NCT02081677

One Month Daily Wear Clinical Evaluation of New Prototype Contact Lenses in Habitual and Neophyte Contact Lens Wearers

Completed NA Results posted Last updated 19 June 2018

What this trial tests

NA trial testing ACUVUE 2 in Visual Correction in 80 participants. Completed in 25 June 2014.

Timeline

6 February 2014

Primary endpoint
25 June 2014

25 June 2014

Quick facts

Lead sponsor	Johnson & Johnson Vision Care, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	80
Start date	6 February 2014
Primary completion	25 June 2014
Estimated completion	25 June 2014
Sites	1 location across India

Drugs / interventions tested

• ACUVUE 2
• Prototype E1
• Prototype E2
• Prototype E3

Conditions studied

• Visual Correction — all drugs for Visual Correction →

Sponsor

Johnson & Johnson Vision Care, Inc. — full company profile →

Who can join

Adults 18 to 39, any sex, with Visual Correction. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Corneal Staining (Area) Primary · Baseline and 4-Week Follow-up

Corneal Staining Area was collected at baseline and 4- week evaluations in both eyes using a slit lamp and was graded with a 11-point scale (i.e. Grade 0= 0% of region covered, Grade 1 =10% of region covered, Grade 2 = 20% of region covered, Grade 3 = 30% of region covered, Grade 4= 40% of region covered, Grade 5 = 50% of region covered, Grade 6 = 60% of region covered,Grade 7 = 70% of region covered, Grade 8 = 80% of region covered, Grade 9 = 90% of region covered and Grade 10 = 100% of region covered). Central, interior, nasal, temporal and superior locations were evaluated. The average grad

Baseline

Group	Value	95% CI
Etafilcon A	11.76	± 24.676
Prototype E1	5.79	± 18.4
Prototype E2	4.17	± 6.918
Prototype E3	6.18	± 17.925

4-week Follow-up

Group	Value	95% CI
Etafilcon A	5.29	± 12.367
Prototype E1	4.21	± 9.482
Prototype E2	8.06	± 7.491
Prototype E3	9.69	± 8.224

Corneal Staining (Depth) Primary · Baseline and 4-Week Follow-up

Corneal Staining Depth was collected at baseline and 4- week evaluations in both eyes using a slit lamp and was graded with a 4-point scale (i.e. Grade 0= None, Grade 1 =Superficial epithelial, Grade 2 = Full epithelial, Grade 3 =stromal glow). Central, interior, nasal, temporal and superior locations were evaluated. The average grade for each lens and time point was reported.

Baseline

Group	Value	95% CI
Etafilcon A	1.03	± 2.037
Prototype E1	0.45	± 1.224
Prototype E2	0.36	± 0.593
Prototype E3	0.44	± 1.045

4-week Follow-up

Group	Value	95% CI
Etafilcon A	0.53	± 1.237
Prototype E1	0.42	± 0.948
Prototype E2	0.81	± 0.749
Prototype E3	0.97	± 0.822

Corneal Staining (Type) Primary · Baseline and 4-Week Follow-up

Corneal Staining was collected at baseline and 4- week evaluations in both eyes using a slit lamp and was graded with a 5-point scale (i.e. Grade 0= None, Grade 1 =Micropunctate, Grade 2 = Macropunctate, Grade 3 = Coalesced Macropunctate and Grade 4 = Patch (greater or equal to 1mm). Central, interior, nasal, temporal and superior locations were evaluated. The average grade for each lens and time point was reported.

Baseline

Group	Value	95% CI
Etafilcon A	1.03	± 2.037
Prototype E1	0.58	± 1.840
Prototype E2	0.42	± 0.692
Prototype E3	0.59	± 1.829

4-week Follow-up

Group	Value	95% CI
Etafilcon A	0.53	± 1.237
Prototype E1	0.42	± 0.948
Prototype E2	0.81	± 0.749
Prototype E3	0.94	± 0.801

Limbal Conjunctival Redness Primary · Baseline and 2-Week Follow-up

Limbal Conjunctival Redness was assessed for each subject and eye at baseline and 2-week follow-up evaluations. Limbal Redness was assessed in 4 regions Inferior, Nasal, Temporal and Superior and Graded using an Efron Grading scale for limbal redness in 0.5 unit increments (Grade 0:None, Grade 1:Trace, Grade 2: Mild, Grade 3: Moderate and Grade 4: Severe). The average Grade across all four regions can range from 0 to 16 where lower values indicate better performance. The average Grade for each individual region can range from 0 to 4. The average grade across all regions was reported for each l

Baseline

Group	Value	95% CI
Etafilcon A	4.0	± 1.822
Prototype E1	3.50	± 1.564
Prototype E2	3.72	± 1.485
Prototype E3	4.06	± 1.294

2-week Follow-up

Group	Value	95% CI
Etafilcon A	3.93	± 1.441
Prototype E1	3.54	± 1.472
Prototype E2	3.72	± 1.446
Prototype E3	3.53	± 1.646

