Endothelial Bleb Response With Toric Lenses

Vision Correction Clinical Trial

Official title:

Evaluation of the Short-Term Corneal Endothelial Response to Wear of Toric Soft Contact Lenses in Asian Eyes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00630305
• Other study ID #: CR-0726
• Secondary ID: JJO0717
• Status: Completed
• Phase: N/A
• First received: February 28, 2008
• Last updated: August 19, 2008
• Start date: January 2008
• Est. completion date: July 2008

Study information

• Verified date: August 2008
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Interventional

Clinical Trial Summary

Evaluate the short-term corneal response of oxygen deprivation when using toric contact lenses. The response will be noted by endothelial bleb formation in both and open eye and closed eye state. Hypotheses: senfilcon A toric will have at least as low endothelial bleb formation as two other toric lenses in both the open/closed eye states.

Description:

Interested subjects who meet the entry criteria for the study will be scheduled for four sessions of approximately 30 minutes duration each. Informed consent obtained. Baseline measurements of visual acuity and corneal and conjunctival physiology will be recorded. An examination of the endothelium of the corneas will be conducted using the specular microscope, readings obtained at 5 locations on each cornea: one in the centre and one in each of the superior, inferior, nasal and temporal peripheral regions, approximately 2mm from the limbal margin. The assigned lenses will be inserted according to a fixed-allocation randomization schedule, where each session follows an optimized 2- period simultaneous crossover design, which specifies lenses to be used in each of the four sessions. Lenses will be worn for 20 minutes and then removed. Endothelial specular microscopy will be conducted at 20 minutes with the lenses on. A final evaluation of corneal and conjunctival physiology will be performed prior to subject clearance from the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Successful soft contact lens wear in daily mode for a minimum of 1 month prior to start of the study without experiencing difficulties or contact lens related complications.

2. At least 18 years of age and mentally competent to sign an informed consent form.

3. Healthy eyes and no use of ocular medication.

4. Similarity of optical parameters between eyes.

5. Physical appearance typical of Asian eyes

Exclusion Criteria:

1. A medical or ocular condition that may influence the outcome of this trial.

2. Current use of ocular/systemic medication that may influence the outcome of this trial.

3. Failure to wear soft lenses for 2 weeks prior to the start of the study.

4. Current enrolment or participation in another clinical study.

5. Current state of pregnancy or breastfeeding

6. Anisometropia greater than 1.00D (equivalent sphere).

7. Unequal acuities between eyes (greater than 1 line)

8. Unequal corneal curvatures (>1.00D)

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vision Correction

Intervention

Device:
• toric contact lenses
30 minutes of contact lens wear for each arm for two states; open eye and closed eye
• toric contact lenses
30 minutes of contact lens wear for each arm for two states; open eye and closed eye
• toric contact lenses
30 minutes of contact lens wear for each arm for two states; open eye and closed eye

Locations

Country	Name	City	State
Australia	Brennan Consultants 110 Auburn Rd	Auburn Village	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Grade of percent of endothelial blebs in the following locations; Central, Nasal, Temporal, Inferior, Superior		20 minutes	No