Phase III Confirmatory Study of DE-089 Ophthalmic Solution in Patients With Dry Eye

NCT01240382 | Completed Phase 3 Results

• 1 other identifier: 00890602
• Study Type: interventional
• Target: 332
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate that the efficacy of 3% DE-089 ophthalmic solution (one drop at a time, 6 times daily, 4 weeks topical administration), in comparison to 0.1% sodium hyaluronate ophthalmic solution (0.1% HA) (one drop at a time, 6 times daily, 4 weeks topical administration), is at least non-inferior in the change in fluorescein staining score, and is superior in the change in Rose bengal score, in a multicenter, double-masked, parallel-group comparison study. Safety profile will likewise be compared.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (2)

• Mean Change in Fluorescein Staining Score From Baseline

  Fluorescein staining was scored according to the protocol by Shimmura et al. The cornea was divided into 3 equal zones: upper, middle, and lower. Each zone had a staining score ranging between 0 and 3 points, with minimum and maximum total staining scores ranging between 0 and 9 points. 0 is better. The degree of staining with Fluorescein dyes was scored as follows: 0 = no staining, 1= staining of less than half of the area, 2= staining of more than half of the area, 3= staining in the whole area.

  Baseline and 4-week (discontinued (LOCF))

• Mean Change in Rose Bengal Staining Score From Baseline

  Rose bengal staining were scored according to the protocol by Shimmura et al. The ocular surface was divided into 5 zones: nasal and temporal conjunctival, and upper, middle, and lower corneal areas. A staining score between 0 and 3 points was used in each zone, with the minimum and maximum total staining scores ranging between 0 and 15 points.0 is better. The degree of staining with Rose bengal dyes was scored as follows: 0 = no staining, 1= staining of less than half of the area, 2= staining of more than half of the area, 3= staining in the whole area.

  Baseline and 4-week (discontinued (LOCF))

Study Arms (2)

3% DE-089

EXPERIMENTAL

Drug: 3% DE-089 ophthalmic solution

0.1% HA

ACTIVE COMPARATOR

Drug: 0.1% sodium hyaluronate ophthalmic solution

Interventions

3% DE-089 ophthalmic solution DRUG

3% DE-089

0.1% sodium hyaluronate ophthalmic solution DRUG

0.1% HA

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Those who show:
• Keratoconjunctival disorder confirmed with vital dye staining
• Abnormal Schirmer score results

You may not qualify if:

• Eye disease that needs therapy other than that for dry eye
• Those who need to wear contact lenses during the clinical study

Sponsors & Collaborators

• Santen Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Santen study sites

Osaka, Osaka, Japan

Location

Related Publications (1)

• Takamura E, Tsubota K, Watanabe H, Ohashi Y; Diquafosol Ophthalmic Solution Phase 3 Study Group. A randomised, double-masked comparison study of diquafosol versus sodium hyaluronate ophthalmic solutions in dry eye patients. Br J Ophthalmol. 2012 Oct;96(10):1310-5. doi: 10.1136/bjophthalmol-2011-301448. Epub 2012 Aug 21.

  PMID: 22914501 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: General Manager of Clinical Development Group
• Organization: Santen Pharmaceutical Co., Ltd.

clinical@santen.co.jp

+81-6-4802-9341

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 12, 2010
• First Posted: November 15, 2010
• Primary Completion: February 1, 2008
• Last Updated: August 13, 2014
• Results First Posted: August 8, 2014

Record last verified: 2014-08

Locations

JP (1)