Phase 3
N=120
A Study to Evaluate the Efficacy of Investigational OTC Eye Drops
Ophthalmic Solutions
Bottom Line
View on ClinicalTrials.gov: NCT03198000 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcome: Primary: Clinician Assessment of Change From Baseline in Redness at 60 Seconds After First Product Application — 0.31; 0.27; 0.32 units on a scale — p=0.392
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- F# 13418-148 Eye Drops (Drug); F#13418-158 Eye Drops (Drug); F# PF-004390 Eye Drops (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinician Assessment of Change From Baseline in Redness at 60 Seconds After First Product Application |
0.31; 0.27; 0.32 | 0.392 |
| PRIMARY Percentage of Participants With Response to Redness at 60 Seconds After First Product Application |
53.6; 50.1; 50.1 | 0.576 |
| SECONDARY Clinician Assessment of Change From Baseline in Redness at 30 Seconds After First Product Application |
0.10; 0.09; 0.11 | 0.893 |
| SECONDARY Clinician Assessment of Change From Baseline in Redness at 2 Minutes After First Product Application |
0.88; 0.80; 0.83 | 0.117 |
| SECONDARY Clinician Assessment of Baseline Redness |
1.64; 1.66; 1.76 | — |
| SECONDARY Change From Baseline in Ocular Comfort at 60 Seconds After First Product Application |
-1.4; -1.1; -1.2 | 0.085 |
| SECONDARY Change From Baseline in Ocular Comfort at 10 Hours After First Product Application |
-1.4; -1.7; -1.6 | 0.162 |
| SECONDARY Change From Baseline in Ocular Comfort at 12 Hours After First Product Application |
-1.4; -1.5; -1.6 | 0.398 |
| SECONDARY My Eye Feels Hydrated - Baseline |
8.9; 10.1; 8.5; 30.4; 34.2; 28.0 | — |
| SECONDARY My Eye Feels Hydrated - 2 Minutes After First Application |
45.6; 39.2; 43.9; 48.1; 49.4; 42.7 | — |
| SECONDARY My Eye Feels Hydrated - 10 Hours After First Application |
31.6; 43.0; 29.3; 41.8; 35.4; 41.5 | — |
| SECONDARY My Eye Feels Hydrated - 12 Hours After First Application |
36.7; 35.4; 30.5; 43.0; 40.5; 41.5 | — |
| SECONDARY My Eye Feels Refreshed - 2 Minutes After First Application |
38.0; 36.7; 42.7; 46.8; 44.3; 36.6 | — |
| SECONDARY My Eye Feels Refreshed - 10 Hours After First Application |
32.9; 34.2; 32.9; 36.7; 45.6; 43.9 | — |
| SECONDARY My Eye Feels Refreshed - 12 Hours After First Application |
27.8; 30.4; 26.8; 38.0; 36.7; 37.8 | — |
| SECONDARY The Appearance of my Eye Gives me Confidence to Approach Others - Baseline |
43.0; 30.4; 30.5; 25.3; 31.6; 26.8 | — |
| SECONDARY The Appearance of my Eye Gives me Confidence to Approach Others - 2 Minutes After First Application |
46.8; 39.2; 37.8; 24.1; 32.9; 36.6 | — |
| SECONDARY The Appearance of my Eye Gives me Confidence to Approach Others - 10 Hours After First Application |
46.8; 51.9; 46.3; 29.1; 26.6; 28.0 | — |
| SECONDARY The Appearance of my Eye Gives me Confidence to Approach Others - 12 Hours After First Application |
38.0; 38.0; 30.5; 36.7; 32.9; 37.8 | — |
| SECONDARY The Appearance of my Eye Can Show How I Really Feel - Baseline |
34.2; 29.1; 25.6; 36.7; 40.5; 37.8 | — |
| SECONDARY The Appearance of my Eye Can Show How I Really Feel - 2 Minutes After First Application |
36.7; 34.2; 35.4; 34.2; 43.0; 40.2 | — |
| SECONDARY The Appearance of my Eye Can Show How I Really Feel - 10 Hours After First Application |
35.4; 31.6; 32.9; 31.6; 36.7; 31.7 | — |
| SECONDARY The Appearance of my Eye Can Show How I Really Feel - 12 Hours After First Application |
34.2; 35.4; 32.9; 38.0; 36.7; 40.2 | — |
| SECONDARY My Eye Appears Healthy - Baseline |
40.5; 41.8; 45.1; 35.4; 31.6; 25.6 | — |
| SECONDARY My Eye Appears Healthy - 2 Minutes After First Application |
46.8; 44.3; 42.7; 40.5; 34.2; 37.8 | — |
| SECONDARY My Eye Appears Healthy - 10 Hours After First Application |
48.1; 50.6; 48.8; 29.1; 27.8; 28.0 | — |
