Name(s)

HPGG

Intervention Type

Drug

Intervention Name(s)

Hydroxypropyl Guar Galactomannan Vehicle

Other Intervention Name(s)

HPGG Vehicle

Intervention Description

Inactive ingredients used as a placebo comparator

Primary Outcome Measure Information:

Title

Mean change from baseline in sodium fluorescein corneal staining score

Time Frame

Baseline (Day 7), Up to Day 28

Secondary Outcome Measure Information:

Title

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

Time Frame

Baseline (Day 7), Up to Day 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jay H. Mashburn

Organizational Affiliation

Alcon Research

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

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