Bulbar Conjunctival Redness Primary · Baseline and 2-Week Follow-up

Bulbar Conjunctival Redness was assessed for each subject and eye at baseline and 2-week follow-up evaluations. Bulbar Redness was assessed in 4 regions Inferior, Nasal, Temporal and Superior and Graded using an Efron Grading scale for bulbar redness in 0.5 unit increments (Grade 0:None, Grade 1:Trace, Grade 2: Mild, Grade 3: Moderate and Grade 4: Severe). The average Grade across all four regions can range from 0 to 16 where lower values indicate better performance. The average Grade for each individual region can range from 0 to 4. The average grade across all regions was reported for each l

Baseline

Group	Value	95% CI
Etafilcon A	4.04	± 1.378
Prototype E1	4.12	± 1.416
Prototype E2	4.08	± 1.099
Prototype E3	4.24	± 1.136

2-week Follow-up

Group	Value	95% CI
Etafilcon A	4.13	± 1.170
Prototype E1	4.47	± 0.870
Prototype E2	4.18	± 1.166
Prototype E3	4.28	± 1.431

Visual Acuity (LogMAR) Primary · 4-Week Follow-up

Visual Acuity (LogMAR) was assessed bionocularly at the 4-week follow-up evaluations. The average visual acuity (LogMAR) for each lens was reported.

Group	Value	95% CI
Etafilcon A	-0.15	± 0.078
Prototype E1	-0.12	± 0.067
Prototype E2	-0.13	± 0.076
Prototype E3	-0.13	± 0.086

Lens Fitting Characteristics Primary · Post Lens Fitting and 4-Week Follow-up

Lens fit was assessed for each subject eye at post lens fitting and 4- week follow-up evaluations. Lens fit is a binary response as acceptable or unacceptable lens fit. The percentage of eyes with acceptable lens fit was reported.

Post Lens Fitting

Group	Value	95% CI
Etafilcon A	100
Prototype E1	100
Prototype E2	100
Prototype E3	100

4-week Follow-up

Group	Value	95% CI
Etafilcon A	100
Prototype E1	100
Prototype E2	100
Prototype E3	100

Percentage of Reported Ocular Symptoms (Burning/Stinging) Primary · Baseline and 4-Week Follow-up

The Ocular symptom Burning/Stinging was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.

Baseline

Group	Value	95% CI
Etafilcon A	5.9
Prototype E1	0.0
Prototype E2	0.0
Prototype E3	0.0

4- Week Follow-up

Group	Value	95% CI
Etafilcon A	0.0
Prototype E1	0.0
Prototype E2	0.0
Prototype E3	6.3

Corneal Edema Primary · Baseline and 4-Week Follow-up

Corneal Edema was assessed using a bio-microscope at baseline and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The Percentage of eyes with Grade 3 or higher was reported.

Baseline

Group	Value	95% CI
Etafilcon A	0
Prototype E1	0
Prototype E2	0
Prototype E3	0

4-week Follow-up

Group	Value	95% CI
Etafilcon A	0
Prototype E1	0
Prototype E2	0
Prototype E3	0

Conjunctival Injection Primary · Baseline and 4-Week Follow-up

Conjunctival Injection was assessed using a bio-microscope at baseline and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The Percentage of eyes with Grade 3 or higher was reported.

Baseline

Group	Value	95% CI
Etafilcon A	0
Prototype E1	0
Prototype E2	0
Prototype E3	0

4-week Follow-up

Group	Value	95% CI
Etafilcon A	0
Prototype E1	0
Prototype E2	0
Prototype E3	0

Corneal Neovascularization Primary · Baseline and 4-Week Follow-up

Corneal Neovascularization was assessed using a bio-microscope at baseline and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The Percentage of eyes with Grade 3 or higher was reported.

Baseline

Group	Value	95% CI
Etafilcon A	0
Prototype E1	0
Prototype E2	0
Prototype E3	0

4-week Follow-up

Group	Value	95% CI
Etafilcon A	0
Prototype E1	0
Prototype E2	0
Prototype E3	0

Corneal Staining Primary · Baseline and 4-Week Follow-up

Corneal Staining was assessed using a bio-microscope at baseline and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The Percentage of eyes with Grade 3 or higher was reported.

Baseline

Group	Value	95% CI
Etafilcon A	0
Prototype E1	0
Prototype E2	0
Prototype E3	0

4-week Follow-up

Group	Value	95% CI
Etafilcon A	0
Prototype E1	0
Prototype E2	0
Prototype E3	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Throughout the duration of the study. Approximately 5 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Etafilcon A

Serious: 0/19 (0%)

Deaths: —

Prototype E1

Serious: 0/19 (0%)

Deaths: —

Prototype E2

Serious: 0/19 (0%)

Deaths: —

Prototype E3

Serious: 0/19 (0%)

Deaths: —

Other adverse events (5 terms — click to expand)

Reaction	System	Etafilcon A	Prototype E1	Prototype E2	Prototype E3
Non-significant Ocular Event	Eye disorders	—	—	—	—
Low Blood Pressure	Blood and lymphatic system disorders	—	—	—	—
Upset Stomach	Gastrointestinal disorders	—	—	—	—
Muscle Sprain	Musculoskeletal and connective tissue disorders	—	—	—	—
Minimal Skin Bruises	Blood and lymphatic system disorders	—	—	—	—

Data from ClinicalTrials.gov NCT02081677 adverse events section.

Sponsor's own description

There will be four study lenses tested; one marketed lens, and three prototype study lenses. Subjects will be randomized to one of the four study lenses which will be worn in a daily wear modality, with a two week replacement.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.