Phase 3
N=79
A Study to Compare a New Eye Drop Formulation With Systane® Gel Drops and Genteal® Lubricant Gel Drops for Moderate to Severe Dry Eye Relief
Dry Eye Syndromes
Bottom Line
View on ClinicalTrials.gov: NCT02455050 ↗Enrolled (actual)
79
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcome: Primary: Tolerability Survey Score Using a 100 Unit Visual Analog Scale (VAS) in Period 1 — 255.74; 280.17; 284.89; 255.83 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Carboxymethylcellulose Sodium Based Eye Drops (Drug); Systane® Gel Drops (Drug); Genteal® Lubricant Gel Drops (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tolerability Survey Score Using a 100 Unit Visual Analog Scale (VAS) in Period 1 |
255.74; 280.17; 284.89; 255.83; 86.11; 134.89 | — |
| PRIMARY Tolerability Survey Score Using a 100 Unit Visual Analog Scale (VAS) in Period 2 |
231.33; 295.00; 298.82; 272.12; 102.00; 120.00 | — |
| SECONDARY Ocular Surface Disease Index© (OSDI©) Score Using a 5-Point Scale in Period 1 |
34.76; 36.98; 37.39; 34.79; 27.45; 25.89 | — |
| SECONDARY Ocular Surface Disease Index© (OSDI©) Score Using a 5-Point Scale in Period 2 |
21.98; 20.36; 18.06; 23.08; 25.88; 21.77 | — |
| SECONDARY Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 1 |
60; 74; 75; 75; 70; 74 | — |
| SECONDARY Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 2 |
64; 60; 70; 70; 79; 60 | — |
| SECONDARY Subjective Evaluation of Symptoms of Dryness (SESoD) Score Using a 5-Point Scale in Period 1 |
2.50; 2.21; 2.10; 2.40; 2.26; 1.94 | — |
| SECONDARY Subjective Evaluation of Symptoms of Dryness (SESoD) Score Using a 5-Point Scale in Period 2 |
1.56; 1.50; 1.67; 1.84; 1.50; 2.11 | — |
| SECONDARY Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Systane®) |
31; 33; 28; 26; 36; 31 | — |
| SECONDARY Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Genteal®) |
22; 42; 20; 22; 45; 18 | — |
| SECONDARY Distance Visual Acuity in Period 1 |
46.05; 46.28; 49.00; 47.44; 47.32; 50.78 | — |
| SECONDARY Distance Visual Acuity in Period 2 |
48.56; 46.56; 47.35; 48.65; 51.00; 51.11 | — |
| SECONDARY Tear Break-Up Time With Fluorescein in Period 1 |
5.17; 5.45; 4.99; 4.27; 6.21; 5.24 | — |
| SECONDARY Tear Break-Up Time With Fluorescein in Period 2 |
6.31; 6.13; 4.93; 5.63; 5.68; 6.34 | — |
| SECONDARY Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 1 |
3.32; 3.39; 3.58; 3.17; 3.53; 3.78 | — |
| SECONDARY Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 2 |
3.22; 3.22; 3.82; 3.76; 3.67; 3.28 | — |
Summary
A study to evaluate the tolerability and acceptability of an investigational eye drop formulation in patients with Dry Eye Disease.
Eligibility Criteria
Inclusion Criteria
- Current use of an artificial tear product
- Visual Acuity of at least 20/40 (while wearing glasses, if necessary).
Exclusion Criteria
- Use of contact lenses in the last 3 months, or anticipated use of contact lenses during the study
- Cataract surgery, laser-assisted in situ keratomileusis (LASIK), photorefractive keratectomy within 6 months
- Use of RESTASIS® Cyclosporine Ophthalmic Emulsion or any topical cyclosporine within 3 months
- Diagnosis of glaucoma.
Data sourced from ClinicalTrials.gov (NCT02455050). 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.