| SECONDARY My Eye Appears Healthy - 12 Hours After First Application |
54.4; 51.9; 47.6; 29.1; 22.8; 28.0 | — |
| SECONDARY My Eye Feels Cool - 2 Minutes After First Application |
29.1; 20.3; 29.3; 40.5; 44.3; 32.9 | — |
| SECONDARY My Eye Feels Cool - 10 Hours After First Application |
24.1; 20.3; 13.4; 29.1; 36.7; 34.1 | — |
| SECONDARY My Eye Feels Cool - 12 Hours After First Application |
20.3; 22.8; 17.1; 29.1; 27.8; 29.3 | — |
| SECONDARY My Eye Appears to Sparkle - Baseline |
3.8; 6.3; 9.8; 24.1; 20.3; 19.5 | — |
| SECONDARY My Eye Appears to Sparkle - 2 Minutes After First Application |
6.3; 8.9; 14.6; 34.2; 26.6; 20.7 | — |
| SECONDARY My Eye Appears to Sparkle - 10 Hours After First Application |
19.0; 15.2; 17.1; 29.1; 34.2; 28.0 | — |
| SECONDARY My Eye Appears to Sparkle - 12 Hours After First Application |
17.7; 13.9; 19.5; 29.1; 25.3; 24.4 | — |
Summary
This is a single center, double-blinded study designed to demonstrate the therapeutic equivalence of over-the-counter eye drops in healthy adults with red eyes.
Eligibility Criteria
Inclusion Criteria
- Able and willing to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based upon research site personnel's assessment;
- Able and willing to provide a signed and dated Informed Consent document and Authorization for the Release of Health Information for Research
- Male or female of any race or ethnicity, aged 18 years and older;
- Females of childbearing potential who have a negative urine pregnancy test at the Screening/Baseline visit (Visit 1);
- Able to read and understand English;
- Healthy subjects with redness in both eyes
- History of topical ocular drugs or desire to use within the last 6 months;
- Ocular health within normal limits,
- Male and female subjects with reproductive potential who agree to practice a medically acceptable form of birth control during the study and for 30 days following the last dose of investigational product. Females must have used such birth control for at least 3 months prior to the Screening/Baseline Visit 1.
Exclusion Criteria
- Suspected alcohol or substance abuse (e.g., amphetamines, benzodiazepines, cocaine, marijuana, opiates);
- Known sensitivity, allergy or contraindications to any investigational product ingredient;
- Females who are pregnant, planning to become pregnant or breastfeeding during the study;
- Subjects who were previously screened and determined to be ineligible for the study;
- Use of a therapeutic eye treatment (over-the-counter or prescription) within 2 days of the Screening/Baseline visit (Visit 1) and throughout study participation;
- Participation in any clinical study investigation within 30 days of Screening/Baseline visit (Visit 1);
- Relative, partner or staff of any clinical research site personnel;
- Active infection of any type at the start of the study; particularly, presence of active ocular infection (bacterial, viral, or fungal) or positive history of an ocular herpetic infection;
- Any ocular condition that could affect the subject's safety or trial parameter, such as severe ocular allergy;
- Planned surgery during the trial period, 6 months prior to clinic visit 1 or 30 days after the end of study period;
- Has a compromised immune system;
- Has any acute or chronic, medical or psychiatric conditions
- Contact lens use within 24 hours prior to clinic Visit 1 and during their participation in the study;
- Saline eye drop use within 24 hours prior to clinic Visit 1 and during their participation in the study;
- Use of any new OTC or prescription medications within 24 hours prior to clinic Visit 1 and throughout study participation.
Data sourced from ClinicalTrials.gov (NCT03198000). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.