A Study to Evaluate the Safety and Effectiveness of Restylane-Defyne for Punctual Occlusion

Mild to Moderate Dry Eye Disease Clinical Trial

Official title:

A Single-Arm, Single-Center, Randomized, Single-Masked Study to Evaluate Restylane Defyne for Canalicular Occlusion in Participants With Mild to Moderate Dry Eye Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03709641
• Other study ID #: 0918
• Status: Completed
• Phase: N/A
• Start date: October 17, 2018
• Est. completion date: November 28, 2018

Study information

• Verified date: December 2018
• Source: The Eye Care Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A study which participants with mild to moderate dry eye disease will have a punctum of one eye injected with Restyalne Defyne and the other eye injected with saline solution. Participants will be evaluated over four visits.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: November 28, 2018
• Est. primary completion date: November 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

Inclusion Criteria:

• Twenty-one (21) to 80 years of age

• Baseline Ocular Surface Disease Index score of at least 13 with no more than 3 responses of "not applicable" for each eye individually

• In the study eye, a baseline Schirmer test with anesthetic of = 10 mm/5 minute

• Literate, able to speak English and able to complete the questionnaire independently

• Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol.

Exclusion Criteria:

• Use of ophthalmic cyclosporine or lifitegrast within 30 days prior to Day 0.

• History of surgical punctal occlusion (e.g., cautery), canalicular infection or canalicular surgery.

• Corneal transplant in either eye

• Ocular surgery (such as cataract surgery or LASIK) in either eye within six months of the Baseline Visit.

• A systemic condition or disease not stabilized or judged by the investigator to be incompatible with participation in the study (e.g. current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease).

• The history or presence of any ocular disorder or condition in either eye that, in the opinion of the investigator, would interfere with the interpretation of the study results (e.g., significant corneal or conjunctival scarring, pterygium or nodular pinguecula; current ocular infection (except mild blepharitis), conjunctivitis or inflammation not associated with dry eye; anterior (epithelial) basement membrane corneal dystrophy or other clinically significant corneal dystrophy or degeneration; history of ocular herpetic infection; evidence of keratoconus; lid or lacrimal cancer.

• Active severe systemic allergy, seasonal allergies, rhinitis or sinusitis requiring treatment (i.e. antihistamines, decongestants, oral or aerosol steroids).

• Use of steroids, including administration by systemic, inhaled or topical ocular routes (dermatologic steroids not applied to the eyelids are allowed).

• Participation in a clinical trial during the past 30 days

• Women who are pregnant, planning a pregnancy, or nursing at study entry

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca
• Mild to Moderate Dry Eye Disease

Intervention

Device:
• Restylane Defyne
Restylane is a gel of hyaluronic acid generated by Streptococcus species of bacteria, chemically crosslinked with BDDE, stabilized and suspended in phosphate buffered saline at pH=7 and concentration of 20 mg/mL

Locations

Country	Name	City	State
United States	The Eye Care Institute	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
John C Meyer, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluating change in Schirmer score from baseline	Maximum length of tears absorbed on test strips recorded.	42 days after screening visit
Secondary	Evaluating change in Ocular Surface Disease index (OSDI) score from baseline	Participants answer 12 question questionnaire. Scores from section I,II, and III	42 days after screening visit
Secondary	Evaluating change in corneal staining score from baseline.	1.0mg sodium fluorescein strips on lower eye lids for one minute. 5 corneal regions graded using cobalt filter to maximized view of fluorescence.	42 days after screening visit
Secondary	Evaluating Tear break-up time (TBUT) from baseline.	Performed by Keratograph 5M per manufacturer's directions.	42 days after screening visit
Secondary	Evaluating tear meniscus height from baseline.	Performed by Keratograph 5M per manufacturer's directions.	42 days after screening visit.