Trial · NCT03660475

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

NCT03660475, Phase 2, Completed, Sassani, Joseph S., MD, MHA; results first posted 2022-12-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Effect of Topical Naltrexone Ophthalmic Solution on the Signs and Symptoms of Dry Eye in Diabetic Subjects. Trials, record NCT03660475. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03660475

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Effect of Topical Naltrexone Ophthalmic Solution on the Signs and Symptoms of Dry Eye in Diabetic Subjects
NCT number: NCT03660475
Status: Completed
Phases: Phase 2
Enrollment: 60 participants, actual
Lead sponsor: Sassani, Joseph S., MD, MHA
Conditions: Dry Eye Disease
Interventions: Naltrexone, Placebos
First posted: 2018-09-06
Last updated: 2022-12-02
Results first posted: 2022-12-02
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.

Source ClinicalTrials.gov

Registered outcomes17

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Total Ocular Surface Disease Index	Day 29	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.
Secondary	Lissamine Green Staining	Day 29	Lissamine green staining; regions: inferior, superior, central, corneal sum, temporal, nasal, conjunctival sum, total eye will be measured using an ocular discomfort score on a scale of 0 (no staining) to 4 (confluent staining). The total eye score is presented. A minimum score would be "0" and a maximal score would be "8". The higher the value the worse the outcome.
Secondary	Tear Film Break-up Time	Day 29	Tear film break-up time is the time taken for the first dry spot to appear on the cornea after a complete blink.
Secondary	Conjunctival Redness	Day 29	Conjunctival redness will be assessed and conjunctival pain will be assessed using a visual analog scale ranging from "0" (none: normal without vasodilation) to "5" (severe: broad ciliary and prominent, horizontal conjunctival vasodilation). A minimal score would be "0" and a maximal score would be "10". The higher the value the worse the outcome .
Secondary	Schirmer's Test	Day 29	Schirmer's Test (without anesthesia) ) involves placing a Schirmer test strip in the lower temporal lid margin of each eye such that the strip fits tightly. Subjects will be instructed to close their eyes. After 5 minutes have elapsed, the Schirmer strip will be removed. The length of the moistened area will be recorded (mm) for each eye. A normal reading is ≥10 mm wetting of the paper after 5 minutes. Tear deficiency is \<5 mm wetting of the paper after 5 minutes.
Secondary	Cochet-Bonnet Corneal Sensitivity Test	Day 29	After extending the Cochet-Bonnet corneal sensitivity device (containing a thin, retractable, nylon monofilament) up to 6 cm in length and pressing against the cornea, the monofilament is slowly retracted incrementally in 0.5 cm steps until the patient can feel its contact and the length is recorded. The greater the length indicates increased sensation and the shorter the length indicates decreased sensation.
Secondary	Tear Osmolarity	Day 29	Normal tear osmolarity is defined as \< 300 mOsm/L in both eyes and an inter-eye difference of \< 8 mOsm/L. Values greater than 300 mOsm/L are suggestive of dry eye.
Secondary	Matrix Metalloprotienase-9 (MMP-9) is a Marker of Inflammation.	Day 29	Levels of MMP-9 will be measured in each eye using InflammaDry at Visit 5. The test will be recorded as either positive or negative. Dry eye patients generally exhibit positive levels of MMP-9., so the number of subjects testing positive for MMP-9 at Day 29 will be recorded.
Secondary	Ocular Discomfort (Scale 1)	Day 29	Ocular discomfort scores will be subjectively graded by the subjects according to the following scale, rating each eye separately on a scale from 0-4. A score of "0" represents no discomfort and a score of "4" represents constant discomfort. A minimum score would be "0" and a maximum score would be "8". The higher the value the worse the outcome.
Secondary	Ocular Discomfort (Scale 2)	Day 29	Subjects will rate the severity of each of the following symptoms, with regard to how both their eyes feel: overall ocular discomfort, burning, dryness, grittiness and stinging according to the following 6-point (0 to 5) scale where 0 = none and 5 = worst. A minimum score would be "0" and a maximum score would be "10". The higher the value the worse the outcome.

