HU007 Eye Drops in Patients With Dry Eye Syndrome

Dry Eye Syndromes Clinical Trial

Official title:

A Multicenter, Randomized, Double Blind, Restasis-controlled Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of HU007 Eye Drops in Patients With Dry Eye Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04384991
• Other study ID #: HU-007_P3-1
• Status: Completed
• Phase: Phase 3
• Start date: May 3, 2019
• Est. completion date: December 5, 2019

Study information

• Verified date: May 2020
• Source: Huons Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a multicenter, randomized, double blind, Restasis-controlled non-inferiority, Phase III Study to evaluate the efficacy and safety of HU007 eye drops in patients With dry eye syndrome

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: December 5, 2019
• Est. primary completion date: December 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Male and Female who over 19 years old

• Those who meet below criteria at least one of two eyes

1. Those who have over than score 2 in corneal staining test-Oxford grading

2. Tear secretion test without anesthesia(Schirmer test) result would be under 10mm/5min (If the test result is 0mm/5min, it should be over than 3mm/5min on the nasal stimulation schirmer test in the same eye)

3. TBUT(Tear film break-up time) test result should be under 10sec.

• Woman with no possibility of pregnancy or negative pregnancy test results at a screening visit, Women or men who have agreed to maintain at least one contraceptive method during study period

• Those who could understand this study and agree to informed consent voluntarily

Exclusion Criteria:

• Those who have clinically significant eye disease not related to dry eye symdrome

• Those who are in anti-inflammatory medication for dry eye syndrome

• Medication of systemic steroid or immunosuppressant

• Those who have worn contact lenses before 72hours or have to wear contact lenses or disagree not to wear contact lenses during study period

• Those who have medical history with intraocular surgery 90 days before screening visit

• Those who have any active ophthalmic diseases such as active allergy, anterior uveitis, stevens-johnson syndrom which could affect the surfece of eye

• Those who have any autoimmune diseases

• Those who need a surgery for surface elevation caused by meibomian gland dysfunction(MGD)

• Those who have any medical history of corneal transplantation or neurotrophic keratitis

• Those who have diagnosed with glaucoma or have an intraocular pressure over than 25mmHg at least in one of the eyes

• Those who have medicated cyclosporine or steroid eye-drops 30 days before screening visit

• Those who have underwent any eye correction surgery such as LASIK(Laser-assistant in situ keratomileusis) 12 months before screening visit

• Those who have underwent a silicone lacrimal punctal occlusion or cauterization of the punctum excluding collagen lacrimal punctal occlusion 90 days before screening visit

• Those who have a hypersensitivity reaction for cyclosporine, trehalose or protein-based medication related to investigational drug

• Those who have diagnosed a psychical disorder which could affect this study

• Women who is pregnant or breastfeeding or those who have a plan to be pregnant

• Those who have medical history on abusing medications or alchol

• Those who have received other investigational drugs/devices 30 days before screening visit

• Those who are inappropriate for participating in this study according to investigator's judgement

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Syndrome

Intervention

Drug:
• HU007
Cyclosporine 0.02% with Trehalose 3%
• Restasis eye drop
Cyclosporine 0.05%

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam

Sponsors (1)

Lead Sponsor	Collaborator
Huons Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in corneal staining score-Oxford grading	Change from baseline in corneal staining score-Oxford grading at Week 12	Week 12
Secondary	Change from baseline in corneal staining score-Oxford grading	Change from baseline in corneal staining score-Oxford grading at Week 4, 8	Week 4, 8
Secondary	Change from baseline in conjunctival staining score-Oxford grading	Change from baseline in conjunctival staining score-Oxford grading at Week 4, 8, 12	Week 4, 8, 12
Secondary	Change from baseline in strip meniscometry	Change from baseline in strip meniscometry at Week 4, 8, 12	Week 4, 8, 12
Secondary	Change from baseline in Tear film break-up time	Change from baseline in Tear film break-up time at Week 4, 8, 12	at Week 4, 8, 12
Secondary	Change from Baseline of Standard patient evaluation of eye dryness questionnaire	Change from Baseline of Standard patient evaluation of eye dryness questionnaire at Week 4, 8, 12	at Week 4, 8, 12
Secondary	Time to achieve 100% clearance on the corneal staining score	Time to achieve 100% clearance on the corneal staining score	upto week 12