Effect of Cequa™ in Subjects With Dry Eye Disease

NCT04357795 | Completed Phase 4 Results FDA Drug

• 1 other identifier: OTX101-2019-001
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 5

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.

Conditions

Dry Eye Disease

Keywords

Keratoconjunctivitis Sicca; KCS; Dry eye

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Mean Change in Baseline for Conjunctival Staining Assessment

  Week 12

• Changes From Baseline in Central Corneal Staining Score

  Week 12

• Mean Change in Baseline for Tear Osmolarity Score for Both Eyes

  Week 12

• Mean Change From Baseline in Frequency of Artificial Tear Product Use.

  Week 12

• Schirmer's Test Score

  Week 12

Study Arms (1)

CequaTM (Cyclosporine 0.09%) ophthalmic solution

EXPERIMENTAL

Drug: CequaTM (Cyclosporine 0.09%) ophthalmic solution

Interventions

CequaTM (Cyclosporine 0.09%) ophthalmic solution DRUG

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

CequaTM (Cyclosporine 0.09%) ophthalmic solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Pharmaceutical Industries Limited: lead

Study Sites (5)

Eye Associates of Fort Myers, 4225 Evans Ave.

Fort Myers, Florida, 33901, United States

Location

Bowden Eye and Associates, 7205 Bonneval Road

Jacksonville, Florida, 32256, United States

Location

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

Panama City, Florida, 32405, United States

Location

Kannarr Eye Care, 2521 N Broadway

Pittsburg, Kansas, 66762, United States

Location

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

Hurst, Texas, 76054, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Keratoconjunctivitis Sicca

Interventions

Cyclosporine; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Results Point of Contact

• Title: Head-Clinical Development
• Organization: Sun Pharmaceutical Industries Limited

clinical.trial@sunpharma.com

2266455645

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 22, 2020
• Study Start: June 29, 2020
• Primary Completion: June 24, 2022
• Study Completion: June 24, 2022
• Last Updated: February 6, 2024
• Results First Posted: February 6, 2024

Record last verified: 2023-10

Locations

US (5)