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Effect of Cequa™ in Subjects With Dry Eye Disease

Primary Purpose

Dry Eye Disease

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

CequaTM (Cyclosporine 0.09%) ophthalmic solution

About this trial

This is an interventional treatment trial for Dry Eye Disease focused on measuring Keratoconjunctivitis Sicca, KCS, Dry eye

Eligibility Criteria

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

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Eye Associates of Fort Myers, 4225 Evans Ave.
Bowden Eye and Associates, 7205 Bonneval Road
Eye Center of N Florida, 2500 Martin Luther King Jr Blvd
Kannarr Eye Care, 2521 N Broadway
Texas Eye and Laser Center, 1872 Norwood Dr. #200

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CequaTM (Cyclosporine 0.09%) ophthalmic solution

Arm Description

Outcomes

Primary Outcome Measures

Total corneal fluorescein staining score.

Five areas of the cornea will evaluated on a 0 to 4 scale and value from 0 (absent) to 4 (severe) to each section will be allotted based on symptoms.

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.

Co-primary endpoint: total corneal fluorescein staining score

Five areas of the cornea will evaluated on a 0 to 4 scale and value from 0 (absent) to 4 (severe) to each section will be allotted based on symptoms.

Co-primary endpoint: modified symptom assessment in dry eye score

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.

Secondary Outcome Measures

Conjunctival staining assessment

Based on Investigator's judgement, 6 areas of the conjunctiva will be evaluated in a low to moderate intensity.

Changes 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 symptoms.

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).

Frequency of artificial tear product use.

Based on entries in the subject diaries, frequency of artificial tear product use will be assessed.

Schirmer's test score

Change in amount of wetting in mm and marked with a line on strip using schirmer's score. The smaller the amount of moisture on the paper, the fewer tears that person has produced.

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).

Full Information

NCT ID

NCT04357795

First Posted

April 8, 2020

Last Updated

September 8, 2022

Sponsor

Sun Pharmaceutical Industries Limited

1. Study Identification

Unique Protocol Identification Number

NCT04357795

Brief Title

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

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

June 29, 2020 (Actual)

Primary Completion Date

June 24, 2022 (Actual)

Study Completion Date

June 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sun Pharmaceutical Industries Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye Disease

Keywords

Keratoconjunctivitis Sicca, KCS, Dry eye

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

107 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CequaTM (Cyclosporine 0.09%) ophthalmic solution

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

CequaTM (Cyclosporine 0.09%) ophthalmic solution

Intervention Description

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

Primary Outcome Measure Information:

Title

Total corneal fluorescein staining score.

Description

Five areas of the cornea will evaluated on a 0 to 4 scale and value from 0 (absent) to 4 (severe) to each section will be allotted based on symptoms.

Time Frame

Week12

Title

Modified dry eye scoring.

Description

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.

Time Frame

Week12

Title

Co-primary endpoint: total corneal fluorescein staining score

Description

Five areas of the cornea will evaluated on a 0 to 4 scale and value from 0 (absent) to 4 (severe) to each section will be allotted based on symptoms.

Time Frame

Week 12

Title

Co-primary endpoint: modified symptom assessment in dry eye score

Description

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.

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

Conjunctival staining assessment

Description

Based on Investigator's judgement, 6 areas of the conjunctiva will be evaluated in a low to moderate intensity.

Time Frame

Week 12

Title

Changes in central corneal staining score

Description

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 symptoms.

Time Frame

Week 12

Title

Tear osmolarity score for both eyes

Description

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).

Time Frame

Week 12

Title

Frequency of artificial tear product use.

Description

Based on entries in the subject diaries, frequency of artificial tear product use will be assessed.

Time Frame

Week 12

Title

Schirmer's test score

Description

Change in amount of wetting in mm and marked with a line on strip using schirmer's score. The smaller the amount of moisture on the paper, the fewer tears that person has produced.

Time Frame

Week 12

Title

Percentage of subjects who prefer study treatments over prior treatment.

Description

Subjects will be asked, which treatment they prefer for the management of the dry eye (prior treatment or study treatment).

Time Frame

Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female subjects with a history of bilateral dry eye disease for a period of at least 3 months. Aged of at least 18 years. Subjects with total corneal fluorescein staining ≥6 or corneal fluorescein staining in an individual zone ≥2 as per National Eye Institute Grading Scale. Subjects with modified symptom assessment in dry eye global symptom score, ≥40 using visual analogue scale. Subjects with best-corrected visual acuity 20/200 or better in both eyes at the Screening/Baseline visit Exclusion Criteria: Subjects who have used cyclosporin 0.05% ophthalmic emulsion in both eyes for less than 3 months prior to the Screening/Baseline visit. Subjects with history of treatment failure with cyclosporin 0.05% ophthalmic emulsion. Subjects who have active seasonal and/or perennial allergic conjunctivitis in either eye. Subjects who had already Use initiated any systemic or topical ocular medication.

Facility Information:

Facility Name

Eye Associates of Fort Myers, 4225 Evans Ave.

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33901

Country

United States

Facility Name

Bowden Eye and Associates, 7205 Bonneval Road

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256

Country

United States

Facility Name

Eye Center of N Florida, 2500 Martin Luther King Jr Blvd

City

Panama City

State/Province

Florida

ZIP/Postal Code

32405

Country

United States

Facility Name

Kannarr Eye Care, 2521 N Broadway

City

Pittsburg

State/Province

Kansas

ZIP/Postal Code

66762

Country

United States

Facility Name

Texas Eye and Laser Center, 1872 Norwood Dr. #200

City

Hurst

State/Province

Texas

ZIP/Postal Code

76054

Country

United States

12. IPD Sharing Statement

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Effect of Cequa™ in Subjects With Dry Eye Disease

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