RECRUITINGPhase 3INTERVENTIONAL
A Study of the Efficacy and Safety of Cyclosporin Ophthalmic Gel in Subjects With Moderate to Severe Dry Eye Disease
A Phase 3, Multicenter, Randomized, Double-blind, Vehicle-controlled Efficacy and Safety Study of Cyclosporin Ophthalmic Gel in Subjects With Moderate to Severe Dry Eye Disease
About This Trial
This study is a multicenter, randomized, double-blind, placebo-controlled, superiority design Phase III clinical trial. The primary objective is to evaluate the efficacy and safety of cyclosporine ophthalmic gel versus placebo in the treatment of moderate to severe dry eye for 84 days.
Who May Be Eligible (Plain English)
Who May Qualify:
1. aged ≥ 18 years old, males or females.
2. Subjects complained of ocular dryness in both eyes for at least 6 months at Visit 1.
3. Eye dryness score(EDS)(evaluated on a 0-100 VAS score) ≥40 at Visit 1 and Visit 2.
4. Ocular Surface Disease Index (OSDI) score ≥13 at Visit 1 and Visit 2.
5. Total corneal fluorescein staining score (tCFS) ≥2 in either eye and ≥1 in at least one region at Visit 1 and Visit 2.
6. Schirmer I test (without anesthesia) ≤ 5 mm/5 min in either eye at Visit 1 and Visit 2.
7. Subjects with moderate and severe dry eye in both eyes at Visit 1 and Visit 2:
1. Moderate: ≥1 quadrant and no more than 2 quadrants of corneal damage and/or ≥5 and \<30 corneal fluorescein staining spots on slit lamp microscopy;
2. Severe: ≥2 quadrants of corneal damage and/or ≥30 corneal fluorescence staining spots on slit lamp microscopy.
Who Should NOT Join This Trial:
1. Subjects with severe dry eye requiring surgical treatment.
2. Systemic use of retinoids within the 12 months prior to Visit 1.
3. Subjects who have had intraocular surgery within 12 months prior to Visit 1 or who require intraocular surgery during the study; or subjects who have had eyelid surgery within 6 months prior to Visit 1.
4. Subjects treated with permanent lacrimal duct embolization; or subjects treated with temporary lacrimal duct embolization within 6 months prior to Visit 1.
5. Subjects with dry eye correlated with operation；
6. Subjects who had worn corneal contact lens within 3 months prior to Visit 1.
7. Those who have used cyclosporine preparations ocularly or systemically within 1 month prior to visit 1.
8. Those who have used lifitegrast eye drops or tacrolimus eye drops ocularly within 1 month prior to visit 1.
9. Subjects with dry eye secondary to scarring (e.g., radiation exposure, ocular chemical burns, Stevens-Johnson syndrome, keloid pemphigoid, conjunctival scarring) or severe conjunctival cup cells destruction (e.g., vitamin A deficiency).
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
1. aged ≥ 18 years old, males or females.
2. Subjects complained of ocular dryness in both eyes for at least 6 months at Visit 1.
3. Eye dryness score(EDS)(evaluated on a 0-100 VAS score) ≥40 at Visit 1 and Visit 2.
4. Ocular Surface Disease Index (OSDI) score ≥13 at Visit 1 and Visit 2.
5. Total corneal fluorescein staining score (tCFS) ≥2 in either eye and ≥1 in at least one region at Visit 1 and Visit 2.
6. Schirmer I test (without anesthesia) ≤ 5 mm/5 min in either eye at Visit 1 and Visit 2.
7. Subjects with moderate and severe dry eye in both eyes at Visit 1 and Visit 2:
1. Moderate: ≥1 quadrant and no more than 2 quadrants of corneal damage and/or ≥5 and \<30 corneal fluorescein staining spots on slit lamp microscopy;
2. Severe: ≥2 quadrants of corneal damage and/or ≥30 corneal fluorescence staining spots on slit lamp microscopy.
Exclusion Criteria:
1. Subjects with severe dry eye requiring surgical treatment.
2. Systemic use of retinoids within the 12 months prior to Visit 1.
3. Subjects who have had intraocular surgery within 12 months prior to Visit 1 or who require intraocular surgery during the study; or subjects who have had eyelid surgery within 6 months prior to Visit 1.
4. Subjects treated with permanent lacrimal duct embolization; or subjects treated with temporary lacrimal duct embolization within 6 months prior to Visit 1.
5. Subjects with dry eye correlated with operation；
6. Subjects who had worn corneal contact lens within 3 months prior to Visit 1.
7. Those who have used cyclosporine preparations ocularly or systemically within 1 month prior to visit 1.
8. Those who have used lifitegrast eye drops or tacrolimus eye drops ocularly within 1 month prior to visit 1.
9. Subjects with dry eye secondary to scarring (e.g., radiation exposure, ocular chemical burns, Stevens-Johnson syndrome, keloid pemphigoid, conjunctival scarring) or severe conjunctival cup cells destruction (e.g., vitamin A deficiency).
10. Those with significant eyelid margin inflammation or meibomian gland dysfunction that, in the opinion of the investigator, may affect the outcome of the trial.
Treatments Being Tested
DRUG
Cyclosporine ophthalmic gel
Administer to eyes
DRUG
Cyclosporine ophthalmic gel vehicle
Administer to eyes
Locations (1)
Xiamen Eye Center of Xiamen University
Xiamen, Fujian, China