Clinical trial NCT00630305: Endothelial Bleb Response With Toric Lenses
Official title: Evaluation of the Short-Term Corneal Endothelial Response to Wear of Toric Soft Contact Lenses in Asian Eyes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ametropia
Keywords: toric
endothelial bleb
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2008-03-07
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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 open eye and closed eye state.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Endothelial Bleb Areas on Cornea: Session A- Open Eye
timeFrame: 20 minutes post-lens insertion
measure: Endothelial Bleb Areas on Cornea: Session B- Closed Eye
timeFrame: 20 minutes post-lens insertion
measure: Endothelial Bleb Areas on Cornea: Session C- Open Eye
timeFrame: 20 minutes post-lens insertion
measure: Endothelial Bleb Areas on Cornea: Session D- Closed Eye
timeFrame: 20 minutes post-lens insertion
Secondary outcomes:
Other outcomes:
Locations:
city: Auburn Village
country: Australia
facility: Brennan Consultants 110 Auburn Rd
state: Victoria
Study officials:
affiliation: Brennan Consultants
name: Noel A Brennan, McOptom PhD
role: PRINCIPAL_INVESTIGATOR
References: