HU007 Eye Drops in Patients With Dry Eye Syndrome

Phase 3

Completed

• Conditions: Dry Eye Syndromes
• Interventions: Drug: Restasis eye drop; Drug: HU007

• Registration Number: NCT04384991
• Lead Sponsor: Huons Co., Ltd.

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-03
• Study First Submitted: 2019-08-16
• Primary Completion: 2019-12-05
• Study Completion: 2019-12-05
• Status Verified: 2020-05
• Study First Submitted QC: 2020-05-11
• Last Update Submitted: 2020-05-11
• Study First Posted: 2020-05-12
• Last Update Posted: 2020-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 216

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Restasis Eye drop 0.05% (Cyclosporine)	Restasis eye drop	Adminster twice a day(one drop would be administered to both eyes once a time). When being administered, the IP should be mixed by upside down. Medication is recommended at 9AM(±1H) and 9PM(±1H)
HU007 Eye drop	HU007	Adminster twice a day(one drop would be administered to both eyes once a time). When being administered, the IP should be mixed by upside down. Medication is recommended at 9AM(±1H) and 9PM(±1H)

Primary Outcome Measures

Name	Time	Method
Change from baseline in corneal staining score-Oxford grading	Week 12	Change from baseline in corneal staining score-Oxford grading at Week 12

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of