Ophthalmic Solution in Subjects With Dry Eye Disease (OASIS-1)

In by alicia.green

Ophthalmic Solution in Subjects With Dry Eye Disease (OASIS-1)

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A Phase 2b/3, Randomized, Double-Masked, Vehicle-Controlled Study Evaluating the Safety and Efficacy of Two Concentrations (0.4% and 1%) of ALY688 Ophthalmic Solution in Subjects With Dry Eye Disease (OASIS-1)

clinicaltrials.gov

Eligibility

Inclusion Criteria
  • Dry eye disease for > 3 months meeting specific sign and symptom criteria
  • Best corrected visual acuity of +0.6 logMAR or better
  • Willing to sign informed consent and attend study visits
  • Willing to comply with contraception requirements
Exclusion Criteria
  • Unable to meet specific sign and symptom criteria
  • Signs of ophthalmic allergic, inflammatory or infection conditions
  • Use of contact lenses
  • Anatomic abnormalities preventing accurate study assessments
  • Use of medications that influence eye dryness
  • Recent ophthalmic surgery
  • Unwilling to suspend current treatments for dry eye disease
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