Phase 4
N=134
Effect of Cequa™ in Subjects With Dry Eye Disease
Dry Eye Disease
Bottom Line
View on ClinicalTrials.gov: NCT04357795 ↗Enrolled (actual)
134
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Mean Change in Baseline in Total Corneal Fluoroscein Staining Score — -3.1 score on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- CequaTM (Cyclosporine 0.09%) ophthalmic solution (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sun Pharmaceutical Industries Limited
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Baseline in Total Corneal Fluoroscein Staining Score |
-3.1 | <0.0001 sig |
| PRIMARY Change From Baseline in Modified Dry Eye Scoring. |
-29.14 | <0.0001 sig |
| SECONDARY Mean Change in Baseline for Conjunctival Staining Assessment |
-2.35 | <0.0001 sig |
| SECONDARY Changes From Baseline in Central Corneal Staining Score |
-0.5 | <0.0001 sig |
| SECONDARY Mean Change in Baseline for Tear Osmolarity Score for Both Eyes |
-4.0; -11.7 | 0.0323 sig |
| SECONDARY Mean Change From Baseline in Frequency of Artificial Tear Product Use. |
-1.5 | <0.0001 sig |
| SECONDARY Schirmer's Test Score |
2.4 | 0.0029 sig |
| SECONDARY Percentage of Subjects Who Prefer Study Treatments Over Prior Treatment. |
21.8; 69.4 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT04357795). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.