Effect of Topical Naltrexone Ophthalmic Solution on the Signs and Symptoms of Dry Eye in Diabetic Subjects

NCT03660475 | Completed Phase 2 Results FDA Drug

• 1 other identifier: DDES001/18-110-0002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this exploratory study is to determine the safety and efficacy of 0.002% Naltrexone Ophthalmic Solution, compared to placebo for the treatment of the signs and symptoms of dry eye in diabetic subjects.

Conditions

Dry Eye Disease

Keywords

naltrexone; dry eye; diabetic subjects

Outcome Measures

Primary Outcomes (1)

• Total Ocular Surface Disease Index

  The OSDI is a 12-item questionnaire designed to provide a rapid assessment of the symptoms of ocular irritation consistent with dry eye disease and their impact on vision-related functioning. It is a scale of 0-4 for each of the 12 questions. A minimum value would be "0" and a maximum value would be "48". The higher the value the worse the outcome.

  Day 29

Secondary Outcomes (12)

• Lissamine Green Staining

  Day 29

• Tear Film Break-up Time

  Day 29

• Conjunctival Redness

  Day 29

• Schirmer's Test

  Day 29

• Cochet-Bonnet Corneal Sensitivity Test

  Day 29

Other Outcomes (4)

• Number of Participants With Treatment-related Adverse Events

  Adverse events will be collected from first dose of study drug to 30 days after treatment discontinuation (Day 29 + 4 weeks).

• Slit-lamp Biomicroscopy

  Day 29

• Intraocular Pressure

  Day 29

Study Arms (2)

Naltrexone

EXPERIMENTAL

Naltrexone Ophthalmic Solution 0.002%

Drug: Naltrexone

Placebo

PLACEBO COMPARATOR

Placebo Ophthalmic Solution

Drug: Placebos

Interventions

Naltrexone DRUG

naltrexone formulated as ophthalmic solution

Naltrexone

Placebos DRUG

Placebo ophthalmic solution

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide written informed consent;
• Have a diagnosis of type 1 or type 2 diabetes mellitus prior to Visit 1;
• Have a reported history of dry eye for at least 6 months prior to Visit 1;
• Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1;
• Have a corneal fluorescein staining score of ≥ 2 in any region (inferior, superior, or central regions) in at least one eye at Visits 1 and 2 (must be the same eye at Visits 1 and 2);
• Have at least one of the following at Visits 1 and 2:
• A total lissamine green conjunctival score of ≥ 2 in at least one eye, based on the sum of the temporal and nasal regions at Visits 1 and 2 (must be the same eye at Visits 1 and 2);
• Report an OSDI score ≥ 20 at Visits 1 and 2.

You may not qualify if:

• Have any clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
• Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
• Have concurrent neurotrophic keratopathy from a source other than diabetes (h/o HSV keratitis, h/o HZO with ocular manifestations, or CN VII palsy or other condition resulting in lagophthalmos);
• Have active diabetic foot ulcers;
• Have a corneal sensitivity score ≤ 1.5 cm as measured by Cochet-Bonnet at Visit 1;
• Report an OSDI score \> 75 at Visits 1 and 2;
• Have worn contact lenses within 21 days of Visit 1 or anticipate using contact lenses during the study (no contact lens wear during study);
• Have used any eye drops within 2 hours of Visit 1;
• Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 24 months;
• Have used cyclosporine 0.05% or lifitigrast 5.0% ophthalmic solution within 45 days of Visit 1;
• Have any planned ocular and/or lid surgeries over the study period or any ocular surgery within the last 12 months;
• Be using or anticipate using temporary punctal plugs during the study that have not been stable within 30 days of Visit 1;
• Be currently taking any topical ophthalmic prescription (including medications for glaucoma) or over-the-counter (OTC) solutions, artificial tears, gels or scrubs, and cannot discontinue these medications for the duration of the trial (excluding medications allowed for the conduct of the study);
• Have corrected visual acuity greater than or equal to logMAR +0.7 as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) scale in either eye at Visit 1;
• Have concurrent autoimmune disease causing dry eye (e.g., rheumatoid arthritis, Sjogren's, GVHD, Steven's Johnson, Grave's);

Sponsors & Collaborators

• Sassani, Joseph S., MD, MHA: lead

Study Sites (1)

Total Eye Care

Memphis, Tennessee, 38119, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

Please note that no specific primary endpoint was identified in the protocol. The study was exploratory in nature looking at both efficacy and safety parameters to help inform future studies.

Results Point of Contact

• Title: Joseph Sassani, MD, MHA
• Organization: Penn State Hershey Medical Center

jsassani@pennstatehealth.psu.edu

717 531 8783

Study Officials

• Eugene B McLaurin, M.D.

  Total Eye Care

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2018
• First Posted: September 6, 2018
• Study Start: July 31, 2018
• Primary Completion: November 1, 2018
• Study Completion: November 15, 2018
• Last Updated: December 2, 2022
• Results First Posted: December 2, 2022

Record last verified: 2022-10

Locations

US (1)