A Study of AGN-195263 for the Treatment of Meibomian Gland Dysfunction

Allergan

Status and phase: Completed; Phase 2

Conditions: Meibomian Gland Dysfunction

Treatments: Drug: AGN-195263 0.03%; Drug: AGN-195263 Vehicle; Drug: AGN-195263 0.1%; Drug: AGN-195263 0.01%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01633788

195263-006

Details and patient eligibility

About

This study will evaluate the safety and efficacy of AGN-195263 compared to vehicle in patients with meibomian gland dysfunction (MGD) in the eyelids.

Enrollment: 232 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Meibomian gland dysfunction in both eyes
• Best-corrected visual acuity of 20/40 or better in each eye

Exclusion criteria

• Known or suspected prostate cancer
• History of breast cancer
• Using LATISSE® or any other eye lash growth-stimulating product at least 30 days prior to the screening visit, or anticipated use during the study
• Contact lens wear in either eye during any portion of the study
• Unable to instill eye drops correctly
• History of corneal refractive surgery in either eye within 1 year

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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232 participants in 4 patient groups, including a placebo group

AGN-195263 0.1%

Experimental group

Description:

1 drop of AGN-195263 0.1% instilled in each eye twice daily.

Treatment:

Drug: AGN-195263 0.1%

AGN-195263 0.03%

Experimental group

Description:

1 drop of AGN-195263 0.03% instilled in each eye twice daily.

Treatment:

Drug: AGN-195263 0.03%

AGN-195263 0.01%

Experimental group

Description:

1 drop of AGN-195263 0.01% instilled in each eye twice daily.

Treatment:

Drug: AGN-195263 0.01%

AGN-195263 Vehicle

Placebo Comparator group

Description:

1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.

Treatment:

Drug: AGN-195263 Vehicle