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

Alcon

Status and phase: Completed; Phase 2

Conditions: Dry Eye

Treatments: Drug: Hydroxypropyl Guar Galactomannan (HPGG) 0.25% ophthalmic gel; Drug: Hydroxypropyl Guar Galactomannan Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT00840268

C-08-34

Details and patient eligibility

About

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.

Full 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.

Enrollment: 427 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

427 participants in 2 patient groups, including a placebo group

HPGG 0.25%

Experimental group

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).

Treatment:

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

HPGG Vehicle

Placebo Comparator group

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).

Treatment:

Drug: Hydroxypropyl Guar Galactomannan Vehicle