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A Phase 3, Multicenter, Randomized, Double- Masked and Placebo-Controlled Study Evaluating the Efficacy of a 5.0% Concentration of SAR 1118 Ophthalmic Solution Compared to Placebo in Subjects With Dry

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Trial Conditions
  • Dry Eye
  • Keratoconjunctivitis Sicca
What is the purpose of this trial?

The purpose of the study is to evaluate the efficacy of SAR 1118 Ophthalmic Solution (5.0%) compared to placebo in the treatment of Dry Eye. The safety and tolerability of SAR 1118 Ophthalmic Solution (5.0%) compared to placebo in subjects with dry eye when administered BID for 12 weeks will also be evaluated.

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

Inclusion Criteria:

- Willing and able to read, sign, and date the informed consent and HIPAA documents

- Willing and able to comply with all study procedures

- Be at least 18 years of age

- Patient-reported history of dry eye in both eyes

- Demonstrate a positive response when exposed to the Controlled Adverse Environment
model

- A negative urine pregnancy test if female of childbearing potential and must use
adequate birth control throughout the study period

Exclusion Criteria:

- Any ocular condition that, in the opinion of the Investigator, could affect study
parameters including, but not limited to, active ocular infection, ocular
inflammation, glaucoma, and/or diabetic retinopathy

- Unwilling to avoid wearing contact lenses for 7 days prior to and for duration of the
study period

- Any blood donation or significant loss of blood within 56 days of Visit 1

- Any history of immunodeficiency disorder, positive HIV, hepatitis B, C, or evidence
of acute active hepatitis A (anti-HAV IgM), or organ or bone marrow transplant.

- Use of any topical ophthalmic preparations (including artificial tear substitutes) 72
hrs prior to Visit 1 and during the study

- Any significant chronic illness that could interfere with study parameters

- History of laser‑assisted in situ keratomileusis (LASIK) or similar type of corneal
refractive surgery within 12 months prior to Visit 1, and/or any other ocular
surgical procedure within 12 months prior to Visit 1; or any scheduled ocular
surgical procedure during the study period.

- Known history of alcohol and/or drug abuse

- Subjects with Dry eye secondary to scarring or destruction of conjunctival goblet
cells (as with Vitamin A deficiency)

Gender: Both
Steward Physician(s)
  • Charles Semba, MD
Trial Interventions
Drug
  • SAR 1118
Physician Researcher

Investigator Name:

  • Charles Semba, MD

Other Information

Sponsor: SARcode Bioscience
Phase: Phase 3
Trial ID: NCT01421498
Volunteers:  Not Accepting Healthy Volunteers

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