Effect of Cequa™ in Subjects With Dry Eye Disease

Dry Eye Disease Clinical Trial

Official title:

Effect of Cequa™ in Subjects With Dry Eye Disease That Is Currently Inadequately Controlled While on Cyclosporine 0.05% Ophthalmic Emulsion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04357795
• Other study ID #: OTX101-2019-001
• Status: Completed
• Phase: Phase 4
• Start date: June 29, 2020
• Est. completion date: June 24, 2022

Study information

• Verified date: October 2023
• Source: Sun Pharmaceutical Industries Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: June 24, 2022
• Est. primary completion date: June 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• CequaTM (Cyclosporine 0.09%) ophthalmic solution
One drop CequaTM (Cyclosporine 0.09%) ophthalmic solution in each eye twice daily, approximately 12 hours apart.

Locations

Country	Name	City	State
United States	Eye Associates of Fort Myers, 4225 Evans Ave.	Fort Myers	Florida
United States	Texas Eye and Laser Center, 1872 Norwood Dr. #200	Hurst	Texas
United States	Bowden Eye and Associates, 7205 Bonneval Road	Jacksonville	Florida
United States	Eye Center of N Florida, 2500 Martin Luther King Jr Blvd	Panama City	Florida
United States	Kannarr Eye Care, 2521 N Broadway	Pittsburg	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Sun Pharmaceutical Industries Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change in Baseline in Total Corneal Fluoroscein Staining Score	Scale for Corneal Staining as defined by the FDA/NEI: 0-4 (0-no staining, 4-severe staining). The higher number indicates more severe. The lower the number indicates less severe staining on the cornea	Week12
Primary	Change From Baseline in Modified Dry Eye Scoring.	Based on questionnaire asked to subjects (sign and symptoms), modified symptom of dry eye score (range 0 to 100) will be assessed. Increase in score will indicate severity in the symptoms.	Week12
Secondary	Mean Change in Baseline for Conjunctival Staining Assessment	Based on Investigator's judgement, 6 areas of the conjunctiva will be evaluated in a low to moderate intensity.; Scale for Conjunctival Staining defined: 0-6 (0 no staining, 6-severe staining). The higher the number indicates more severe. The lower the number indicates less severe staining on the conjunctival	Week 12
Secondary	Changes From Baseline in Central Corneal Staining Score	Five areas of cornea will be evaluated on a 0 to 4 scale and value from 0 (absent) to 4 (severe) to each section will be allotted based on NEI grading scale	Week 12
Secondary	Mean Change in Baseline for Tear Osmolarity Score for Both Eyes	Tear osmolarity of both the eyes will be assessed and score (mOsm/L) will be allotted to each eye. Higher score will indicate severity of the disease (dry eye).; Tear osmolarity OU was assessed using the TearLab Osmolarity System Test by collecting nanoliter volumes of tear fluid at each visit from each eyelid margin using the Osmolarity Test Pen and Test Card. Results were interpreted according to the provided instructions and scores (mOsm/L) for each eye were recorded. Normal, mild/moderate, and severe dry eyes had average tear osmolarity values of approximately 302+/-8 mOsm/L, 315+/-10 mOsm/L and 336+/022 mOsm/L, respectively.	Week 12
Secondary	Mean Change From Baseline in Frequency of Artificial Tear Product Use.	Based on entries in the subject diaries, frequency of artificial tear product use will be assessed.; Frequency for artificial tear: This is number of times per day recorded in a daily diary log assessed at baseline and week 12. The higher the number the worse the outcome. The lower the number the better the outcome	Week 12
Secondary	Schirmer's Test Score	An unanesthetized Schirmer's test was performed in each eye at least 5 minutes after the lissamine green conjunctival staining to allow for any reflex tearing to subside. At each visit, strips were placed OU at the same time and timed for 5 min. Strips were removed after 5 min and the amount of wetting was recorded in mm and also marked with a line on the strip. The Investigator recorded a score for each eye. A score of greater than 10 mm in 5 minutes is accepted as normal. A score of less than 5 mm in 5 minutes indicates a tear deficiency. A score less than 10 mm in 5 minutes indicates a change from normal in tear production.	Week 12
Secondary	Percentage of Subjects Who Prefer Study Treatments Over Prior Treatment.	Subjects will be asked, which treatment they prefer for the management of the dry eye (prior treatment or study treatment).; Note- For this outcome measure, participants were provided the option to not choose either treatment as the preferred treatment.	Week 12