1 to 10 of 17Source ClinicalTrials.gov

See all 17 registered outcomes

Outcomes17

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Total Ocular Surface Disease Index	Day 29	score on a scale	MEAN
SECONDARY	Lissamine Green Staining	Day 29	score on a scale	MEAN
SECONDARY	Tear Film Break-up Time	Day 29	seconds	MEAN
SECONDARY	Conjunctival Redness	Day 29	score on a scale	MEAN
SECONDARY	Schirmer's Test	Day 29	mm	MEAN
SECONDARY	Cochet-Bonnet Corneal Sensitivity Test	Day 29	cm	MEAN
SECONDARY	Tear Osmolarity	Day 29	mOsm/L	MEAN
SECONDARY	Matrix Metalloprotienase-9 (MMP-9) is a Marker of Inflammation.	Day 29	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Ocular Discomfort (Scale 1)	Day 29	score on a scale	MEAN
SECONDARY	Ocular Discomfort (Scale 2)	Day 29	score on a scale	MEAN

1 to 10 of 17Source ClinicalTrials.gov

See all 17 outcomes

Results by group34

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Total Ocular Surface Disease Index	Naltrexone	21.17	Standard Deviation 17.72	score on a scale
Total Ocular Surface Disease Index	Placebo	21.36	Standard Deviation 17.16	score on a scale
Lissamine Green Staining	Naltrexone	2.65	Standard Deviation 1.10	score on a scale
Lissamine Green Staining	Placebo	2.59	Standard Deviation 1.25	score on a scale
Tear Film Break-up Time	Naltrexone	2.76	Standard Deviation 0.98	seconds
Tear Film Break-up Time	Placebo	3.48	Standard Deviation 2.49	seconds
Conjunctival Redness	Naltrexone	1.0	Standard Deviation 0.41	score on a scale
Conjunctival Redness	Placebo	1.0	Standard Deviation 0.45	score on a scale
Schirmer's Test	Naltrexone	8.97	Standard Deviation 8.00	mm
Schirmer's Test	Placebo	12.48	Standard Deviation 9.20	mm

1 to 10 of 34Source ClinicalTrials.gov

See all 34 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Naltrexone	30
Overall Study	STARTED	Placebo	30
Overall Study	COMPLETED	Naltrexone	30
Overall Study	COMPLETED	Placebo	30
Overall Study	NOT COMPLETED	Naltrexone	0
Overall Study	NOT COMPLETED	Placebo	0

Source ClinicalTrials.gov

Adverse events6

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Swelling of upper lip	Skin and subcutaneous tissue disorders	Naltrexone	0	30
other	Swelling of upper lip	Skin and subcutaneous tissue disorders	Placebo	1	30
other	Increase in A1C	Metabolism and nutrition disorders	Naltrexone	0	30
other	Increase in A1C	Metabolism and nutrition disorders	Placebo	1	30
other	Rotator cuff pain	Musculoskeletal and connective tissue disorders	Naltrexone	0	30
other	Rotator cuff pain	Musculoskeletal and connective tissue disorders	Placebo	1	30

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Naltrexone	0	30
Total, all-cause mortality	Placebo	0	30
Total, other adverse events	Naltrexone	0	30
Total, other adverse events	Placebo	1	30
Total, serious adverse events	Naltrexone	0	30
Total, serious adverse events	Placebo	0	30

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons6

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Naltrexone vs Placebo: Dilated Fundoscopy	Trial comparisons
Naltrexone vs Placebo: Number of Participants With Treatment-related Adverse Events	Trial comparisons
Naltrexone vs Placebo: Slit-lamp Biomicroscopy	Trial comparisons
Naltrexone vs Placebo: Matrix Metalloprotienase-9 (MMP-9) is a Marker of Inflammation.	Trial comparisons
Naltrexone vs Placebo: deaths from any cause	Trial comparisons
Naltrexone vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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