HU007 Eye Drops in Patients With Dry Eye Syndrome

• Sponsor: Huons Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04384991
• Collaborator: (none)
• Enrollment: 216
• Location: 1
• Arms: 2
• Actual Duration (Months): 7.1
• Patients Per Site Per Month: 30.4

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndromes	Drug: HU007; Drug: Restasis eye drop	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 216 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 3, 2019
• Actual Primary Completion Date: Dec 5, 2019
• Actual Study Completion Date: Dec 5, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HU007 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)	Drug: HU007; Cyclosporine 0.02% with Trehalose 3%
Active Comparator: Restasis Eye drop 0.05% (Cyclosporine) 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)	Drug: Restasis eye drop; Cyclosporine 0.05%

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

3. Change from baseline in strip meniscometry [Week 4, 8, 12]

   Change from baseline in strip meniscometry at Week 4, 8, 12

4. 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

5. 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

6. Time to achieve 100% clearance on the corneal staining score [upto week 12]

   Time to achieve 100% clearance on the corneal staining score

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Seongnam		Korea, Republic of

Sponsors and Collaborators

• Huons Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Huons Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04384991
• Other Study ID Numbers: HU-007_P3-1
• First Posted: May 12, 2020
• Last Update Posted: May 12, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Syndrome; Ophthalmic Solutions

Study Results

No Results Posted as of May 12, 2020