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Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca (Emerald)

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Sun Pharma

Status and phase

Completed
Phase 3

Conditions

Keratoconjunctivitis Sicca

Treatments

Drug: cyclosporine
Drug: vehicle of OTX-101

Study type

Interventional

Funder types

Industry

Identifiers

NCT02688556
OTX-101-2016-001

Details and patient eligibility

About

This is a randomized, double-masked, vehicle-controlled study of the safety and efficacy of OTX-101 (0.09% cyclosporine nanomicellar solution) in the treatment of keratoconjunctivitis sicca to be conducted at approximately 50 sites.

Enrollment

745 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • History of dry eye syndrome (KCS) for a period of at least 6 months
  • Clinical diagnosis of bilateral KCS
  • Lissamine green conjunctival staining sum score of ≥ 3 to ≤ 9 out of a total possible score of 12 (scoring excludes superior zones 2 and 4) in the same eye at both the Screening and Baseline Visits.
  • Global symptom score (SANDE) ≥ 40 mm at both the Screening and Baseline Visits
  • Corrected Snellen visual acuity (VA) of better than 20/200 in each eye.

Exclusion criteria

  • Use of cyclosporine ophthalmic emulsion 0.05% (Restasis®) within 3 months prior to the Screening Visit.
  • Previous treatment failure (lack of efficacy) with cyclosporine ophthalmic emulsion 0.05% (Restasis).
  • Diagnosis of Sjögren's disease ˃ 5 years prior to the Screening Visit.
  • Clinical diagnosis or any history of seasonal and/or perennial allergic conjunctivitis.
  • Use of systemic or topical medications within 7 days prior to the Screening Visit or during the study period that are known to cause dry eye.
  • Use of any topical ophthalmic medications, prescription (including anti-glaucoma medications) or over the counter (including artificial tears), other than the assigned study medication during the study period.
  • Current active eye disease other than dry wyw syndrome (i.e., any disease for which topical or systemic ophthalmic medication is necessary).
  • History of herpes keratitis.
  • Corneal transplant
  • Corneal refractive surgery within 6 months prior to the Screening Visit or postoperative refractive surgery symptoms of dryness that have not resolved.
  • Cataract surgery within 3 months prior to the Screening Visit.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

745 participants in 2 patient groups, including a placebo group

OTX-101 0.09%
Experimental group
Description:
0.09% cyclosporine nanomicellar ophthalmic solution
Treatment:
Drug: cyclosporine
Vehicle
Placebo Comparator group
Description:
vehicle of OTX-101
Treatment:
Drug: vehicle of OTX-101

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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