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

Primary Purpose

Keratoconjunctivitis Sicca

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
cyclosporine
vehicle of OTX-101
Sponsored by
Sun Pharmaceutical Industries Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconjunctivitis Sicca focused on measuring KCS, dry eye, cyclosporine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Martel Eye Medical Group
  • Cincinnati Eye Institute
  • Fifth Avenue Eye Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

OTX-101 0.09%

Vehicle

Arm Description

0.09% cyclosporine nanomicellar ophthalmic solution

vehicle of OTX-101

Outcomes

Primary Outcome Measures

Tear Production
Percentage of Eyes with Increase from Baseline of ≥ 10 mm in Schirmer's Test Score

Secondary Outcome Measures

Conjunctival Staining
change from baseline in total conjunctival staining score (lissamine green, modified National Eye Institute scale) at 12 weeks. Conjunctival Lissamine Green Staining Grades ranged from 0 (No punctate stain in zone) to 3 (Densely concentrated micropunctate stain spots)
Central Corneal Staining
change from baseline in central corneal staining score (fluorescein, modified NEI/FDA scale) at 12 weeks. The Expanded National Eye Institute (NEI)/Industry Workshop Scale for Corneal Staining Score was used to grade each of the 5 areas of the cornea on a 0 (No punctate stain in area) to 4 (Severe diffuse (coalescent) macropunctate stain of the area) scale.
Symptom Score
change from baseline in modified Symptom Assessment in Dry Eye (SANDE) score at 12 weeks. A modified SANDE instrument was used to evaluate dry eye symptoms at each visit. Subjects were asked to indicate: frequency of dry and irritated eyes on a scale of 0 (rarely) to 100 (all the time); and severity of dry eyes on a scale of 0 (very mild) to 100 (severe) The global symptom score is the square root of the frequency score times the severity score and will be completed at each visit. (range 0 to 100) Negative change from baseline indicates improvement.

Full Information

First Posted
February 13, 2016
Last Updated
August 26, 2022
Sponsor
Sun Pharmaceutical Industries Limited
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1. Study Identification

Unique Protocol Identification Number
NCT02688556
Brief Title
Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca
Acronym
Emerald
Official Title
A Randomized, Multicenter, Double-Masked, Vehicle-Controlled Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sun Pharmaceutical Industries Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconjunctivitis Sicca
Keywords
KCS, dry eye, cyclosporine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
745 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OTX-101 0.09%
Arm Type
Experimental
Arm Description
0.09% cyclosporine nanomicellar ophthalmic solution
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
vehicle of OTX-101
Intervention Type
Drug
Intervention Name(s)
cyclosporine
Other Intervention Name(s)
Seciera
Intervention Type
Drug
Intervention Name(s)
vehicle of OTX-101
Primary Outcome Measure Information:
Title
Tear Production
Description
Percentage of Eyes with Increase from Baseline of ≥ 10 mm in Schirmer's Test Score
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Conjunctival Staining
Description
change from baseline in total conjunctival staining score (lissamine green, modified National Eye Institute scale) at 12 weeks. Conjunctival Lissamine Green Staining Grades ranged from 0 (No punctate stain in zone) to 3 (Densely concentrated micropunctate stain spots)
Time Frame
Baseline and 12 weeks
Title
Central Corneal Staining
Description
change from baseline in central corneal staining score (fluorescein, modified NEI/FDA scale) at 12 weeks. The Expanded National Eye Institute (NEI)/Industry Workshop Scale for Corneal Staining Score was used to grade each of the 5 areas of the cornea on a 0 (No punctate stain in area) to 4 (Severe diffuse (coalescent) macropunctate stain of the area) scale.
Time Frame
Baseline and 12 weeks
Title
Symptom Score
Description
change from baseline in modified Symptom Assessment in Dry Eye (SANDE) score at 12 weeks. A modified SANDE instrument was used to evaluate dry eye symptoms at each visit. Subjects were asked to indicate: frequency of dry and irritated eyes on a scale of 0 (rarely) to 100 (all the time); and severity of dry eyes on a scale of 0 (very mild) to 100 (severe) The global symptom score is the square root of the frequency score times the severity score and will be completed at each visit. (range 0 to 100) Negative change from baseline indicates improvement.
Time Frame
Baseline and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Martel Eye Medical Group
City
Rancho Cordova
State/Province
California
ZIP/Postal Code
95670
Country
United States
Facility Name
Cincinnati Eye Institute
City
Edgewood
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Fifth Avenue Eye Associates
City
New York
State/Province
New York
ZIP/Postal Code
10028
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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