Comparison of Tolerability and Clinical Performance of Two Emulsion-type Artificial Tears

Hom, Milton M., OD, FAAO

Status and phase: Unknown; Phase 3

Conditions: Dry Eye

Treatments: Other: Emulsion type artificial tear

Study type: Interventional

Funder types: Industry

Identifiers

NCT01335126

AG9965-007

Details and patient eligibility

About

The purpose of this study is to evaluate the performance between two emulsion-type artificial tears.

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Between the ages of 18 and over inclusive.
• Males or females
• Patient is in generally good & stable overall health.
• Patient likely to comply with study guidelines & study visits.
• Informed consent signed.
• OSDI score >18 OR
• TBUT <10 seconds

Exclusion criteria

• Corneal refractive surgery or contact lens wear within 6 months of this study.
• Current use of Restasis
• Intra-ocular surgery within 6 months or ocular laser surgery within 6 months.
• Pregnant or lactating women.
• Ocular pathology (includes glaucoma and cataract), which could impact results and/or place patient at risk.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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48 participants in 1 patient group

Test

Experimental group

Treatment:

Other: Emulsion type artificial tear