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

Dry Eye Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00840268
• Other study ID #: C-08-34
• Status: Completed
• Phase: Phase 2
• First received: February 6, 2009
• Last updated: July 15, 2014
• Start date: February 2009
• Est. completion date: July 2009

Study information

• Verified date: July 2014
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 427
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Hydroxypropyl Guar Galactomannan (HPGG) 0.25% ophthalmic gel

• Hydroxypropyl Guar Galactomannan Vehicle
Inactive ingredients used as a placebo comparator

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline in sodium fluorescein corneal staining score		Baseline (Day 7), Up to Day 28	No
Secondary	Mean change from baseline in Dry Eye Symptom Questionnaire (OSDI) score		Baseline (Day 7), Up to Day 28	No