Clinical trial NCT04357795: Effect of Cequa™ in Subjects With Dry Eye Disease
Official title: Effect of Cequa™ in Subjects With Dry Eye Disease That Is Currently Inadequately Controlled While on Cyclosporine 0.05% Ophthalmic Emulsion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye Disease
Keywords: Keratoconjunctivitis Sicca
KCS
Dry eye
Lead sponsor: Sun Pharmaceutical Industries Limited
Sponsor class: INDUSTRY
First posted: 2020-04-22
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase 4, multicenter, single arm, 12 week study in subjects with dry eye disease, which is inadequately controlled by cyclosporine 0.05% ophthalmic emulsion.

Detailed description: This is a phase 4, multicenter, open-label, single-arm, 12-week study of subjects with dry eye disease that is inadequately controlled by cyclosporine (CsA) 0.05% ophthalmic emulsion. Subject enrollment will be classified by evidence of dry eye disease (ie, signs, symptoms, or both signs and symptoms). Treatment will be one drop of CsA 0.09% ophthalmic solution (Cequa) in each eye twice daily (BID) for 12 weeks. The study hypothesis is that CsA 0.09% ophthalmic solution will show improved clinical benefit in subjects whose dry eye signs and/or symptoms are inadequately controlled while on CsA.

Eligibility criteria: Inclusion Criteria:

1. Male or female subjects with a history of bilateral dry eye disease for a period of at least 3 months.
2. Aged of at least 18 years.
3. Subjects with total corneal fluorescein staining ≥6 or corneal fluorescein staining in an individual zone ≥2 as per National Eye Institute Grading Scale.
4. Subjects with modified symptom assessment in dry eye global symptom score, ≥40 using visual analogue scale.
5. Subjects with best-corrected visual acuity 20/200 or better in both eyes at the Screening/Baseline visit

Exclusion Criteria:

1. Subjects who have used cyclosporin 0.05% ophthalmic emulsion in both eyes for less than 3 months prior to the Screening/Baseline visit.
2. Subjects with history of treatment failure with cyclosporin 0.05% ophthalmic emulsion.
3. Subjects who have active seasonal and/or perennial allergic conjunctivitis in either eye.
4. Subjects who had already Use initiated any systemic or topical ocular medication.

Primary outcomes:
measure: Mean Change in Baseline in Total Corneal Fluoroscein Staining Score
timeFrame: Week12
measure: Change From Baseline in Modified Dry Eye Scoring.
timeFrame: Week12
Secondary outcomes:
measure: Mean Change in Baseline for Conjunctival Staining Assessment
timeFrame: Week 12
measure: Changes From Baseline in Central Corneal Staining Score
timeFrame: Week 12
measure: Mean Change in Baseline for Tear Osmolarity Score for Both Eyes
timeFrame: Week 12
measure: Mean Change From Baseline in Frequency of Artificial Tear Product Use.
timeFrame: Week 12
measure: Schirmer's Test Score
timeFrame: Week 12
measure: Percentage of Subjects Who Prefer Study Treatments Over Prior Treatment.
timeFrame: Week 12
Other outcomes:
Locations:
city: Fort Myers
country: United States
facility: Eye Associates of Fort Myers, 4225 Evans Ave.
state: Florida
city: Jacksonville
country: United States
facility: Bowden Eye and Associates, 7205 Bonneval Road
state: Florida
city: Panama City
country: United States
facility: Eye Center of N Florida, 2500 Martin Luther King Jr Blvd
state: Florida
city: Pittsburg
country: United States
facility: Kannarr Eye Care, 2521 N Broadway
state: Kansas
city: Hurst
country: United States
facility: Texas Eye and Laser Center, 1872 Norwood Dr. #200
state: Texas
Study officials:
References: